Events

Recall of Device Recall MicroVisionMedical MicroScan Lense Disposable Plastic Cap

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Microvision Medical Holding B.V..

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
    35964
  • Event Risk Class
    Class 2
  • Event Number
    Z-1435-06
  • Event Initiated Date
    2006-07-21
  • Event Date Posted
    2006-08-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47272
  • 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
    Lens - Product Code FSO
  • Reason
    Some lenses may have microscopic holes in the disposable caps representing a potential break in the sterile barrier.
  • Action
    The recalling firm issued a recall letter dated 7/21/06 to their customers informing them of the problem and the need to return the product.

Device

Device Recall MicroVisionMedical MicroScan Lense Disposable Plastic Cap
  • Model / Serial
    Lot number 583546
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    World wide-The product was shipped to physicians in UT, IA, OR, MA, LA, CA. The product was also shipped to Germany, United Kingdom, and The Netherlands.
  • Product Description
    MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope, MicroVisionMedical brand
  • Manufacturer
    Microvision Medical Holding B.V.

Manufacturer

Microvision Medical Holding B.V.
  • Manufacturer Address
    Microvision Medical Holding B.V., Meibergdreef 45, Amsterdam Netherlands
  • Source
    USFDA