Events

Recall of Device Recall SENSAR

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-2855-2016
  • 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=149193
  • 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 SENSAR
  • Model / Serial
    Serial No. 5626941507 5626961507 5626981507 5627001507 2003061505 2004131506 2015871503 3848581509 5626621507 5626641507 5626651507 5626661507 5626671507 5626681507 5626691507 5626701507 5626711507 5626721507 5626731507 5626741507 5626751507 5626761507 5626771507 5626791507 5626801507 5626811507 5626821507 5626831507 5626841507 5626851507 5626861507 5626871507 5626881507 5626891507 5626901507 5626911507 5626921507 5626931507 5626951507 5626971507 5627011507 5627021507 5627031507 5627041507 5627051507 5627061507 5627071507 5627081507 5627091507 5627101507 5627111507 5627121507 5627131507 5627141507 5627151507 5627161507 5627171507 5627181507 5627191507 5627201507 5627211507 5627221507
  • 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
    SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e || 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