Events

Recall of Device Recall Horizon

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by American Optisurgical 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
    52697
  • Event Risk Class
    Class 2
  • Event Number
    Z-1808-2009
  • Event Initiated Date
    2009-03-24
  • Event Date Posted
    2009-09-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83671
  • 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
    phacoemulsification system - Product Code HQC
  • Reason
    Device operation interrupted: a software bug causes phaco to stop when vacuum goes above 300 mmhg while in multi burst mode. use of this product at the parameters specified above could lead to a delay in surgery that might present a health risk.
  • Action
    American Optisurgery sent an E-mail to customers on April 2, 2009 stating the reason for recall and informed them to immediately examine their inventory and quarantine product subject to recall. In addition, if they have further distributed this product, please identify customers and identify them at once of this product recall. Their notification to customers may be enhanced by including a copy of this recall notification letter. They were then told to refer to the enclosed Recall Questionnaire for instructions on what to do with the recalled product: The recall should be carried out to the user level and return the enclosed response form as soon as possible. If there are any questions, they are advised to contact David Salzberg at (800) 576-1266.

Device

Device Recall Horizon
  • Model / Serial
    Serial Numbers: 1114, 1116, 1118, 1120-1124, and 1126-1129.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (California), Brazil, Algeria, France, South Korea, India, and Peru.
  • Product Description
    American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery.
  • Manufacturer
    American Optisurgical Inc

Manufacturer

American Optisurgical Inc
  • Manufacturer Address
    American Optisurgical Inc, 25501 Arctic Ocean Dr, Lake Forest CA 92630
  • Manufacturer Parent Company (2017)
    American Optisurgical Inc
  • Source
    USFDA