Z-0827-03

Focus DAILIES Toric (nelfilcon), One-Day Contact Lenses, Daily Disposable (hydrophilic) soft contact lens, Rx...

Name: Z-0827-03 Focus DAILIES Toric (nelfilcon), One-Day Contact Lenses, Daily Disposable (hydrophilic) soft contact lens, Rx...
Creator: Ciba Vision Corporation
Published: 2003-05-06
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2003-05-06 / Terminated / root cause: labeling and UDI

FDA source

Ciba Vision Corporation began a recall of 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... on 2003-05-06. The reason FDA records is "Lenses may be labeled with the incorrect axis". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0827-03
Status: Terminated
Initiated: 2003-05-06
Posted: 2003-05-15
Terminated: 2003-11-18
Recalling firm: Alcon Laboratories
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.
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: Lenses may be labeled with the incorrect axis.
Root cause tag: labeling and UDI
FDA 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 in commerce: 8, 572 packs (181, 440 lenses)
Distribution: The product was distributed to various wholesalers (original consignees) Nationwide, Canada and Europe.
Product codes and lots: 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.

Product code LPL

K963487Class IIDailies (Nelfilcon a) One-Day Soft Contact LensCiba Vision Corporation / cleared 1996-11-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)