Sunsoft Multiples Toric, methafilcon A, clear contact lens.
FDA device recall Z-0348-05 · posted 2004-12-23 · Terminated
Recall details
- Recalling firm
- Ocular Sciences, Inc.
- Reason for recall
- Vials containing the lenses are possibly contaminated with residual hydrogen peroxide.
- Action taken
- All consignees were notified by courier on 12/09/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- LPL
- Quantity affected
- 46 lenses
- Distribution
- AR, AZ, CA, DC, GA, MI, MO, MS, NJ, NM, OR, PA, TN, TX, WI. No government, military or foreign distribution.
- Date initiated
- 2004-12-09
- Date posted
- 2004-12-23
- Date terminated
- 2005-03-31
- Location
- Albuquerque, NM
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS (K964696) | Sunsoft Corp. | 1997-02-20 |