Boston ES Rigid Gas Permeable Contact lens manufactured with Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lens M
FDA device recall Z-1705-2010 · posted 2010-05-27 · Terminated
Recall details
- Recalling firm
- Bausch & Lomb Inc
- Reason for recall
- The amount of D&C #6 Dye added to the formulation exceeded specified amounts.
- Action taken
- Bausch & Lomb issued an "Urgent Voluntary Medical Device Recall" notification dated April 20, 2010. Consignees were informed of the issue and asked to identify and return all affected product to the firm. For further information, contact Bausch & Lomb, Inc. at 1-585-338-5477.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HQD
- Quantity affected
- 2575 buttons
- Distribution
- Nationwide Distribution -- TX, IN and WI.
- Date initiated
- 2010-04-20
- Date posted
- 2010-05-27
- Date terminated
- 2016-04-27
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BOSTON(R) 7 - 30(ENFLUFOCON A) (K943177) | Polymer Technology Corp. | 1994-08-25 |