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U.S. Department of Health and Human Services

Class 2 Device Recall lens positioning Unit

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  Class 2 Device Recall lens positioning Unit see related information
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
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
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
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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