Recall Z-1673-2009 ยท KYB Lens, Guide, Intraocular
Volk Optical Inc
Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures.
| Date | Jul 14, 2009 (initiated Jan 23, 2009) |
| Status | Terminated |
| 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 requi |
| Quantity | 3 units |
| Distribution | USA distribution to a single customer located in MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.