Recall Z-0923-04 ยท HQF Laser, Ophthalmic
Alcon Research, Ltd.
Opthalmic Laser, product number 8065-5000-1
| Date | Jul 20, 2004 (initiated Apr 9, 2004) |
| Status | Terminated |
| Reason | Product may generate laser light flashback. |
| Root cause | Other |
| Action | Additional in-service training materials have been prepared and will be delivered to users. Additional software upgrade will be made. Actvities will be complete in May 2004. |
| Quantity | 62 |
| Distribution | Nationwide and Sweden, Taiwan, Fiji Islands, Cyprus, Philippines. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.