Recall Z-2652-2010 ยท HQF Laser, Ophthalmic
Lumenis, Inc.
Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO
| Date | Sep 30, 2010 (initiated Jul 27, 2010) |
| Status | Terminated |
| Reason | Firm did not have proper 510(K) clearance. |
| Root cause | Component change control |
| Action | Lumenis sent letters to all customers on 7/27/10 instructing them to review their inventory, isolate affected product, complete a recall verification form and return all affected product to them. |
| Quantity | 250 probes (25 boxes, each containing 10 probes) |
| Distribution | FL, IL, MD, CO and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.