Recall Z-0787-03 ยท LPM Lenses, Soft Contact, Extended Wear
Ciba Vision Corporation
FreshLook Colors (phemfilcon A), 7-day Extended wear soft (hydrophilic) contact lens, Violet, SPH -0.75, Lot 064429, 2006-11, BC: Median DIA: 14-5, Rx only, CIBA Vision Corp., Duluth, GA 30097, USA. The product was distributed in multi-packs (cartons of six lenses each).
| Date | May 1, 2003 (initiated Jan 17, 2003) |
| Status | Terminated |
| Reason | FreshLook 'Colors' contact lenses were incorrectly packaged into a FreshLook 'Colorblends' carton. |
| Root cause | Other |
| Action | Consignees were notified via letter on January 17, 2003. They were advised to return any of the affected lot to CIBA Vision for replacement. |
| Quantity | 309/six pack cartons |
| Distribution | The product was distribured to wholesalers located in AL, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NJ, NY, OH, OK, OR, PA, TX, UT, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.