Z-1091-03

Frequency 55 Toric (methafilcon B), flexible wear contact lenses (tinted). Responsible firms on the label...

Name: Z-1091-03 Frequency 55 Toric (methafilcon B), flexible wear contact lenses (tinted). Responsible firms on the label...
Creator: Coopervision Inc
Published: 2003-07-22
License: https://open.fda.gov/license/

CooperVision, Inc. / initiated 2003-07-22 / Terminated / root cause: labeling and UDI

FDA source

Coopervision Inc began a recall of Frequency 55 Toric (methafilcon B), flexible wear contact lenses (tinted). Responsible firms on the label: CooperVision ** Hamble, SO31 4RF, UK ** Scottsville... on 2003-07-22. The reason FDA records is "Mislabeled with incorrect sphere power". 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-1091-03
Status: Terminated
Initiated: 2003-07-22
Posted: 2003-08-07
Terminated: 2004-02-13
Recalling firm: CooperVision, Inc.
Product: Frequency 55 Toric (methafilcon B), flexible wear contact lenses (tinted). Responsible firms on the label: CooperVision ** Hamble, SO31 4RF, UK ** Scottsville, NY 14546.
Product code: LPL Lenses, Soft Contact, Daily Wear
Reason for recall: Mislabeled with incorrect sphere power.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Customers notified via telephone on 7/22/03.
Quantity in commerce: 152 lenses
Distribution: Nationwide. 33 eye care practitioners in the following states: AR, AL, CA, DE, FL, GA, IA, KS, MI, MA, NJ, NY, NC, OH, OK, PA, TX, UT, VA, and WI. Lenses were also shipped to Coopervision affiliates in the United Kingdom and Canada.
Product codes and lots: 1468-212, Exp. 10/2008

Product code LPL

K962185Class IIHydrasoft (East) and Hydrasoft Toric(east) (Methafilcon B) Daily Wear Soft Hydrophilic Contact LensCooperVision, Inc. / cleared 1996-12-17

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)