Events

Recall of AlgerbrushII

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bausch & Lomb, 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
    75915
  • Event Risk Class
    Class 2
  • Event Number
    Z-0983-2017
  • Event Initiated Date
    2016-10-12
  • Event Date Posted
    2017-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151706
  • 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
    Burr, corneal, battery powered, rust ring removal - Product Code OHW
  • Reason
    According to firm ( bausch & lomb, inc. ) on june 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of sku 0816 c (pterygium burr medium diamond). further investigation found that repackaged algerbrush-ii and its accessories from april 30, 2012 to present, contained out of date operating instruction. therefore bausch & lomb is proposing a field correction to provide customer purchasing product from april 30, 2012 to june 20, 2016 with the current operating instruction.
  • Action
    Bausch + Lomb sent an Urgent Medical Device Voluntary Field Correction letter dated October 12, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact Bausch + Lomb customer service at 1-800-338-2020

Device

AlgerbrushII
  • Model / Serial
    LOT #(s) AND EXPIRATION DATES, SERIAL #(s), ORDER #, or OTHER IDENTIFICATION #(s):  SKU E0815 A, SKU E0815 B, SKU E0815 0.5, SKU E0815 1.0 and SKU E0816 C
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    Algerbrush-II || Product Usage: || Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient
  • Manufacturer
    Bausch & Lomb, Inc.

Manufacturer

Bausch & Lomb, Inc.
  • Manufacturer Address
    Bausch & Lomb, Inc., 1501 Graves Mill Rd, Lynchburg VA 24502-4328
  • Manufacturer Parent Company (2017)
    Bausch Health Cos., Inc.
  • Source
    USFDA