Events

Recall of Device Recall OptiMedica Catalys Precision Laser System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Medical Optics, 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
    70679
  • Event Risk Class
    Class 2
  • Event Number
    Z-1515-2015
  • Event Initiated Date
    2015-02-20
  • Event Date Posted
    2015-04-23
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134478
  • 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
    Ophthalmic femtosecond laser - Product Code OOE
  • Reason
    Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
  • Action
    Abbott Medical Optics (AMO) sent an Advisory Notice letter dated March 5, 2015 via FedEx overnight delivery to each Catalys Precision Laser System owner. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the attached Acknowledgement Form. For questions contact AMO Technical Support at 1-855-662-0911.

Device

Device Recall OptiMedica Catalys Precision Laser System
  • Model / Serial
    Device Serial No. (U.S.) 44055311 44055611 44055811 44056012 44056312 44056612 44056712 44056812 44057312 44057812 44058012 44058212 44058312 44059212 44059312 44059612 44059712 44059812 44059912 44060012 44060112 44060312 44060412 44060612 44060712 44060912 44061012 44061412 44061612 44061812 44062013 44062213 44062413 44062613 44062813 44063113 44063313 44063413 44063513 44063613 44063713 44063813 44063913 44064113 44064313 44064413 44064513 44064613 44064713 44064813 44065013 44065113 44065213 44065313 44065413 44065613 44066213 44066413 44066613 44066914 44067014 44068014 44068314 44068914 44069114 44069414 44069814 44070414 44070914 44071914 44072114 44072414 44072714 44072814 44072914 44073014 44073114 44073214 44073314 44073514 44073714 44074114 44074514 44074614 44074814 44100714 44100814 44101014 44101114 44101414 44101614 44102514 44102614 44102714  Device Serial No. (Outside U.S.) 44055211 44055411 44055711 44055911 44056112 44056212 44056412 44056512 44056912 44057112 44057212 44057412 44057512 44057612 44057712 44057912 44058112 44058512 44058612 44058912 44059012 44059112 44059412 44059512 44060212 44060512 44061112 44061212 44061312 44061512 44061712 44061913 44062113 44062313 44062913 44063013 44063213 44064013 44064213 44065513 44065713 44065813 44065913 44066313 44066513 44066713 44066813 44067114 44067214 44067414 44067514 44067614 44067714 44067914 44068114 44068214 44068414 44068514 44068614 44069014 44069214 44069314 44069514 44069914 44070014 44070114 44070214 44070314 44070514 44070614 44070714 44070814 44071014 44071114 44071214 44071314 44071414 44071514 44071614 44071714 44071814 44072014 44072214 44072314 44072514 44072614 44073414 44073614 44073814 44073914 44074014 44074214 44074314 44074414 44074714 44074914 44100114 44100214 44100614 44100914 44101314 44101514 44101714 44101814 44101914 44102014 44102114 44064913R
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of, Canada, Germany, Switzerland, Australia, Spain, Japan, Great Britain, France, Netherlands, Austria, Singapore, South Korea, India, Thailand, Colombia, Ecuador, Italy, Brazil, Egypt, Tunsia, Belgium, Mexico, Greece, Guatemala, Chile, Turkey, Peru, Hong Kong, Saudi Arabia, Bangladesh, and Dominican Rep.
  • Product Description
    OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). || Product Usage: || Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.
  • Manufacturer
    Abbott Medical Optics, Inc.

Manufacturer

Abbott Medical Optics, Inc.
  • Manufacturer Address
    Abbott Medical Optics, Inc., 510 Cottonwood Dr, Milpitas CA 95035-7403
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA