Recall Z-1705-2010 ยท HQD Lens, Contact (Other Material) - Daily
Bausch & Lomb Inc
Boston ES Rigid Gas Permeable Contact lens manufactured with Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lens Material. Bausch & Lomb, Inc. Wilmington, MA 01887. Indicated for daily wear for the correction of refractive ametropia in aphakic and/or not-aphakic persons with non-diseased eyes.
| Date | May 27, 2010 (initiated Apr 20, 2010) |
| Status | Terminated |
| Reason | The amount of D&C #6 Dye added to the formulation exceeded specified amounts. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 2575 buttons |
| Distribution | Nationwide Distribution -- TX, IN and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943177 | BOSTON(R) 7 - 30(ENFLUFOCON A) Polymer Technology Corp., Aug 25, 1994 |