Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of diseases of the eye.
FDA device recall Z-1066-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Carl Zeiss Ophthalmic Systems Inc
- Reason for recall
- The coating of laser mirrors in a defined manufacturing lot of the Visulink 532/U devices may partially tear open and loosen from the base plate. The mirror may misdirect the laser beam to an unintended target in or on the eye. Retinal bleeding and burns may result.
- Action taken
- On June 3, 2004, the firm had contacted each of its consigness individually via phone, fax, or both.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 20
- Distribution
- The product was distributed directly to health professionals or hospitals.
- Date initiated
- 2004-06-03
- Date posted
- 2004-07-20
- Date terminated
- 2005-01-11
- Location
- Dublin, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VISULAS 532S (K013402) | Carl Zeiss, Inc. | 2001-11-14 |