Recall Z-1066-04 ยท GEX Powered Laser Surgical Instrument
Carl Zeiss Ophthalmic Systems Inc
Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of diseases of the eye.
| Date | Jul 20, 2004 (initiated Jun 3, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | On June 3, 2004, the firm had contacted each of its consigness individually via phone, fax, or both. |
| Quantity | 20 |
| Distribution | The product was distributed directly to health professionals or hospitals. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013402 | VISULAS 532S Carl Zeiss, Inc., Nov 14, 2001 |