Events

Recall of Device Recall CX9625 Light Pipe (25 Gauge).

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
    27714
  • Event Risk Class
    Class 2
  • Event Number
    Z-0264-04
  • Event Initiated Date
    2003-11-10
  • Event Date Posted
    2003-12-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30396
  • 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
    Transilluminator, Ac-Powered - Product Code HJM
  • Reason
    The cx9625 light pipe connector may overheat; this condition could result in the plastic connector that plugs into the millennium microsurgical system to malfunction.
  • Action
    The recalling firm issued a recall notification dated 11/13/03 to their direct accounts. The recall notification explains the problem and return the product.

Device

Device Recall CX9625 Light Pipe (25 Gauge).
  • Model / Serial
    Lot numbers: 207089, 209102, 02121321, 02171838, 02192048, 02212272, 02222332, 02242552, 02262741, 02272856, 02293066, 02313269, 02323381, 02333458, 02363752, 02383927, 02404141, 02414225, 02424507, 02434421, 02434520, 02444529, 02454627, 02454672, 02464725, 02474823, 02484921, 02505121, 03020326, 03040522, 03040669, 03060728, 03060803, 03060865, 03080924, 03101124, 03111222, 03131428, 03151624, 03171820, 03171998, 03192023, 03212226, 03212370, 03232422, 03242537, 03252628, 03262726, 03303276, and 03303313.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to hospitals/medical facilities and physicians in AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NJ, NH, NY, NC, OH, PA, TN, TX, UT, VA, WA, WI, and WV. Nationwide. The product was also shipped to Puerto Rico, Argentina, Australia, Brazil, Canada, China, Hong, Kong, India, Japan, Korea, Malaysia, Mexico, New Zealand, The Netherlands, Philippines, Singapore, Spain, Taiwan, and Thailand.
  • Product Description
    CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes.
  • Manufacturer
    Bausch & Lomb Inc

Manufacturer

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