Events

Recall of Device Recall iSert Intraocular Lens (Model PC60AD)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hoya Surgical 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
    59207
  • Event Risk Class
    Class 2
  • Event Number
    Z-2802-2011
  • Event Initiated Date
    2011-06-17
  • Event Date Posted
    2011-07-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101699
  • 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
    The recall was initiated because hoya surgical optics has confirmed that the isymm intraocular lens (model fc-60ad) and isert intraocular lens (model pc-60ad) have been sold and marketed with out an fda approval.
  • Action
    Hoya Surgical Optics Inc. sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated June 22, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken. The letter instructs customers to quarantine affected product and return to HSO at their earliest convenience. Shipping instructions are included in the letter. Customers are to complete an Effectiveness Check Questionnaire and fax it to 1-909-680-3986. Questions regarding the recall process are directed to Hoya Customer Service at 1-866-750-5870 or e-mail at customercare@hoyasurgopt.com.

Device

Device Recall iSert Intraocular Lens (Model PC60AD)
  • Model / Serial
    This recall pertains to all serial numbers of I-ISO Model FC-60AD & PC-60AD lenses shipped to the U.S. and affected by this recall. A list of all affected serial numbers will be provided to the FDA LA District office. The total number of products on recall are 7355 different serial numbers on a excel spread sheet that will be attached when the Recall recommendation is sent to CDRH.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    iSert Intraocular Lens (Model PC-60AD)
  • Manufacturer
    Hoya Surgical Optics, Inc.

Manufacturer

Hoya Surgical Optics, Inc.
  • Manufacturer Address
    Hoya Surgical Optics, Inc., 14768 Pipeline Ave, Chino Hills CA 91709-3594
  • Manufacturer Parent Company (2017)
    Hoya Surgical Optics Inc.
  • Source
    USFDA