FDA Medical Device Recalls (openFDA)
Ciba Vision Corporation: 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 number
- Z-0827-03
- Recalling firm
- Ciba Vision Corporation
- 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.
- Status
- Terminated
- Initiated
- 2003-05-06
- Posted
- 2003-05-15
- Terminated
- 2003-11-18
- Reason
- Lenses may be labeled with the incorrect axis.
- Root cause
- 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
- 8, 572 packs (181, 440 lenses)
- Distribution
- The product was distributed to various wholesalers (original consignees) Nationwide, Canada and Europe.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K963487"]
- PMA numbers
- not on file
- Product code
- LPL
- Firm FEI
- 1053053
- Firm city
- Duluth
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28