Events

Recall of Device Recall TECNIS

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
    75051
  • Event Risk Class
    Class 2
  • Event Number
    Z-2862-2016
  • Event Initiated Date
    2016-08-26
  • Event Date Posted
    2016-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149204
  • 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
    intraocular lens - Product Code HQL
  • Reason
    Abbott medical optics is recalling intraocular lenses (iols) because they were not being checked prior to release and this may result in the release of mislabeled iols.
  • Action
    Abbott Medical Optics, Inc. sent an Urgent Field Safety Notice to all affected customers to inform them that Abbott Medical Optics (AMO) is recalling 737 IOLs due to detection of an inspection equipment malfunction that resulted in a total of 737 distributed lenses not being fully checked prior to release. The letter informs customers that this malfunction may result in the release of mislabeled IOLs. The letter informs the customers of the actions to be taken. Customers are instructed to complete Customer Reply Form and fax it to AMO Quality Assurance at 714-247-4510 or email to RegCompliOne@abbott.com. Customers with any questions related to the IOL return process are instructed to contact an AMO Customer Service Representative at 877-266-4543. Customers with product complaints or adverse events are instructed to inform AMO by calling 877-266-4543.

Device

Device Recall TECNIS
  • Model / Serial
    Serial No. 5860621403 5860631403 5860641403 5860651403 5860661403 5860671403 5860681403 5860691403 5860701403 5860711403 5860721403 5860731403 5860741403 5860751403 5860771403 5860781403 5860791403 5860801403 5860811403 5860821403 5860831403 5860851403 5860871403 5860881403 5860891403 5860901403 5860911403 5860921403 5860931403 5860941403 5860951403 5860961403 5860971403 5860981403 5860991403 5861001403 5861011403 5861021403 5861031403 5861041403 5861051403 5861061403 5861081403 5861091403 5861101403 5861111403 5861391403 5861401403 5861411403 5861421403 5861431403 5861441403 5861451403 5861461403 5861471403 5861481403 5861491403 5861501403 5861511403 5861521403 5861531403 5861541403 5861551403 5861561403 5861581403 5861591403 5861601403 5861611403 5861621403 5861631403
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
  • Product Description
    TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery || System, Model No. PCB00V || The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag
  • 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