Z-0405-03

FreshLook, TORIC, for Astigmatism (phemfilcon A) Contact Lenses, BC Median, DIA 14.5, Lot 041599...

Name: Z-0405-03 FreshLook, TORIC, for Astigmatism (phemfilcon A) Contact Lenses, BC Median, DIA 14.5, Lot 041599...
Creator: Ciba Vision Corporation
Published: 2002-12-16
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2002-12-16 / Terminated / root cause: labeling and UDI

FDA source

Ciba Vision Corporation began a recall of FreshLook, TORIC, for Astigmatism (phemfilcon A) Contact Lenses, BC Median, DIA 14.5, Lot 041599, 2007-01Wesley Jessen Corporation, 333 E. Howard Avenue, Des... on 2002-12-16. The reason FDA records is "Mislabeling". 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-0405-03
Status: Terminated
Initiated: 2002-12-16
Posted: 2002-12-31
Terminated: 2003-08-07
Recalling firm: Alcon Laboratories
Product: FreshLook, TORIC, for Astigmatism (phemfilcon A) Contact Lenses, BC Median, DIA 14.5, Lot 041599, 2007-01Wesley Jessen Corporation, 333 E. Howard Avenue, Des Plains, IL 60018, USA, Made in USA, Sterile.
Product code: LPM Lenses, Soft Contact, Extended Wear
Reason for recall: Mislabeling
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Each customer was sent a recall letter via traceable mail on 12/16/02 with a Business Reply Form and a pre-paid air bill to return the product and completed form was attached. Customers who have not responded in 30 days will be contacted by telephone.
Quantity in commerce: 35 units (multi-pack/six lenses per unit).
Distribution: 01CA, FL, IL, IN, MA, MO, MS, OH, TX, UT, WI; Australia, Canada. There were no government accounts involved. CIBA Vision Canada, Ontario, Canada.
Product codes and lots: 049007 and 041599

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)