Events

Recall of Microflow Needles, catalog #DP8200, with 0 degree tapering, labeled in part ***Non-sterile, Manufactured for Bausch and Lomb, Inc. Rochester, NY 14609***, packaged 6 needles/box.

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

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
    27058
  • Event Risk Class
    Class 2
  • Event Number
    Z-1279-03
  • Event Initiated Date
    2003-08-25
  • Event Date Posted
    2003-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29098
  • 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
    Unit, Phacofragmentation - Product Code HQC
  • Reason
    The firm's dp8200 microflow needle packs were labeled with the firm's dp8115 phaco needle packs and visa versa.
  • Action
    Firm notified customers by phone and letter 8/25/2003 and advised of needle mix-up. Customers were requested to quarantine affected product and return product with response form.

Device

Microflow Needles, catalog #DP8200, with 0 degree tapering, labeled in part ***Non-sterile, Manuf...
  • Model / Serial
    Julian date coded ''2003163''
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was sold to 6 direct accounts in FL, IA, WI, MA and IL. Product was additionally sold to 4 international distributors.
  • Product Description
    Microflow Needles, catalog #DP8200, with 0 degree tapering, labeled in part ***Non-sterile, Manufactured for Bausch and Lomb, Inc. Rochester, NY 14609***, packaged 6 needles/box.
  • Manufacturer
    Bausch & Lomb Incorporated

Manufacturer

Bausch & Lomb Incorporated
  • Manufacturer Address
    Bausch & Lomb Incorporated, 1501 Graves Mill Road, Lynchburg VA 24502
  • Source
    USFDA