Date Initiated by Firm | January 23, 2009 |
Date Posted | July 14, 2009 |
Recall Status1 |
Terminated 3 on April 12, 2012 |
Recall Number | Z-1673-2009 |
Recall Event ID |
52461 |
Product Classification |
ophthalmic surgical device - Product Code KYB
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Product | Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures. |
Code Information |
Lot Number: CO44756 |
Recalling Firm/ Manufacturer |
Volk Optical Inc 7893 Enterprise Dr Mentor OH 44060-5309
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For Additional Information Contact | 440-942-6161 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 3 units |
Distribution | USA distribution to a single customer located in MO. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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