Recall Z-0827-03 ยท LPL Lenses, Soft Contact, Daily Wear
Ciba Vision Corporation
Focus DAILIES Toric (nelfilcon), One-Day Contact Lenses, Daily Disposable (hydrophilic) soft contact lens, Rx only, Sterile, -1.50, -1.75 x 090, BC 8.6, DIA 14.2, CIBA Vision Corp., Duluth, GA 30097. USA. The product is packaged and distributed as 15 and 30 packs.
| Date | May 15, 2003 (initiated May 6, 2003) |
| Status | Terminated |
| Reason | Lenses may be labeled with the incorrect axis. |
| Root cause | Other |
| Action | Consignees were notified by letter via Airborne express mail on May 6, 2003. They were advised to return any of the affected lots remaining in their inventory to CIBA Vision, with the letter, a business reply form and a pre-paid air bill sticker provided by the recalling firm. |
| Quantity | 8, 572 packs (181, 440 lenses) |
| Distribution | The product was distributed to various wholesalers (original consignees) Nationwide, Canada and Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963487 | DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS Ciba Vision Corporation, Nov 27, 1996 |