Recall Z-0405-03 ยท LPM Lenses, Soft Contact, Extended Wear
Ciba Vision Corporation
FreshLook, TORIC, for Astigmatism (phemfilcon A) Contact Lenses, BC Median, DIA 14.5, Lot 041599, 2007-01Wesley Jessen Corporation, 333 E. Howard Avenue, Des Plains, IL 60018, USA, Made in USA, Sterile.
| Date | Dec 31, 2002 (initiated Dec 16, 2002) |
| Status | Terminated |
| Reason | Mislabeling |
| Root cause | Other |
| Action | Each customer was sent a recall letter via traceable mail on 12/16/02 with a Business Reply Form and a pre-paid air bill to return the product and completed form was attached. Customers who have not responded in 30 days will be contacted by telephone. |
| Quantity | 35 units (multi-pack/six lenses per unit). |
| Distribution | 01CA, FL, IL, IN, MA, MO, MS, OH, TX, UT, WI; Australia, Canada. There were no government accounts involved. CIBA Vision Canada, Ontario, Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.