Events

Recall of Device Recall LaserEdge Knives

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bausch & Lomb Inc Irb.

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
    76874
  • Event Risk Class
    Class 2
  • Event Number
    Z-0855-2018
  • Event Initiated Date
    2017-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159986
  • 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
    Knife, ophthalmic - Product Code HNN
  • Reason
    The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, bausch + lomb is voluntarily recalling all product codes sku manufacturing without the electro-polish control and penetration force testing.
  • Action
    On March 3, 2017 Bausch + Lomb , distributed Urgent Medical Device Recall notices and Acknowledgement Forms to customers via FedEx. Customers were advised to: 1. Please review your inventory and quarantine all unused (full and partial) boxes of LaserEdge" knives (6/Box or individual packaged knives) affected lots. 2. Complete the enclosed Medical Device Voluntary Recall Acknowledgement Form and contact Bausch + Lomb to obtain a Return Material Authorization Number (RMA) and arrange for a pickup of the identified product. You can contact the Bausch + Lomb Surgical Customer Service team by calling 1-800-338-2020, Customer Service (option 2), Product Returns and Adverse Event Reporting (option 2). Please contact the Bausch + Lomb Surgical Customer Service team with any questions or concerns regarding this process: 1-800-338-2020.

Device

Device Recall LaserEdge Knives
  • Model / Serial
    none
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    LASEREDGE Knives, 2.75MM THIN SLIT ANGLED BEVELED UP (6/BOX)(6/BOX), REF/PRODUCT CODE E7759A, STERILE, Rx Only || Product Usage: || The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
  • Manufacturer
    Bausch & Lomb Inc Irb

Manufacturer

Bausch & Lomb Inc Irb
  • Manufacturer Address
    Bausch & Lomb Inc Irb, 1400 Goodman St N, Rochester NY 14609-3547
  • Manufacturer Parent Company (2017)
    Bausch Health Cos., Inc.
  • Source
    USFDA