Events

Recall of Device Recall AMO Vitrectomy Cutter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Medical Optics Inc. (AMO).

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
    77024
  • Event Risk Class
    Class 2
  • Event Number
    Z-2096-2017
  • Event Initiated Date
    2017-03-30
  • Event Date Posted
    2017-05-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154841
  • 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
    Vitrectomy, instrument cutter - Product Code MLZ
  • Reason
    Packaging error. 20ga vitrectomy cutters may be found in a 25ga package and 25ga vitrectomy cutters may be found in a 20ga package.
  • Action
    An Urgent Field Safety notice was sent on 3/30/17 to inform customers that AMO has voluntarily initiated this Action because a possibility exists that, due to a packaging error, 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package. Use of a Vitrectomy Cutter that is a different size than expected could lead to the need to alter the surgical technique, including conjunctival dissection, incision enlargement and scleral sutures.

Device

Device Recall AMO Vitrectomy Cutter
  • Model / Serial
    Part Number NGP0025 Lot CA06182 (72 units) Part Number NGP0020 Lot CA06180 (288 units)
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution to SA, TR, AZ, NL, PT, SG, AU, JP, and HK.
  • Product Description
    AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use.
  • Manufacturer
    Abbott Medical Optics Inc. (AMO)

Manufacturer

Abbott Medical Optics Inc. (AMO)
  • Manufacturer Address
    Abbott Medical Optics Inc. (AMO), 1700 E Saint Andrew Pl, Santa Ana CA 92705-4933
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA