Events

Recall of Device Recall lens positioning Unit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Volk Optical Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52461
  • Event Risk Class
    Class 2
  • Event Number
    Z-1673-2009
  • Event Initiated Date
    2009-01-23
  • Event Date Posted
    2009-07-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83084
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    ophthalmic surgical device - Product Code KYB
  • Reason
    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
    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.

Device

Device Recall lens positioning Unit
  • Model / Serial
    Lot Number: CO44756
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA distribution to a single customer located in MO.
  • Product Description
    Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures.
  • Manufacturer
    Volk Optical Inc

Manufacturer

Volk Optical Inc
  • Manufacturer Address
    Volk Optical Inc, 7893 Enterprise Dr, Mentor OH 44060-5309
  • Manufacturer Parent Company (2017)
    Halma Plc
  • Source
    USFDA