Recall Z-1177-2016 ยท HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Volk Optical Inc
Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities
| Date | Mar 15, 2016 (initiated Feb 2, 2016) |
| Status | Terminated |
| Reason | The firm discovered that the incorrect lot number was engraved on the product. |
| Root cause | Employee error |
| Action | Volk Optical sent an Urgent Medical Device Recall letter dated February 4, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and quarantine any affected product. Also, if product was further distributed customers should identify their customers and notify them at once of the product recall and include a copy of the letter. The affected devices should be returned to Volk with an assigned Return Merchandise Authorization (RMA) number. Customers should |
| Quantity | 9 lens |
| Distribution | Worldwide Distribution - US (Virginia only) Internationally to Canada, France & Indonesia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.