SOFT CONTACT LENSES (toric) packaged under the following labels: (1) CV \ ENCORE toric (methafilcon A) and (2) ONEVUE 55
FDA device recall Z-0978-03 · posted 2003-07-03 · Terminated
Recall details
- Recalling firm
- Coopervision Inc
- Reason for recall
- The actual sphere power of the lens is lower than the labeled value.
- Action taken
- Letters dated June 24, 2003 issued to eye care practitioners and distributors with instructions to return lenses to Coopervision. Distributors also instructed to notify their customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- LPL
- Quantity affected
- 23,762 6-packs / 76,748 singles (trial lenses)
- Distribution
- Coopervision, Scottsville, NY is recalling from domestic customers nationwide. Product in Canada and Europe being recalled by affiliate in Europe.
- Date initiated
- 2003-06-25
- Date posted
- 2003-07-03
- Date terminated
- 2005-04-11
- 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 |
|---|---|---|
| FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (K973063) | Aspect Vision Care, Ltd. | 1997-08-26 |