Z-0741-04

FreshLook Colors, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH...

Name: Z-0741-04 FreshLook Colors, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH...
Creator: Ciba Vision Corporation
Published: 2004-03-11
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2004-03-11 / Terminated / root cause: labeling and UDI

FDA source

Ciba Vision Corporation began a recall of FreshLook Colors, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH ***, LOT ***, 2006-11, CIBA VISION Corporation, A... on 2004-03-11. The reason FDA records is "The lens inside the package does not match the prescription information labeled on the primary package". 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-0741-04
Status: Terminated
Initiated: 2004-03-11
Posted: 2004-07-20
Terminated: 2005-11-16
Recalling firm: Alcon Laboratories
Product: FreshLook Colors, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH ***, LOT ***, 2006-11, CIBA VISION Corporation, A Novartis Company, Duluth, GA 30007, USA, Made in USA.6-pack, 2 pack and single trial. Product is packed in 6 packs, 2 packs and single trial packs (Samples not for sale)
Product code: LPM Lenses, Soft Contact, Extended Wear
Reason for recall: The lens inside the package does not match the prescription information labeled on the primary package.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified by letter on 3/11/2004.
Quantity in commerce: 3141/6pk, 1000/2pk & 1720/single trial
Distribution: Nationwide, Canada, Latin America, South America, Germany, Thailand and South Africa.
Product codes and lots: Lot #067121, Exp. Date 2006-11, Lot #065047, Exp. Date 2006-11, Lot #065530, Exp. Date 2006-11, Lot #079803, Exp. Date 2003-08, Lot #065310, Exp. Date: 2006-11, Lot #0-65427, Exp. Date: 2006-11.

Product code LPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)