FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1685-2015
- Recalling firm
- Volk Optical Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2015-02-27
- Posted
- 2015-05-28
- Terminated
- 2016-02-19
- 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 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.).
- Quantity
- 6 units
- Distribution
- Worldwide Distribution - US Distribution to the states of : MA and VA., and to the countries of Mexico and Sweden.
- Lot, serial or model codes
- Model #V25LC, Lot: BE09243
- 510(k) numbers
- ["K023221"]
- PMA numbers
- not on file
- Product code
- HJK
- Firm FEI
- 1000122772
- Firm city
- Mentor
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28