WaveLight FS200 Femtosecond Laser System Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Bl
FDA device recall Z-2292-2011 · posted 2011-05-25 · Terminated
Recall details
- Recalling firm
- Wavelight AG
- Reason for recall
- 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.
- Action taken
- 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 medical device correction, please contact Alcon Medical Safety at 1-800-561-6466, option 3. Customers were requested to complete the attached reply form to acknowledge receipt of this notification and fax it to ( 817) 916-9087.
- Root cause
- Other
- Status
- Terminated
- Product code
- HNO
- Quantity affected
- 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, Malay
- Date initiated
- 2011-04-18
- Date posted
- 2011-05-25
- Date terminated
- 2011-09-23
- Location
- Pressath, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 (K101006) | Alcon Research, Ltd. | 2010-10-21 |