Recall Z-1093-04 ยท HQL Intraocular Lens
Bausch & Lomb Surgical, Inc.
SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens.
| Date | Jul 20, 2004 (initiated Feb 27, 2004) |
| Status | Terminated |
| Reason | Lens may be labeled with incorrect diopter size. |
| Root cause | Other |
| Action | The firm telephoned direct medical facility consginees on 2/27/2004 instructing to determine the disposition of the lenses and to return unimplanted ones. Follow-up phone calls were made in March 2004 for unresolved consignees. |
| Quantity | 36 |
| Distribution | Nationwide & puerto rico. FL, MA, CA, CT, MI, NY, IN, ID, GA, PA, IL, CO, TN, NC, PR, TX, ME and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.