Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures.

FDA device recall Z-1673-2009 · posted 2009-07-14 · Terminated

Recall details

Recalling firm

Volk Optical Inc

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.

Action taken

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

Status

Terminated

Product code

KYB

Quantity affected

3 units

Distribution

USA distribution to a single customer located in MO.

Date initiated

2009-01-23

Date posted

2009-07-14

Date terminated

2012-04-12

Location

Mentor, OH