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
Recall
- Recall Number
- Z-1177-2016
- Event Number
- 73213
- Firm
- Volk Optical Inc
- FEI Number
- 1000122772
- Product Code
- HJK
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- February 2, 2016
- Posted
- March 15, 2016
- Terminated
- April 26, 2017
- Address
- 7893 Enterprise Dr, Mentor, OH, 44060-5309
Description
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
The firm discovered that the incorrect lot number was engraved on the product.
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 contact Volk at (440) 942-6161 or toll free at (800) 345-8655 as soon as they receive the notification to setup a RMA for their device(s). Customers were instructed to complete and return the enclosed response form as soon as possible. Customers with questions should call (440) 510-0745.
Worldwide Distribution - US (Virginia only) Internationally to Canada, France & Indonesia.
9 lens