Recall Z-0348-03 ยท LPM Lenses, Soft Contact, Extended Wear
Bausch & Lomb Inc
OPTIMA FW (polymacon) Visibility Tinted Contact Lenses, labeled as -2.25D, 8.7 mm. Responsible firm on the label: Bausch & Lomb Inc., Rochester, NY 14692. Each box contains six lenses.
| Date | Dec 19, 2002 (initiated Nov 26, 2002) |
| Status | Terminated |
| Reason | Lenses labeled as -2.25 diopter contain -0.75 diopter lenses. |
| Root cause | Other |
| Action | Letters dated 12/2/02 issued to distributors and practitioners requesting return of the affected lot. |
| Quantity | 2,081 / 6-packs |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.