Events

Recall of Device Recall STAAR AQ CartridgeFP

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

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
    74067
  • Event Risk Class
    Class 2
  • Event Number
    Z-1964-2016
  • Event Initiated Date
    2016-05-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146155
  • 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
    The staar aq cartridge-fp may malfunction and may crack during loading or delivery of the iol (intraocular lenses).
  • Action
    STAAR sent a Medical Device Recall Letter dated May 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. STAAR Surgical is recalling the STAAR AQ Cartridge-FP because it may malfunction and may crack during loading or delivery of the IOL. Customers with questions are instructed to contact their STAAR customer service representative at (800) 352-7842.

Device

Device Recall STAAR AQ CartridgeFP
  • Model / Serial
    1281706, 1282812
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US
  • Product Description
    STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
  • Manufacturer
    Staar Surgical Co.

Manufacturer

Staar Surgical Co.
  • Manufacturer Address
    Staar Surgical Co., 1911 Walker Ave, Monrovia CA 91016-4846
  • Manufacturer Parent Company (2017)
    Staar Surgical Co.
  • Source
    USFDA