Recall Z-1313-04 ยท LPL Lenses, Soft Contact, Daily Wear
The Contact Lens Store, Inc.
Private Eyes, Diam 14.0 BC 8.6, Contents: one sterile daily wear soft contact lenses, 38% water, 62% polymacon, immersed in 0.9% buffered saline solution USP, Manufactured by Soft Lens Technology, Lot BB43 Expiration Date 08/06, Cosmetic Use Daily Wear ***Decorative Theatrical Contact Lenses, packed in vials labeled sterile. Types include: Zombie, Banshee, Green Leaf, Green Reptile, White Cat, Man
| Date | Aug 5, 2004 (initiated Jun 7, 2004) |
| Status | Terminated |
| Reason | The contact lenses were repacked in vials that were not sterile as indicated on the vial labeling. |
| Root cause | Other |
| Action | Consignees were first contacted by telephone with a f/u letter sent 6/7/2004 |
| Quantity | 618 vials |
| Distribution | MA, TX, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.