Events

Recall of Device Recall Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112

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
    59662
  • Event Risk Class
    Class 2
  • Event Number
    Z-3089-2011
  • Event Initiated Date
    2011-07-27
  • Event Date Posted
    2011-08-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103243
  • 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
    Phacofragmentationn Unit - Product Code HQC
  • Reason
    The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction.
  • Action
    Bausch & Lomb Inc. notified all affected customers by direct telephone contact on July 27, 2011 and a follow-up FAX or e-mail dated July 27, 2011 The letter included; affected product, problem, and requests customers return the product. An acknowledgement form was included to complete and return with the product. For question on this recall contact Bausch & Lomb at (949) 521-7895.

Device

Device Recall Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112
  • Model / Serial
    Model # BL5112, Lot #U6476,  Exp. 11/2012
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112, packaged 6 units/case, RX, Sterile. || Bausch & Lomb Incorporated, || Rochester, NY || For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery
  • Manufacturer
    Bausch & Lomb Inc

Manufacturer

Bausch & Lomb Inc
  • Manufacturer Address
    Bausch & Lomb Inc, 1400 North Goodman Street, Rochester NY 14609-3547
  • Source
    USFDA