Important Safety Information
Scroll to Learn More
important safety information
REferences
©2019 Alcon Inc. 11/19 US-LSX-1900012
Content Block 6
720 x 720
Content Block 5
720 x 720
IMPORTANT SAFETY INFORMATION
LENSX® LASER IMPORTANT PRODUCT INFORMATION
FOR CATARACT SURGERY, CORNEAL FLAP AND CORNEAL POCKETS & TUNNEL INCISIONS
CAUTION: Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner.
INDICATIONS FOR THE LENSX® LASER:
CATARACT SURGERY INDICATION: In the creation of corneal cuts/incisions (single-plane, multi-plane and arcuate) anterior capsulotomy and laser phacofragmentation during cataract surgery in adult patients. Each of these procedures may be performed either individually or consecutively during the same surgery.
CORNEAL FLAP INDICATION: For use in the creation of a corneal flap in adult patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
CORNEAL POCKETS AND TUNNELS: In adult patients, for the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings.
RESTRICTIONS: Patients must be able to lie flat and motionless in a supine position. Patient must be able to understand and give an informed consent. Patients must be able to tolerate local or topical anesthesia. Patients with elevated IOP should use topical steroids only under close medical supervision.
CONTRAINDICATIONS
CATARACT SURGERY CONTRAINDICATIONS: Corneal disease that precludes applanation of the cornea or transmission of laser light at 1030 nm wavelength. Descemetocele with impending corneal rupture. Presence of blood or other material in the anterior chamber. Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy. Conditions which would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only). Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape. Corneal thickness requirements that are beyond the range of the system. Corneal opacity that would interfere with the laser beam, Hypotony, glaucoma* or the presence of a corneal implant. Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease). History of lens or zonular instability. Any contraindication to cataract or keratoplasty. This device is not intended for use in pediatric surgery.
*Glaucoma is not a contraindication when these procedures are performed using the LenSx® Laser SoftFit® Patient Interface Accessory
CORNEAL SURGERY (FLAPS, POCKETS, TUNNELS) CONTRAINDICATIONS: Corneal lesions. Corneal edema. Hypotony. Glaucoma. Existing corneal implant. Keratoconus. This device is not intended for use in pediatric surgery. Flap creation, tunnels, pockets and cataract procedures cannot be combined into a single treatment.
WARNINGS : The LenSx® Laser System should only be operated by a physician trained in its use. The LenSx® Laser delivery system employs one sterile disposable Patient Interface consisting of an applanation lens and suction ring. The Patient Interface is intended for single use only. Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards.
PRECAUTIONS: Do not use cell phones or pagers of any kind in the same room as the LenSx® Laser. Discard used Patient Interfaces as medical waste.
COMPLICATIONS
CATARACT SURGERY AES/COMPLICATIONS: Corneal edema. Capsulotomy, phacofragmentation, or cut or incision decentration. Incomplete or interrupted capsulotomy, fragmentation, or corneal incision procedure. Capsular tear. Corneal abrasion or defect. Pain. Infection. Bleeding. Damage to intraocular structures. Anterior chamber fluid leakage, anterior chamber collapse. Elevated pressure to the eye.
CORNEAL SURGERY (FLAPS, POCKETS & TUNNELS) AES/COMPLICATIONS: Corneal edema. Corneal or eye pain. Corneal haze. Epithelial in-growth. Corneal abrasion or epithelial defect. Infection/keratitis. Corneal ectasia or endothelial perforation. Decentered flap or pattern; uneven flap bed. Incomplete dissection/inability to complete procedure. Flap tearing or incomplete lift-off. Free cap or buttonhole. Elevated pressure to the eye.
ATTENTION: Refer to the LenSx® Laser Operator’s Manual for a complete listing of indications, warnings and precautions.
VERION® IMAGE GUIDED SYSTEM IMPORTANT PRODUCT INFORMATION
VERION® REFERENCE UNIT AND VERION® DIGITAL MARKER
CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
INTENDED USES: The Verion® Reference Unit is a preoperative measurement device that captures and utilizes a high-resolution reference image of a patient’s eye. In addition, the Verion® Reference Unit provides pre-operative surgical planning functions to assist the surgeon with planning cataract surgical procedures. The Verion® Reference Unit also supports the export of the reference image, preoperative measurement data, and surgical plans for use with the Verion® Digital Marker and other compatible devices through the use of a USB memory stick. The Verion® Digital Marker links to compatible surgical microscopes to display concurrently the reference and microscope images, allowing the surgeon to account for lateral and rotational eye movements. In addition, details from the Verion® Reference Unit surgical plan can be overlaid on a computer screen or the physician’s microscope view.
CONTRAINDICATIONS: The following conditions may affect the accuracy of surgical plans prepared with the Verion® Reference Unit: a pseudophakic eye, eye fixation problems, a non-intact cornea, or an irregular cornea. In addition, patients should refrain from wearing contact lenses during the reference measurement as this may interfere with the accuracy of the measurements. The following conditions may affect the proper functioning of the Verion® Digital Marker: changes in a patient’s eye between preoperative measurement and surgery, an irregular elliptic limbus (e.g., due to eye fixation during surgery, and bleeding or bloated conjunctiva due to anesthesia). In addition, the use of eye drops that constrict sclera vessels before or during surgery should be avoided.
WARNINGS: Only properly trained personnel should operate the Verion® Reference Unit and Verion® Digital Marker. Use only the provided medical power supplies and data communication cable. Power supplies for the Verion® Reference Unit and the Verion® Digital Marker must be uninterruptible. Do not use these devices in combination with an extension cord. Do not cover any of the component devices while turned on. The Verion® Reference Unit uses infrared light. Unless necessary, medical personnel and patients should avoid direct eye exposure to the emitted or reflected beam.
PRECAUTIONS: To ensure the accuracy of Verion® Reference Unit measurements, device calibration and the reference measurement should be conducted in dimmed ambient light conditions. Only use the Verion® Digital Marker in conjunction with compatible surgical microscopes.
ATTENTION: Refer to the user manuals for the Verion® Reference Unit and the Verion® Digital Marker for a complete description of proper use and maintenance of these devices, as well as a complete list of contraindications, warnings and precautions.
Trusted in more than 2 MILLION cataract procedures
The LenSx®Laser is Alcon’s clinically proven femtosecond platform that creates reproducible cataract outcomes
Proven Precision
Proven Safety
Proven Efficiency
Proven Outcomes
Proven Precision
Reproducibility and accuracy at every step
Versus manual procedures, LenSx®delivers:
More precise, reproducible and reliable capsulotomies
More accurate, more efficient, and less damaging self-sealing cataract incision in terms of architecture, size and geometry
Less variability of anterior chamber depth with more stable post-op refraction
Get it right the first time
98.6%
of anterior capsulotomies achieved without manual separation of residual tags
of corneal incisions could be opened by a blunt spatula
97.6%
of fragmentations required no additional segmentation after the laser procedure
99.5%
The SoftFit®Patient Interface
Experience greater precision with the hydrogel lens insert of the LenSx®Laser
Connectivity to the VERION®Image
Guided System delivers a new level of certainty
LEARN MORE ABOUT VERION®
*Prospective, multicenter study investigated performance of FLACS at 1 month post-op in Chinese patients (n = 1542 eyes).
Proven Safety
<2 minutes
total time for patients under suction in cataract procedures
As strong as manual
LenSx®capsulotomy
integrity
<0.1%
capsular tear rate with SoftFit®Patient Interface
LenSx®vs Manual Procedures
Superior
endothelial cell retention at 1 and 3 months
Improved
central corneal thickness at Day 1 for quieter eyes
Faster
rehabilitation in hard cataracts, along with less phaco power and endothelial cell damage
Lower
rate of YAG capsulotomies
less phaco energy
less phaco time
Proven Outcomes
A greater proportion of eyes treated reach emmetropia (±0.5 D) than those treated with manual surgery
of eyes fall within 0.5 D of target refraction vs 83.1% with manual
less mean postoperative astigmatism vs manual cases (0.32 D vs 0.65 D) §
†Capsulotomy and phacofragmentation procedures were evaluated in porcine eyes (n = 8 for manual, n = 10 for LenSx®group).
‡Retrospective chart review of 225 patients for LenSx®and manual groups.
§Retrospective chart review of 231 patients for LenSx®and manual groups.
Proven Efficiency
Built for performance, built for speed
Customize your approach to each patient with versatile fragmentation
• Empowers efficient treatment for a variety of lens densities
• Significantly reduces phaco time and energy
On average, laser cataract patients spend less time in the OR
Added Versatility for Your Femtosecond Performance
The LenSx®Laser has been enhanced to allow for more corneal applications
• Delivers consistent flap thickness and smooth edges
• Provides surgeon-selectable flap location, hinge, and side-cut parameters
• Creates a uniform bubble layer for easier lifting of the flap
• Helps minimize appearance of an opaque bubble layer
Precise, high-quality LASIK flaps:
Total flap procedure is typically
1
minute or less
Tunnels for Intracorneal Rings
Pockets for Presbyopia-Correcting Inlays
REFERENCES
References:
1.Alcon data on file, 2019.
2.Yeu E, Scoper S. Retrospective comparison of clinical outcomes associated with manual and femtosecond laser cataract surgery. Paper presented at: American Society of Cataract and Refractive Surgery–American Society of Ophthalmic Administrators Annual Meeting; May 5-9, 2017; Los Angeles, CA.
3.LenSx Laser System Operator’s Manual, Rev B. Alcon Laboratories, Inc. Published September 2017.
4.Kohnen T, Mathys L, Petermann K, Herrmann E, Mayer W, Shajari M. Update on the comparison of femtosecond laser-assisted lens surgery to conventional cataract surgery: a systematic review and meta-analysis. Paper presented at: 35th Congress of the European Society of Cataract and Refractive Surgeons; October 7-11, 2017; Lisbon, Portugal.
5.Kránitz K, Miháltz K, Sándor GL, Takacs A, Knorz MC, Nagy ZZ. Intraocular lens tilt and decentration measured by Scheimpflug camera following manual or femtosecond laser-created continuous circular capsulotomy. J Refract Surg. 2012;28(4):259–263. doi:10.3928/1081597X-20120309-01.
6.Ali MH, Ullah S, Javaid U, Javaid M, Jamal S, Butt NH. Comparison of characteristics of femtosecond laser-assisted anterior capsulotomy versus manual continuous curvilinear capsulorrhexis: a meta-analysis of 5-year results. J Pak Med Assoc. 2017;67(10):1574–1579.
7.Mastropasqua L, Toto L, Mastropasqua A, et al. Femtosecond laser versus manual clear corneal incision in cataract surgery. J Refract Surg. 2014;30(1):27–33. doi:10.3928/1081597X-20131217-03.
8.ClinicalTrials.gov. Bethesda, MD: US National Library of Medicine; 2015. http://clinicaltrials.gov/ct2/show/NCT02396719. Updated June 6, 2019. Accessed October 14, 2019.
9.Wang L, Zhang S, Zhang Z, et al. Femtosecond laser penetrating corneal relaxing incisions combined with cataract surgery. J Cataract Refract Surg. 2016;42(7):995–1002. doi:10.1016/j.jcrs.2016.04.020.
10.Toto L, Mastropasqua R, Mattei PA, et al. Postoperative IOL axial movements and refractive changes after femtosecond laser-assisted cataract surgery versus conventional phacoemulsification. J Refract Surg. 2015;31(8):524–530. doi:10.3928/1081597X-20150727-02.
11.Yeoh R. Practical differences between 3 femtosecond phaco laser platforms. J Cataract Refract Surg. 2014;40(3):510. doi:10.1016/j.jcrs.2014.01.018.
12.Chan T, Pattamatta U, Butlin M, Meades K, Bala C. Intereye comparison of femtosecond laser-assisted cataract surgery capsulotomy and manual capsulorhexis edge strength. J Cataract Refract Surg. 2017;43(4):480–485. doi:10.1016/j.jcrs.2016.12.033.
13.Roberts TV, Lawless M, Sutton G, Hodge C. Update and clinical utility of the LenSx femtosecond laser in cataract surgery. Clin Ophthalmol. 2016;10:2021–2029. doi:10.2147/OPTH.S94306.
14.Roberts TV, Lawless M, Sutton G, Hodge C. Anterior capsule integrity after femtosecond laser-assisted cataract surgery. J Cataract Refract Surg. 2015;41(5):1109–1110. doi:10.1016/j.jcrs.2014.11.044.
15.Nagy Z, Takacs A, Filkorn T, Sarayba M. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. J Refract Surg. 2009;25(12):1053–1060. doi:10.3928/1081597X-20091117-04.
16.Al-Mohtaseb Z, He X, Yesilirmak N, Waren D, Donaldson KE. Comparison of corneal endothelial cell loss between two femtosecond laser platforms and standard phacoemulsification. J Refract Surg. 2017;33(10):708–712. doi:10.3928/1081597X-20170731-01.
17.Chen X, Chen K, He J, Yao K. Comparing the curative effects between femtosecond laser-assisted cataract surgery and conventional phacoemulsification surgery: a meta-analysis. PLoS One. 2016;11(3):e0152088. doi:10.1371/journal.pone.0152088.
18.Bouchet, C, Dhariwal M, Wehler EA, et al. Comparing the efficacy, safety, and efficiency outcomes between LenSx femtosecond laser-assisted cataract surgery and phacoemulsification cataract surgery: a meta-analysis [abstract]. Value Health. 2017;20(9):A800–A801.
19.Tran DB, Vargas V, Potvin R. Neodymium:YAG capsulotomy rates associated with femtosecond laser-assisted versus manual cataract surgery. J Cataract Refract Surg. 2016;42(10):1470–1476. doi:10.1016/j.jcrs.2016.08.019.
20.Chen X, Yu Y, Song X, Zhu Y, Wang W, Yao K. Clinical outcomes of femtosecond laser-assisted cataract surgery versus conventional phacoemulsification surgery for hard nuclear cataracts. J Cataract Refract Surg. 2017;43(4):486–491. doi:10.1016/j.jcrs.2017.01.010.
21.Shajari M, Khalil S, Mayer WJ, et al. Comparison of 2 laser fragmentation patterns used in femtosecond laser-assisted cataract surgery. J Cataract Refract Surg. 2017;43(12):1571–1574. doi:10.1016/j.jcrs.2017.09.027.
22.Roberts H, Wagh VK, Mullens IJM, Borsci S, Ni MZ, O’Brart DPS. Evaluation of a hub-and-spoke model for the delivery of femtosecond laser-assisted cataract surgery within the context of a large randomised controlled trial [published online February 7, 2018]. Br J Ophthalmol. 2018;102(11):1556-1563. doi:10.1136/bjophthalmol-2017-311319.
23.Slade S, Ignacio T, Spector S. Evaluation of a multifunctional femtosecond laser for the creation of laser in situ keratomileusis
flaps. J Cataract Refract Surg. 2018;44(3):280–286. doi:10.1016/j.jcrs.2017.12.016.
24. Alcon data on file, 2015.
TAKE THE FIRST STEP IN CREATING REPRODUCIBLE OUTCOMES WITH THE
LENSX®LASER
4-9
2,3
1
8,9,11,12
8,9,11,12
13,14
3,7,15
4-6
11
11
12,13
14
1-3
1
2
21
10
10
10
1-3
23
4-6
7
10
8,
8,
8,
12
13,14
4,16,17
4,18
19
20
2,
2,
21
22
23
24
4,16,17
15,†
©2019 Alcon Inc. 11/19 US-LSX-1900012
important safety information
REferences
Pockets for Presbyopia-Correcting Inlays
Total flap procedure is typically
• Delivers consistent flap thickness and smooth edges
• Provides surgeon-selectable flap location, hinge, and side-cut parameters
• Creates a uniform bubble layer for easier lifting of the flap
• Helps minimize appearance of an opaque bubble layer
Tunnels for Intracorneal Rings
minute or less
Precise, high-quality LASIK flaps:
The LenSx®Laser has been enhanced to allow for more corneal applications
Added Versatility for Your Femtosecond Performance
1
Content Block 6
720 x 720
• Empowers efficient treatment for a variety of lens densities
• Significantly reduces phaco time and energy
Customize your approach to each patient with versatile fragmentation
Built for performance, built for speed
On average, laser cataract patients spend less time in the OR
Proven Efficiency
less mean postoperative astigmatism vs manual cases (0.32 D vs 0.65 D) §
of eyes fall within 0.5 D of target refraction vs 83.1% with manual
A greater proportion of eyes treated reach emmetropia (±0.5 D) than those treated with manual surgery
Content Block 5
720 x 720
The SoftFit®Patient Interface
Experience greater precision with the hydrogel lens insert of the LenSx®Laser
LEARN MORE ABOUT VERION®
of corneal incisions could be opened by a blunt spatula
97.6%
of fragmentations required no additional segmentation after the laser procedure
99.5%
More accurate, more efficient, and less damaging self-sealing cataract incision in terms of architecture, size and geometry
of anterior capsulotomies achieved without manual separation of residual tags
Less variability of anterior chamber depth with more stable post-op refraction
More precise, reproducible and reliable capsulotomies
Reproducibility and accuracy at every step
Proven Precision
98.6%
Get it right the first time
Versus manual procedures, LenSx®laser delivers:
Connectivity to the VERION®Image
Guided System delivers a new level of certainty
*Prospective, multicenter study investigated performance of FLACS at 1 month post-op in Chinese patients (n = 1542 eyes).
†Capsulotomy and phacofragmentation procedures were evaluated in porcine eyes (n = 8 for manual, n = 10 for LenSx®group).
‡Retrospective chart review of 225 patients for LenSx®and manual groups.
§Retrospective chart review of 231 patients for LenSx®and manual groups.
Faster
rehabilitation in hard cataracts, along with less phaco power and endothelial cell damage
Lower
rate of YAG capsulotomies
Improved
central corneal thickness at Day 1 for quieter eyes
Superior
endothelial cell retention at 1 and 3 months
LenSx®laser vs Manual Procedures
less phaco energy
less phaco time
<0.1%
capsular tear rate with SoftFit®Patient Interface
LenSx®capsulotomy
integrity
As strong as manual
<2 minutes
total time for patients under suction in cataract procedures
Proven Safety
Proven Outcomes
Proven Safety
Proven Efficiency
Proven Outcomes
The LenSx®Laser is Alcon’s clinically proven femtosecond platform that creates reproducible cataract outcomes
Proven Precision
TAKE THE FIRST STEP IN CREATING REPRODUCIBLE OUTCOMES WITH THE
LENSX®LASER
Trusted in more than 2 MILLION cataract procedures
Scroll to Learn More
Important Safety Information
4-9
4-6
7
10
8,
*
8,
*
8,
*
8,
*
2,3
1
8,9,11,12
8,9,11,12
13,14
3,7,15
4-6
11
12
13,14
4,16,17
15,
†
15,
†
4,18
19
20
11
12,13
14
1-3
1
2
‡
2,
2,
21
21
22
10
10
10
1-3
23
23
24
IMPORTANT SAFETY INFORMATION
LENSX® LASER IMPORTANT PRODUCT INFORMATION
FOR CATARACT SURGERY, CORNEAL FLAP AND CORNEAL POCKETS & TUNNEL INCISIONS
CAUTION: Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner.
INDICATIONS FOR THE LENSX® LASER:
CATARACT SURGERY INDICATION: In the creation of corneal cuts/incisions (single-plane, multi-plane and arcuate) anterior capsulotomy and laser phacofragmentation during cataract surgery in adult patients. Each of these procedures may be performed either individually or consecutively during the same surgery.
CORNEAL FLAP INDICATION: For use in the creation of a corneal flap in adult patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
CORNEAL POCKETS AND TUNNELS: In adult patients, for the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings.
RESTRICTIONS: Patients must be able to lie flat and motionless in a supine position. Patient must be able to understand and give an informed consent. Patients must be able to tolerate local or topical anesthesia. Patients with elevated IOP should use topical steroids only under close medical supervision.
CONTRAINDICATIONS
CATARACT SURGERY CONTRAINDICATIONS: Corneal disease that precludes applanation of the cornea or transmission of laser light at 1030 nm wavelength. Descemetocele with impending corneal rupture. Presence of blood or other material in the anterior chamber. Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy. Conditions which would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only). Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape. Corneal thickness requirements that are beyond the range of the system. Corneal opacity that would interfere with the laser beam, Hypotony, glaucoma* or the presence of a corneal implant. Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease). History of lens or zonular instability. Any contraindication to cataract or keratoplasty. This device is not intended for use in pediatric surgery.
*Glaucoma is not a contraindication when these procedures are performed using the LenSx® Laser SoftFit® Patient Interface Accessory
CORNEAL SURGERY (FLAPS, POCKETS, TUNNELS) CONTRAINDICATIONS: Corneal lesions. Corneal edema. Hypotony. Glaucoma. Existing corneal implant. Keratoconus. This device is not intended for use in pediatric surgery. Flap creation, tunnels, pockets and cataract procedures cannot be combined into a single treatment.
WARNINGS : The LenSx® Laser System should only be operated by a physician trained in its use. The LenSx® Laser delivery system employs one sterile disposable Patient Interface consisting of an applanation lens and suction ring. The Patient Interface is intended for single use only. Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards.
PRECAUTIONS: Do not use cell phones or pagers of any kind in the same room as the LenSx® Laser. Discard used Patient Interfaces as medical waste.
COMPLICATIONS
CATARACT SURGERY AES/COMPLICATIONS: Corneal edema. Capsulotomy, phacofragmentation, or cut or incision decentration. Incomplete or interrupted capsulotomy, fragmentation, or corneal incision procedure. Capsular tear. Corneal abrasion or defect. Pain. Infection. Bleeding. Damage to intraocular structures. Anterior chamber fluid leakage, anterior chamber collapse. Elevated pressure to the eye.
CORNEAL SURGERY (FLAPS, POCKETS & TUNNELS) AES/COMPLICATIONS: Corneal edema. Corneal or eye pain.V Corneal haze. Epithelial in-growth. Corneal abrasion or epithelial defect. Infection/keratitis. Corneal ectasia or endothelial perforation. Decentered flap or pattern; uneven flap bed. Incomplete dissection/inability to complete procedure. Flap tearing or incomplete lift-off. Free cap or buttonhole. Elevated pressure to the eye.
ATTENTION: Refer to the LenSx® Laser Operator’s Manual for a complete listing of indications, warnings and precautions.
VERION® IMAGE GUIDED SYSTEM IMPORTANT PRODUCT INFORMATION
VERION® REFERENCE UNIT AND VERION® DIGITAL MARKER
CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
INTENDED USES: The Verion® Reference Unit is a preoperative measurement device that captures and utilizes a high-resolution reference image of a patient’s eye. In addition, the Verion® Reference Unit provides pre-operative surgical planning functions to assist the surgeon with planning cataract surgical procedures. The Verion® Reference Unit also supports the export of the reference image, preoperative measurement data, and surgical plans for use with the Verion® Digital Marker and other compatible devices through the use of a USB memory stick. The Verion® Digital Marker links to compatible surgical microscopes to display concurrently the reference and microscope images, allowing the surgeon to account for lateral and rotational eye movements. In addition, details from the Verion® Reference Unit surgical plan can be overlaid on a computer screen or the physician’s microscope view.
CONTRAINDICATIONS: The following conditions may affect the accuracy of surgical plans prepared with the Verion® Reference Unit: a pseudophakic eye, eye fixation problems, a non-intact cornea, or an irregular cornea. In addition, patients should refrain from wearing contact lenses during the reference measurement as this may interfere with the accuracy of the measurements. The following conditions may affect the proper functioning of the Verion® Digital Marker: changes in a patient’s eye between preoperative measurement and surgery, an irregular elliptic limbus (e.g., due to eye fixation during surgery, and bleeding or bloated conjunctiva due to anesthesia). In addition, the use of eye drops that constrict sclera vessels before or during surgery should be avoided.
WARNINGS: Only properly trained personnel should operate the Verion® Reference Unit and Verion® Digital Marker. Use only the provided medical power supplies and data communication cable. Power supplies for the Verion® Reference Unit and the Verion® Digital Marker must be uninterruptible. Do not use these devices in combination with an extension cord. Do not cover any of the component devices while turned on. The Verion® Reference Unit uses infrared light. Unless necessary, medical personnel and patients should avoid direct eye exposure to the emitted or reflected beam.
PRECAUTIONS: To ensure the accuracy of Verion® Reference Unit measurements, device calibration and the reference measurement should be conducted in dimmed ambient light conditions. Only use the Verion® Digital Marker in conjunction with compatible surgical microscopes.
ATTENTION: Refer to the user manuals for the Verion® Reference Unit and the VerionH Digital Marker for a complete description of proper use and maintenance of these devices, as well as a complete list of contraindications, warnings and precautions.
REFERENCES
References:
1.Alcon data on file, 2019.
2.Yeu E, Scoper S. Retrospective comparison of clinical outcomes associated with manual and femtosecond laser cataract surgery. Paper presented at: American Society of Cataract and Refractive Surgery–American Society of Ophthalmic Administrators Annual Meeting; May 5-9, 2017; Los Angeles, CA.
3.LenSx Laser System Operator’s Manual, Rev B. Alcon Laboratories, Inc. Published September 2017.
4.Kohnen T, Mathys L, Petermann K, Herrmann E, Mayer W, Shajari M. Update on the comparison of femtosecond laser-assisted lens surgery to conventional cataract surgery: a systematic review and meta-analysis. Paper presented at: 35th Congress of the European Society of Cataract and Refractive Surgeons; October 7-11, 2017; Lisbon, Portugal.
5.Kránitz K, Miháltz K, Sándor GL, Takacs A, Knorz MC, Nagy ZZ. Intraocular lens tilt and decentration measured by Scheimpflug camera following manual or femtosecond laser-created continuous circular capsulotomy. J Refract Surg. 2012;28(4):259–263. doi:10.3928/1081597X-20120309-01.
6.Ali MH, Ullah S, Javaid U, Javaid M, Jamal S, Butt NH. Comparison of characteristics of femtosecond laser-assisted anterior capsulotomy versus manual continuous curvilinear capsulorrhexis: a meta-analysis of 5-year results. J Pak Med Assoc. 2017;67(10):1574–1579.
7.Mastropasqua L, Toto L, Mastropasqua A, et al. Femtosecond laser versus manual clear corneal incision in cataract surgery. J Refract Surg. 2014;30(1):27–33. doi:10.3928/1081597X-20131217-03.
8.ClinicalTrials.gov. Bethesda, MD: US National Library of Medicine; 2015. http://clinicaltrials.gov/ct2/show/NCT02396719. Updated June 6, 2019. Accessed October 14, 2019.
9.Wang L, Zhang S, Zhang Z, et al. Femtosecond laser penetrating corneal relaxing incisions combined with cataract surgery. J Cataract Refract Surg. 2016;42(7):995–1002. doi:10.1016/j.jcrs.2016.04.020.
10.Toto L, Mastropasqua R, Mattei PA, et al. Postoperative IOL axial movements and refractive changes after femtosecond laser-assisted cataract surgery versus conventional phacoemulsification. J Refract Surg. 2015;31(8):524–530. doi:10.3928/1081597X-20150727-02.
11.Yeoh R. Practical differences between 3 femtosecond phaco laser platforms. J Cataract Refract Surg. 2014;40(3):510. doi:10.1016/j.jcrs.2014.01.018.
12.Chan T, Pattamatta U, Butlin M, Meades K, Bala C. Intereye comparison of femtosecond laser-assisted cataract surgery capsulotomy and manual capsulorhexis edge strength. J Cataract Refract Surg. 2017;43(4):480–485. doi:10.1016/j.jcrs.2016.12.033.
13.Roberts TV, Lawless M, Sutton G, Hodge C. Update and clinical utility of the LenSx femtosecond laser in cataract surgery. Clin Ophthalmol. 2016;10:2021–2029. doi:10.2147/OPTH.S94306.
14.Roberts TV, Lawless M, Sutton G, Hodge C. Anterior capsule integrity after femtosecond laser-assisted cataract surgery. J Cataract Refract Surg. 2015;41(5):1109–1110. doi:10.1016/j.jcrs.2014.11.044.
15.Nagy Z, Takacs A, Filkorn T, Sarayba M. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. J Refract Surg. 2009;25(12):1053–1060. doi:10.3928/1081597X-20091117-04.
16.Al-Mohtaseb Z, He X, Yesilirmak N, Waren D, Donaldson KE. Comparison of corneal endothelial cell loss between two femtosecond laser platforms and standard phacoemulsification. J Refract Surg. 2017;33(10):708–712. doi:10.3928/1081597X-20170731-01.
17.Chen X, Chen K, He J, Yao K. Comparing the curative effects between femtosecond laser-assisted cataract surgery and conventional phacoemulsification surgery: a meta-analysis. PLoS One. 2016;11(3):e0152088. doi:10.1371/journal.pone.0152088.
18.Bouchet, C, Dhariwal M, Wehler EA, et al. Comparing the efficacy, safety, and efficiency outcomes between LenSx femtosecond laser-assisted cataract surgery and phacoemulsification cataract surgery: a meta-analysis [abstract]. Value Health. 2017;20(9):A800–A801.
19.Tran DB, Vargas V, Potvin R. Neodymium:YAG capsulotomy rates associated with femtosecond laser-assisted versus manual cataract surgery. J Cataract Refract Surg. 2016;42(10):1470–1476. doi:10.1016/j.jcrs.2016.08.019.
20.Chen X, Yu Y, Song X, Zhu Y, Wang W, Yao K. Clinical outcomes of femtosecond laser-assisted cataract surgery versus conventional phacoemulsification surgery for hard nuclear cataracts. J Cataract Refract Surg. 2017;43(4):486–491. doi:10.1016/j.jcrs.2017.01.010.
21.Shajari M, Khalil S, Mayer WJ, et al. Comparison of 2 laser fragmentation patterns used in femtosecond laser-assisted cataract surgery. J Cataract Refract Surg. 2017;43(12):1571–1574. doi:10.1016/j.jcrs.2017.09.027.
22.Roberts H, Wagh VK, Mullens IJM, Borsci S, Ni MZ, O’Brart DPS. Evaluation of a hub-and-spoke model for the delivery of femtosecond laser-assisted cataract surgery within the context of a large randomised controlled trial [published online February 7, 2018]. Br J Ophthalmol. 2018;102(11):1556-1563. doi:10.1136/bjophthalmol-2017-311319.
23.Slade S, Ignacio T, Spector S. Evaluation of a multifunctional femtosecond laser for the creation of laser in situ keratomileusis flaps. J Cataract Refract Surg. 2018;44(3):280–286. doi:10.1016/j.jcrs.2017.12.016.
24. Alcon data on file, 2015.
©2019 Alcon Inc. 11/19 US-LSX-1900012
important safety information
REferences
Pockets for Presbyopia-Correcting Inlays
Total flap procedure is typically
• Delivers consistent flap thickness and smooth edges
• Provides surgeon-selectable flap location, hinge, and side-cut parameters
• Creates a uniform bubble layer for easier lifting of the flap
• Helps minimize appearance of an opaque bubble layer
Tunnels for Intracorneal Rings
minute or less
Precise, high-quality LASIK flaps:
The LenSx®Laser has been enhanced to allow for more corneal applications
Added Versatility for Your Femtosecond Performance
1
Content Block 6
720 x 720
• Empowers efficient treatment for a variety of lens densities
• Significantly reduces phaco time and energy
Customize your approach to each patient with versatile fragmentation
Built for performance, built for speed
On average, laser cataract patients spend less time in the OR
Proven Efficiency
less mean postoperative astigmatism vs manual cases (0.32 D vs 0.65 D) §
of eyes fall within 0.5 D of target refraction vs 83.1% with manual
A greater proportion of eyes treated reach emmetropia (±0.5 D) than those treated with manual surgery
Content Block 5
720 x 720
The SoftFit®Patient Interface
Experience greater precision with the hydrogel lens insert of the LenSx®Laser
LEARN MORE ABOUT VERION®
of corneal incisions could be opened by a blunt spatula
97.6%
of fragmentations required no additional segmentation after the laser procedure
99.5%
More accurate, more efficient, and less damaging self-sealing cataract incision in terms of architecture, size and geometry
of anterior capsulotomies achieved without manual separation of residual tags
Less variability of anterior chamber depth with more stable post-op refraction
More precise, reproducible and reliable capsulotomies
Reproducibility and accuracy at every step
Proven Precision
98.6%
Get it right the first time
Versus manual procedures, LenSx®laser delivers:
Connectivity to the VERION®Image
Guided System delivers a new level of certainty
*Prospective, multicenter study investigated performance of FLACS at 1 month post-op in Chinese patients (n = 1542 eyes).
†Capsulotomy and phacofragmentation procedures were evaluated in porcine eyes (n = 8 for manual, n = 10 for LenSx®group).
‡Retrospective chart review of 225 patients for LenSx®and manual groups.
§Retrospective chart review of 231 patients for LenSx®and manual groups.
Faster
rehabilitation in hard cataracts, along with less phaco power and endothelial cell damage
Lower
rate of YAG capsulotomies
Improved
central corneal thickness at Day 1 for quieter eyes
Superior
endothelial cell retention at 1 and 3 months
LenSx®laser vs Manual Procedures
less phaco energy
less phaco time
<0.1%
capsular tear rate with SoftFit®Patient Interface
LenSx®
capsulotomy integrity
As strong as manual
<2 minutes
total time for patients under suction in cataract procedures
Proven Safety
Proven Outcomes
Proven Safety
Proven Efficiency
Proven Outcomes
The LenSx®Laser is Alcon’s clinically proven femtosecond platform that creates reproducible cataract outcomes
Proven Precision
TAKE THE FIRST STEP IN CREATING REPRODUCIBLE OUTCOMES WITH THE
LENSX®LASER
Trusted in more than 2 MILLION cataract procedures
Scroll to Learn More
Important Safety Information
4-9
4-6
7
10
8,*
8,*
8,*
2,3
1
8,9,11,12
8,9,11,12
13,14
3,7,15
4-6
11
12
13,14
4,16,17
15,†
15,†
4,18
19
20
11
12,13
14
1-3
1
2
2,
2,
21
21
22
10
10
10
1-3
23
23
24
IMPORTANT SAFETY INFORMATION
LENSX® LASER IMPORTANT PRODUCT INFORMATION
FOR CATARACT SURGERY, CORNEAL FLAP AND CORNEAL POCKETS & TUNNEL INCISIONS
CAUTION: Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner.
INDICATIONS FOR THE LENSX® LASER:
CATARACT SURGERY INDICATION: In the creation of corneal cuts/incisions (single-plane, multi-plane and arcuate) anterior capsulotomy and laser phacofragmentation during cataract surgery in adult patients. Each of these procedures may be performed either individually or consecutively during the same surgery.
CORNEAL FLAP INDICATION: For use in the creation of a corneal flap in adult patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
CORNEAL POCKETS AND TUNNELS: In adult patients, for the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings.
RESTRICTIONS: Patients must be able to lie flat and motionless in a supine position. Patient must be able to understand and give an informed consent. Patients must be able to tolerate local or topical anesthesia. Patients with elevated IOP should use topical steroids only under close medical supervision.
CONTRAINDICATIONS
CATARACT SURGERY CONTRAINDICATIONS: Corneal disease that precludes applanation of the cornea or transmission of laser light at 1030 nm wavelength. Descemetocele with impending corneal rupture. Presence of blood or other material in the anterior chamber. Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy. Conditions which would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only). Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape. Corneal thickness requirements that are beyond the range of the system. Corneal opacity that would interfere with the laser beam, Hypotony, glaucoma* or the presence of a corneal implant. Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease). History of lens or zonular instability. Any contraindication to cataract or keratoplasty. This device is not intended for use in pediatric surgery.
*Glaucoma is not a contraindication when these procedures are performed using the LenSx® Laser SoftFit® Patient Interface Accessory
CORNEAL SURGERY (FLAPS, POCKETS, TUNNELS) CONTRAINDICATIONS: Corneal lesions. Corneal edema. Hypotony. Glaucoma. Existing corneal implant. Keratoconus. This device is not intended for use in pediatric surgery. Flap creation, tunnels, pockets and cataract procedures cannot be combined into a single treatment.
WARNINGS : The LenSx® Laser System should only be operated by a physician trained in its use. The LenSx® Laser delivery system employs one sterile disposable Patient Interface consisting of an applanation lens and suction ring. The Patient Interface is intended for single use only. Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards.
PRECAUTIONS: Do not use cell phones or pagers of any kind in the same room as the LenSx® Laser. Discard used Patient Interfaces as medical waste.
COMPLICATIONS
CATARACT SURGERY AES/COMPLICATIONS: Corneal edema. Capsulotomy, phacofragmentation, or cut or incision decentration. Incomplete or interrupted capsulotomy, fragmentation, or corneal incision procedure. Capsular tear. Corneal abrasion or defect. Pain. Infection. Bleeding. Damage to intraocular structures. Anterior chamber fluid leakage, anterior chamber collapse. Elevated pressure to the eye.
CORNEAL SURGERY (FLAPS, POCKETS & TUNNELS) AES/COMPLICATIONS: Corneal edema. Corneal or eye pain.V Corneal haze. Epithelial in-growth. Corneal abrasion or epithelial defect. Infection/keratitis. Corneal ectasia or endothelial perforation. Decentered flap or pattern; uneven flap bed. Incomplete dissection/inability to complete procedure. Flap tearing or incomplete lift-off. Free cap or buttonhole. Elevated pressure to the eye.
ATTENTION: Refer to the LenSx® Laser Operator’s Manual for a complete listing of indications, warnings and precautions.
VERION® IMAGE GUIDED SYSTEM IMPORTANT PRODUCT INFORMATION
VERION® REFERENCE UNIT AND VERION® DIGITAL MARKER
CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
INTENDED USES: The Verion® Reference Unit is a preoperative measurement device that captures and utilizes a high-resolution reference image of a patient’s eye. In addition, the Verion® Reference Unit provides pre-operative surgical planning functions to assist the surgeon with planning cataract surgical procedures. The Verion® Reference Unit also supports the export of the reference image, preoperative measurement data, and surgical plans for use with the Verion® Digital Marker and other compatible devices through the use of a USB memory stick. The Verion® Digital Marker links to compatible surgical microscopes to display concurrently the reference and microscope images, allowing the surgeon to account for lateral and rotational eye movements. In addition, details from the Verion® Reference Unit surgical plan can be overlaid on a computer screen or the physician’s microscope view.
CONTRAINDICATIONS: The following conditions may affect the accuracy of surgical plans prepared with the Verion® Reference Unit: a pseudophakic eye, eye fixation problems, a non-intact cornea, or an irregular cornea. In addition, patients should refrain from wearing contact lenses during the reference measurement as this may interfere with the accuracy of the measurements. The following conditions may affect the proper functioning of the Verion® Digital Marker: changes in a patient’s eye between preoperative measurement and surgery, an irregular elliptic limbus (e.g., due to eye fixation during surgery, and bleeding or bloated conjunctiva due to anesthesia). In addition, the use of eye drops that constrict sclera vessels before or during surgery should be avoided.
WARNINGS: Only properly trained personnel should operate the Verion® Reference Unit and Verion® Digital Marker. Use only the provided medical power supplies and data communication cable. Power supplies for the Verion® Reference Unit and the Verion® Digital Marker must be uninterruptible. Do not use these devices in combination with an extension cord. Do not cover any of the component devices while turned on. The Verion® Reference Unit uses infrared light. Unless necessary, medical personnel and patients should avoid direct eye exposure to the emitted or reflected beam.
PRECAUTIONS: To ensure the accuracy of Verion® Reference Unit measurements, device calibration and the reference measurement should be conducted in dimmed ambient light conditions. Only use the Verion® Digital Marker in conjunction with compatible surgical microscopes.
ATTENTION: Refer to the user manuals for the Verion® Reference Unit and the VerionH Digital Marker for a complete description of proper use and maintenance of these devices, as well as a complete list of contraindications, warnings and precautions.
REFERENCES
References:
1.Alcon data on file, 2019.
2.Yeu E, Scoper S. Retrospective comparison of clinical outcomes associated with manual and femtosecond laser cataract surgery. Paper presented at: American Society of Cataract and Refractive Surgery–American Society of Ophthalmic Administrators Annual Meeting; May 5-9, 2017; Los Angeles, CA.
3.LenSx Laser System Operator’s Manual, Rev B. Alcon Laboratories, Inc. Published September 2017.
4.Kohnen T, Mathys L, Petermann K, Herrmann E, Mayer W, Shajari M. Update on the comparison of femtosecond laser-assisted lens surgery to conventional cataract surgery: a systematic review and meta-analysis. Paper presented at: 35th Congress of the European Society of Cataract and Refractive Surgeons; October 7-11, 2017; Lisbon, Portugal.
5.Kránitz K, Miháltz K, Sándor GL, Takacs A, Knorz MC, Nagy ZZ. Intraocular lens tilt and decentration measured by Scheimpflug camera following manual or femtosecond laser-created continuous circular capsulotomy. J Refract Surg. 2012;28(4):259–263. doi:10.3928/1081597X-20120309-01.
6.Ali MH, Ullah S, Javaid U, Javaid M, Jamal S, Butt NH. Comparison of characteristics of femtosecond laser-assisted anterior capsulotomy versus manual continuous curvilinear capsulorrhexis: a meta-analysis of 5-year results. J Pak Med Assoc. 2017;67(10):1574–1579.
7.Mastropasqua L, Toto L, Mastropasqua A, et al. Femtosecond laser versus manual clear corneal incision in cataract surgery. J Refract Surg. 2014;30(1):27–33. doi:10.3928/1081597X-20131217-03.
8.ClinicalTrials.gov. Bethesda, MD: US National Library of Medicine; 2015. http://clinicaltrials.gov/ct2/show/NCT02396719. Updated June 6, 2019. Accessed October 14, 2019.
9.Wang L, Zhang S, Zhang Z, et al. Femtosecond laser penetrating corneal relaxing incisions combined with cataract surgery. J Cataract Refract Surg. 2016;42(7):995–1002. doi:10.1016/j.jcrs.2016.04.020.
10.Toto L, Mastropasqua R, Mattei PA, et al. Postoperative IOL axial movements and refractive changes after femtosecond laser-assisted cataract surgery versus conventional phacoemulsification. J Refract Surg. 2015;31(8):524–530. doi:10.3928/1081597X-20150727-02.
11.Yeoh R. Practical differences between 3 femtosecond phaco laser platforms. J Cataract Refract Surg. 2014;40(3):510. doi:10.1016/j.jcrs.2014.01.018.
12.Chan T, Pattamatta U, Butlin M, Meades K, Bala C. Intereye comparison of femtosecond laser-assisted cataract surgery capsulotomy and manual capsulorhexis edge strength. J Cataract Refract Surg. 2017;43(4):480–485. doi:10.1016/j.jcrs.2016.12.033.
13.Roberts TV, Lawless M, Sutton G, Hodge C. Update and clinical utility of the LenSx femtosecond laser in cataract surgery. Clin Ophthalmol. 2016;10:2021–2029. doi:10.2147/OPTH.S94306.
14.Roberts TV, Lawless M, Sutton G, Hodge C. Anterior capsule integrity after femtosecond laser-assisted cataract surgery. J Cataract Refract Surg. 2015;41(5):1109–1110. doi:10.1016/j.jcrs.2014.11.044.
15.Nagy Z, Takacs A, Filkorn T, Sarayba M. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. J Refract Surg. 2009;25(12):1053–1060. doi:10.3928/1081597X-20091117-04.
16.Al-Mohtaseb Z, He X, Yesilirmak N, Waren D, Donaldson KE. Comparison of corneal endothelial cell loss between two femtosecond laser platforms and standard phacoemulsification. J Refract Surg. 2017;33(10):708–712. doi:10.3928/1081597X-20170731-01.
17.Chen X, Chen K, He J, Yao K. Comparing the curative effects between femtosecond laser-assisted cataract surgery and conventional phacoemulsification surgery: a meta-analysis. PLoS One. 2016;11(3):e0152088. doi:10.1371/journal.pone.0152088.
18.Bouchet, C, Dhariwal M, Wehler EA, et al. Comparing the efficacy, safety, and efficiency outcomes between LenSx femtosecond laser-assisted cataract surgery and phacoemulsification cataract surgery: a meta-analysis [abstract]. Value Health. 2017;20(9):A800–A801.
19.Tran DB, Vargas V, Potvin R. Neodymium:YAG capsulotomy rates associated with femtosecond laser-assisted versus manual cataract surgery. J Cataract Refract Surg. 2016;42(10):1470–1476. doi:10.1016/j.jcrs.2016.08.019.
20.Chen X, Yu Y, Song X, Zhu Y, Wang W, Yao K. Clinical outcomes of femtosecond laser-assisted cataract surgery versus conventional phacoemulsification surgery for hard nuclear cataracts. J Cataract Refract Surg. 2017;43(4):486–491. doi:10.1016/j.jcrs.2017.01.010.
21.Shajari M, Khalil S, Mayer WJ, et al. Comparison of 2 laser fragmentation patterns used in femtosecond laser-assisted cataract surgery. J Cataract Refract Surg. 2017;43(12):1571–1574. doi:10.1016/j.jcrs.2017.09.027.
22.Roberts H, Wagh VK, Mullens IJM, Borsci S, Ni MZ, O’Brart DPS. Evaluation of a hub-and-spoke model for the delivery of femtosecond laser-assisted cataract surgery within the context of a large randomised controlled trial [published online February 7, 2018]. Br J Ophthalmol. 2018;102(11):1556-1563. doi:10.1136/bjophthalmol-2017-311319.
23.Slade S, Ignacio T, Spector S. Evaluation of a multifunctional femtosecond laser for the creation of laser in situ keratomileusis flaps. J Cataract Refract Surg. 2018;44(3):280–286. doi:10.1016/j.jcrs.2017.12.016.
24. Alcon data on file, 2015.