Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures.
FDA Recall Z-1673-2009 · Posted 2009-07-14
Recalling FirmVolk Optical Inc
Recall StatusTerminated
Product CodeKYB
Date Initiated2009-01-23
Date Terminated2012-04-12
Product Quantity3 units
Reason for Recall
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.
Firm 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.
Root Cause
Process design
Distribution Pattern
USA distribution to a single customer located in MO.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.