Recall Z-0741-04 ยท LPM Lenses, Soft Contact, Extended Wear
Ciba Vision Corporation
FreshLook Colors, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH ***, LOT ***, 2006-11, CIBA VISION Corporation, A Novartis Company, Duluth, GA 30007, USA, Made in USA.6-pack, 2 pack and single trial. Product is packed in 6 packs, 2 packs and single trial packs (Samples not for sale)
| Date | Jul 20, 2004 (initiated Mar 11, 2004) |
| Status | Terminated |
| Reason | The lens inside the package does not match the prescription information labeled on the primary package. |
| Root cause | Other |
| Action | Consignees were notified by letter on 3/11/2004. |
| Quantity | 3141/6pk, 1000/2pk & 1720/single trial |
| Distribution | Nationwide, Canada, Latin America, South America, Germany, Thailand and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.