Atlas FDA

FreshLook, TORIC, for Astigmatism (phemfilcon A) Contact Lenses, BC Median, DIA 14.5, Lot 041599, 2007-01Wesley Jessen C

FDA device recall Z-0405-03 · posted 2002-12-31 · Terminated

Recall details

Recalling firm
Ciba Vision Corporation
Reason for recall
Mislabeling
Action taken
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.
Root cause
Other
Status
Terminated
Product code
LPM
Quantity affected
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.
Date initiated
2002-12-16
Date posted
2002-12-31
Date terminated
2003-08-07
Location
Duluth, GA

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