FDA Recall
Terminated
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.
Recall: Z-0827-03
·
Initiated May 6, 2003
Recall
- Recall Number
- Z-0827-03
- Event Number
- 26221
- Firm
- Ciba Vision Corporation
- FEI Number
- 1053053
- Product Code
- LPL
- Status
- Terminated
- Root Cause
- Other
- Initiated
- May 6, 2003
- Posted
- May 15, 2003
- Terminated
- November 18, 2003
- Address
- 11440 Johns Creek Parkway, Duluth, GA, 30097
Description
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.
Reason
Lenses may be labeled with the incorrect axis.
Action
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.
Distribution
The product was distributed to various wholesalers (original consignees) Nationwide, Canada and Europe.
Quantity
8, 572 packs (181, 440 lenses)