Focus DAILIES Toric (nelfilcon), One-Day Contact Lenses, Daily Disposable (hydrophilic) soft contact lens, Rx only, Sterile, -1.50, -1.75 x 090, BC 8.6, DIA 14.2, CIBA Vision Corp., Duluth, GA 30097. USA. The product is packaged and distributed as 15 and 30 packs.
- Company
- Ciba Vision Corporation
- Recall Initiated
- May 6, 2003
- Posted
- May 15, 2003
- Terminated
- November 18, 2003
- Recall Number
- Z-0827-03
- Quantity
- 8, 572 packs (181, 440 lenses)
- Firm Location
- Duluth, GA
Reason for Recall
Lenses may be labeled with the incorrect axis.
Distribution
The product was distributed to various wholesalers (original consignees) Nationwide, Canada and Europe.
Lot / Code Info
Focus Dailies Toric 15 lens pack (Cylinder 10.75/Axis 90¿¿): Sphere -1.00, Lot 2298508; Sphere 1.25, Lot #2298512, 2304513; Sphere -1.50, Lot #2298509, 2304510; Sphere -1.75, Lot #2304512, 2304522 and Sphere -2.00, Lot #2298510. Focus Dailies Toric 30 lens pack (Cylinder -0.75/Axis 90¿¿): Sphere -1.00, Lot #2298475, 2295481, 2298497, 2304509, 2304519, 2304529; Sphere -1.25, Lot #2298480, 2298485, 2298502, 2304523, 2304533; Sphere -1.50, Lot #2298476, 2298482, 2298498, 2304520, 2304530; Sphere -1.75, Lot #2298479, 2298484, 2298501, 2298511, 2304532 and Sphere -2.00, Lot #2298478, 2298483, 2298499, 2304511, 2304521, 2304531.
Root Cause
Other
Action Taken
Consignees were notified by letter via Airborne express mail on May 6, 2003. They were advised to return any of the affected lots remaining in their inventory to CIBA Vision, with the letter, a business reply form and a pre-paid air bill sticker provided by the recalling firm.