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.
FDA Recall Z-0827-03 · Posted 2003-05-15
Advertisement
Recalling FirmCiba Vision Corporation
Recall StatusTerminated
Product CodeLPL
Date Initiated2003-05-06
Date Terminated2003-11-18
Product Quantity8, 572 packs (181, 440 lenses)
Reason for Recall
Lenses may be labeled with the incorrect axis.
Firm 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.
Root Cause
Other
Distribution Pattern
The product was distributed to various wholesalers (original consignees) Nationwide, Canada and Europe.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement