Recall Z-0793-2007 ยท LPL Lenses, Soft Contact, Daily Wear
Ciba Vision Corporation
CIBASoft Visitint Soft Contact Lenses, SKU #749591001385, Power -6.50, Diameter 13.8, Base Curve, 8.9, Expiration 2011-10.
| Date | May 9, 2007 (initiated Apr 30, 2007) |
| Status | Terminated |
| Reason | Base curve of the lenses do not meet specification. |
| Root cause | Other |
| Action | Consignees were contacted via traceable mail on 4/30/2007. The initial notification was sent to Eye Care Professionals. The firm subsequently identified one distributor and one retailer. The recall letter was revised and sent to these consignees on May 2, 2007. Specific return instructions were attached along with a Recall Tracking Form that was to be completed and returned to CIBA Vision. They were instructed to return any of the affected product on hand to CIBA Vision for replacement. |
| Quantity | 22 lenses |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.