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U.S. Department of Health and Human Services

Class 3 Device Recall CIBA Vision

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  Class 3 Device Recall CIBA Vision see related information
Date Initiated by Firm May 06, 2003
Date Posted May 15, 2003
Recall Status1 Terminated 3 on November 18, 2003
Recall Number Z-0827-03
Recall Event ID 26221
510(K)Number K963487  
Product Classification Lenses, Soft Contact, Daily Wear - Product Code LPL
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Ciba Vision Corporation
11440 Johns Creek Parkway
Duluth GA 30097
For Additional Information Contact Customer Service Department
800-241-5999
Manufacturer Reason
for Recall		 Lenses may be labeled with the incorrect axis.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 8, 572 packs (181, 440 lenses)
Distribution The product was distributed to various wholesalers (original consignees) Nationwide, Canada and Europe.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LPL and Original Applicant = CIBA VISION CORPORATION
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