FDA Medical Device Recalls (openFDA)
Volk Optical Inc: Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures.
- Recall number
- Z-1673-2009
- Recalling firm
- Volk Optical Inc
- Product
- Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures.
- Status
- Terminated
- Initiated
- 2009-01-23
- Posted
- 2009-07-14
- Terminated
- 2012-04-12
- Reason
- Lens may fall onto eye surface during procedure. Ophthalmologic device had a loose set screw on the Ball-Seal bushing assembly. As a result, the set screw becomes disengaged from the set screw groove in the bushing assembly and the Lens Positioning Unit slides downward.
- Root cause
- Process design
- Action
- Volk Optical sent a 'MEDICAL DEVICE RECALL' letter to their sole customer on 1/23/2009. The letter requests the return of the remaining two (2) units in the customer's possession (this firm experienced the device failure and reported the consumer complaint which prompted the recall; and had already returned the affected unit to the Volk for refund or replacement). The letter provides Volk's Fedex and UPS numbers for the customer to use to return the recalled units and also provides the E-mail address for the firm's contact person concerning this recall should additional assistance be required.
- Quantity
- 3 units
- Distribution
- USA distribution to a single customer located in MO.
- Lot, serial or model codes
- Lot Number: CO44756
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KYB
- 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