Events

Recall of Device Recall Venus Eye Sphere 18 mm (sterile)

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

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
    25123
  • Event Risk Class
    Class 2
  • Event Number
    Z-0531-03
  • Event Initiated Date
    2002-11-29
  • Event Date Posted
    2003-02-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25240
  • 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
    Implant, Orbital, Extra-Ocular - Product Code HQX
  • Reason
    Lack of sterility assurance.
  • Action
    The recalling firm issued letters to the accounts requesting the return of the devices.

Device

Device Recall Venus Eye Sphere 18 mm (sterile)
  • Model / Serial
    model number 14154. lot number 8447
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand
  • Product Description
    Venus Eye Sphere 18 mm (Sterile)
  • Manufacturer
    Gulden Ophthalmics

Manufacturer

Gulden Ophthalmics
  • Manufacturer Address
    Gulden Ophthalmics, 225 Cadwalader Ave, Elkins Park PA 19027-2020
  • Source
    USFDA