Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended
FDA device recall Z-1685-2015 · posted 2015-05-28 · Terminated
Recall details
- Recalling firm
- Volk Optical Inc
- Reason for recall
- Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.
- Action taken
- 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 Coordinator. To return a recalled device(s) to Volk, please ask Volks RMA Coordinator for the appropriate Volk shipping account number (e.g., FedEx, UPS, etc.).
- Root cause
- Process control
- Status
- Terminated
- Product code
- HJK
- Quantity affected
- 6 units
- Distribution
- Worldwide Distribution - US Distribution to the states of : MA and VA., and to the countries of Mexico and Sweden.
- Date initiated
- 2015-02-27
- Date posted
- 2015-05-28
- Date terminated
- 2016-02-19
- Location
- Mentor, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONTACT LASER & DIAGNOSTIC LENSES (K023221) | Volk Optical, Inc. | 2002-10-11 |