Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye exa

FDA device recall Z-1177-2016 · posted 2016-03-15 · Terminated

Recall details

Recalling firm

Volk Optical Inc

Reason for recall

The firm discovered that the incorrect lot number was engraved on the product.

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

HJK

Quantity affected

9 lens

Distribution

Worldwide Distribution - US (Virginia only) Internationally to Canada, France & Indonesia.

Date initiated

2016-02-02

Date posted

2016-03-15

Date terminated

2017-04-26

Location

Mentor, OH