Aug

2011

Cl ll WaveLight FS200 Femtosecond Laser System

Company:WaveLight AG
Date of Enforcement Report 8/3/11
Class ll:

PRODUCT
WaveLight FS200 Femtosecond Laser System Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2. The WaveLight FS 200 Laser System is an ophthalmic surgical laser indicated for use in refractive surgery for LASIK flap cutting, lamellar and perforating keratoplasty, and intrastromal surgery for implants. Recall # Z-2292-2011.

REASON
The software calculating the patterns were found to have a rounding error for certain parameter ranges. These rounding errors could result in an incomplete cut in the donor or patient tissue.

RECALLING FIRM/MANUFACTURER
WaveLight AG, Pressath, Germany, by letter April 18, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
55 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl ll WaveLight FS200 Femtosecond Laser System

Amy Sellers

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