Events

Recall of MicroSTAAR Injector Cartridges Models: || SFC-25 (utilized with plate haptic Collamer lens) || MTC-60 (utilized with plate haptic Silicone lens)

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
    28070
  • Event Risk Class
    Class 2
  • Event Number
    Z-0378-04
  • Event Initiated Date
    2004-01-06
  • Event Date Posted
    2004-01-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31145
  • 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, Guide, Intraocular - Product Code KYB
  • Reason
    Increased numbers of lens tears during placement of lens into eye.
  • Action
    Customers will recieve recall notice, Customer Bulletin and MicroStaar Injector Cartridge Guide by Federal Espress (sent 1/6/04).

Device

MicroSTAAR Injector Cartridges Models: || SFC-25 (utilized with plate haptic Collamer lens) || MT...
  • Model / Serial
    SFC-25 (8 lots) 1180608, 1181078, 1181170,1181171, 1181396, 1181397, 1182237, 1184864 MTC-60 (25 lots) 1177222, 1177950, 1178121, 1178212, 1176868, 1177421, 1178738, 1178883, 1178885, 1179023, 1181789, 1181790, 1181797, 1181798, 1181980, 1182245, 1182342, 1182343, 1182344, 1182345, 1182675, 1182676, 1182677, 1182761.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada and Australia
  • Product Description
    MicroSTAAR Injector Cartridges Models: || SFC-25 (utilized with plate haptic Collamer lens) || MTC-60 (utilized with plate haptic Silicone lens)
  • Manufacturer
    Staar Surgical Co Inc

Manufacturer

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