Events

Recall of STAAR Phaco Tubing Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Staar Surgical Co 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
    31653
  • Event Risk Class
    Class 2
  • Event Number
    Z-0775-05
  • Event Initiated Date
    2005-03-28
  • Event Date Posted
    2005-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38300
  • 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
    Gauze/Sponge, Internal, X-Ray Detectable - Product Code GDY
  • Reason
    Complaints of leaking with question of sterility and risk of infection in eye.
  • Action
    Recall was conducted by telephone and letter delivered by FEDEX on April 7, 2004. All consignees have been contacted.

Device

STAAR Phaco Tubing Kit

Manufacturer

Staar Surgical Co Inc
  • Manufacturer Address
    Staar Surgical Co Inc, 1911 Walker Ave, Monrovia CA 91016-4846
  • Source
    USFDA