Frequency 55 Toric (methafilcon B), flexible wear contact lenses (tinted). Responsible firms on the label: CooperVision
FDA device recall Z-1091-03 · posted 2003-08-07 · Terminated
Recall details
- Recalling firm
- Coopervision Inc
- Reason for recall
- Mislabeled with incorrect sphere power.
- Action taken
- Customers notified via telephone on 7/22/03.
- Root cause
- Other
- Status
- Terminated
- Product code
- LPL
- Quantity affected
- 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 i
- Date initiated
- 2003-07-22
- Date posted
- 2003-08-07
- Date terminated
- 2004-02-13
- Location
- Scottsville, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS (K962185) | CooperVision, Inc. | 1996-12-17 |