Z-0787-03

FreshLook Colors (phemfilcon A), 7-day Extended wear soft (hydrophilic) contact lens, Violet, SPH -0.75, Lot...

Name: Z-0787-03 FreshLook Colors (phemfilcon A), 7-day Extended wear soft (hydrophilic) contact lens, Violet, SPH -0.75, Lot...
Creator: Ciba Vision Corporation
Published: 2003-01-17
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2003-01-17 / Terminated / root cause: packaging

FDA source

Ciba Vision Corporation began a recall of FreshLook Colors (phemfilcon A), 7-day Extended wear soft (hydrophilic) contact lens, Violet, SPH -0.75, Lot 064429, 2006-11, BC: Median DIA: 14-5, Rx only... on 2003-01-17. The reason FDA records is "FreshLook 'Colors' contact lenses were incorrectly packaged into a FreshLook 'Colorblends' carton". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0787-03
Status: Terminated
Initiated: 2003-01-17
Posted: 2003-05-01
Terminated: 2003-05-01
Recalling firm: Alcon Laboratories
Product: FreshLook Colors (phemfilcon A), 7-day Extended wear soft (hydrophilic) contact lens, Violet, SPH -0.75, Lot 064429, 2006-11, BC: Median DIA: 14-5, Rx only, CIBA Vision Corp., Duluth, GA 30097, USA. The product was distributed in multi-packs (cartons of six lenses each).
Product code: LPM Lenses, Soft Contact, Extended Wear
Reason for recall: FreshLook 'Colors' contact lenses were incorrectly packaged into a FreshLook 'Colorblends' carton.
Root cause tag: packaging
FDA root cause: Other
Action: Consignees were notified via letter on January 17, 2003. They were advised to return any of the affected lot to CIBA Vision for replacement.
Quantity in commerce: 309/six pack cartons
Distribution: The product was distribured to wholesalers located in AL, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NJ, NY, OH, OK, OR, PA, TX, UT, WA, and WI.
Product codes and lots: Lot number 064429, Expiration 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)