Recall Z-1685-2015 ยท HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Volk Optical Inc
Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
| Date | May 28, 2015 (initiated Feb 27, 2015) |
| Status | Terminated |
| Reason | Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. |
| Root cause | Process control |
| Action | Volk Optical, Inc, sent an Urgent Medical Device Recall letter dated March 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The Firm requests that you return the device(s) for replacement, at our cost. The recalled device(s) should be returned to Volk with an assigned Return Merchandise Authorization (RMA) number. Please contact Volk as soon as you receive this notification to setup a RMA for your device(s). Please contact Volk at (440) 942-6161 or toll-free at (800) 345-8655 to speak with a Volk RMA Coord |
| Quantity | 6 units |
| Distribution | Worldwide Distribution - US Distribution to the states of : MA and VA., and to the countries of Mexico and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023221 | CONTACT LASER & DIAGNOSTIC LENSES Volk Optical, Inc., Oct 11, 2002 |