Recall Z-2292-2011 ยท HNO Keratome, Ac-Powered
Wavelight AG
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.
| Date | May 25, 2011 (initiated Apr 18, 2011) |
| Status | Terminated |
| Reason | The software calculating the patterns were found to has a rounding error for certain parameter ranges. These rounding errors could result in an incomplete cut in the donor or patient tissue. |
| Root cause | Other |
| Action | WaveLight AG sent an URGENT MEDICAL DEVICE CORRECTION letter April 18, 2011 to the affected customers. The letter identified the product, problem and the action to be taken by the customer. The letter advised the customers to discontinue keratoplasty cuts with the WaveLight FS200 until the new version can be installed. Alcon will contact you to schedule a visit of a service engineer at your site, to disable the keratoplasty function in your device, until a new software version can be installed to fix this problem. If you have experienced a product problem or adverse event related to this med |
| Quantity | 55 units |
| Distribution | Worldwide Distribution - USA including states of TX, KS, NC, CA, FL, OH, SC, MD, VA and NY and countries of Switzerland, Germany, Greece, United Kingdom, Ireland, Spain, Italy, Australia, India, Malaysia, France, Finland, Saudi Arabia, Czech Republic, Poland, China and South Korea and Iran. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101006 | WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 Alcon Research, Ltd., Oct 21, 2010 |