Recall Z-0703-03 ยท LPL Lenses, Soft Contact, Daily Wear
Ciba Vision Corporation
Glitter Eyes (tefilcon), daily wear soft (hydrophilic) contact lenses packed as single units or kits in mulitple glass vials.
| Date | Apr 1, 2003 (initiated Mar 17, 2003) |
| Status | Terminated |
| Reason | The lens may partially 'delaminate' in the area of one of the encapsulated cosmetic prints. |
| Root cause | Other |
| Action | The recall is being conducted to the wholesale level. The firm began contacting consignees via traceable mail on/about 3/17/2003. Included was A Business Reply Form and pre-paid airbill to return the product currently in inventory and the completed form. All inventory and returned product will be destroyed. |
| Quantity | 29,821 units |
| Distribution | Nationwide, Canada and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003071 | GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR Ciba Vision Corporation, Dec 13, 2000 |