Z-1673-2009

Optiflex Lens Positioning Unit (LPU)

Name: Z-1673-2009 Optiflex Lens Positioning Unit (LPU)
Creator: Volk Optical Inc
Published: 2009-01-23
License: https://open.fda.gov/license/

Volk Optical Inc / initiated 2009-01-23 / Terminated / root cause: manufacturing process

FDA source

Volk Optical Inc began a recall of Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures on 2009-01-23. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1673-2009
Status: Terminated
Initiated: 2009-01-23
Posted: 2009-07-14
Terminated: 2012-04-12
Recalling firm: Volk Optical Inc
Product: Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures.
Product code: KYB Lens, Guide, Intraocular
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.
Root cause tag: manufacturing process
FDA 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 required.
Quantity in commerce: 3 units
Distribution: USA distribution to a single customer located in MO.
Product codes and lots: Lot Number: CO44756

Product code KYB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)