FDA Medical Device Recalls (openFDA)
Coopervision Inc: Frequency 55 Toric (methafilcon B), flexible wear contact lenses (tinted). Responsible firms on the label: CooperVision ** Hamble, SO31 4RF, UK ** Scottsville, NY 14546.
- Recall number
- Z-1091-03
- 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.
- Status
- Terminated
- Initiated
- 2003-07-22
- Posted
- 2003-08-07
- Terminated
- 2004-02-13
- Reason
- Mislabeled with incorrect sphere power.
- Root cause
- Other
- Action
- Customers notified via telephone on 7/22/03.
- Quantity
- 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.
- Lot, serial or model codes
- 1468-212, Exp. 10/2008
- 510(k) numbers
- ["K962185"]
- PMA numbers
- ["P850079"]
- Product code
- LPL
- Firm FEI
- 1314956
- Firm city
- Scottsville
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28