Recall Z-0544-05 ยท LPL Lenses, Soft Contact, Daily Wear
Bausch & Lomb Inc
SofLens 66 Toric Visibility Tinted Contact Lenses for Daily Wear, sold in cartons containing 6 lenses each. Cartons/blister packs are labeled with -3.25 DS, -1.25DC, 170 degree Axis. Firm on label: Manufactured by Bausch & Lomb, Waterford, Ireland.
| Date | Feb 16, 2005 (initiated Feb 4, 2005) |
| Status | Terminated |
| Reason | Portion of lot contains lenses with incorrect refractive power. |
| Root cause | Other |
| Action | Letters issued dated February 4, 2005. The letters are flagged 'URGENT MEDICAL DEVICE RECALL'. Distributors are instructed to notify their customers to the retail (practitioner) level. All customers are instructed to return product. |
| Quantity | 798 cartons distrib. by B&L, Rochester, NY |
| Distribution | There are 134 eye care practitioners, 191 mass retailers, 19 distributors, 14 consumers, and 3 mail order businesses. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.