Events

Recall of Zyoptix XP Microkeratome tray

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
    47839
  • Event Risk Class
    Class 2
  • Event Number
    Z-0104-2009
  • Event Initiated Date
    2008-04-23
  • Event Date Posted
    2008-10-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72813
  • 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
    Ac-Powered Keratome - Product Code HNO
  • Reason
    The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.
  • Action
    Phone calls were initiated on 4/28/08 and an Urgent Recall letter dated 4/23/08 was issued 4/28/08 via overnight mail to U.S. customers explaining the reason for recall. The letter also requested that customers stop using the motors identified and return of the motors for evaluation. A return form was enclosed.

Device

Zyoptix XP Microkeratome tray
  • Model / Serial
    Tray/motor serial numbers: 11061/77318906, 10980/77318909, 11019/77318920, 11029/77318925, 11084/77318926, 10969/77504001, 11046/77504002, 11000/77504005, 11088/77504006, 11045/77504007, 11068/77504008, 11108/77504009, 10972/77504011, 11106/77504014, 11021/77504015, 11177/77732302, 11202/77732307, 11091/77732316, 11031/77732318, 11066/77898701, 11026/77898702, 11077/77898704, 11120/77898705, 11103/77898706, 11040/77898707, 11192/77898708, 11190/77898712, 11174/77898713, 11153/77898714, 11030/77898715, 11111/78080317, 11047/78080319, 11150/78080321, 10904/78080323, 11149/78080324, 11096/78080325, 11041/78080333, 11081/78080334, 11064/78080335, 11221/78080339, 11122/78080340, 11034/78080341, 11140/78080342, 11089/78207127
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Brazil, The Netherlands, Canada, India, Malaysia, Mexico, and Singapore.
  • Product Description
    Zyoptix XP Microkeratome tray, Ref. #ZXP1000, which contains a number of components, one of which is the maxon motor. The label shows the product is manufactured by Bausch & Lomb Incorporated, Rochester, NY.
  • Manufacturer
    Bausch & Lomb Inc

Manufacturer

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