Events

Recall of HOYA One-Piece Intraocular Lenses (IOL) Models : HOYA AF-1 iMICS1 (NY-60), HOYA AF-1 Toric (311), HOYA iSert (250 and 251), HOYA iSert Toric (351)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Designs for Vision Aust Pty Ltd.

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
    RC-2013-RN-00164-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-02-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00164-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    This recall/hazard alert is being undertaken following higher than expected reported rates of inflammation and/or endophthalmitis from doctors using ny-60, isert 250, and isert 251 iols in a few countries. an extensive review of the manufacturing process by hoya revealed that some products had trace residual foreign particulates on them.
  • Action
    Please quarantine and return all the affected stock to Designs For vision Pty Ltd. For any patient already implanted with one of the lenses included in this recall. For any patient already implanted with one of the lenses included in this recall, Hoya is recommending follow-up with the patient at three (3) and six (6) months post-operatively to monitor for the possible onset of ocular inflammation. Patients should be reviewed earlier, or as needed, if symptomatic. For more details, please see http://www.tga.gov.au/safety/alerts-device-hoya-intraocular-lenses-130403.htm#consumers .

Device

HOYA One-Piece Intraocular Lenses (IOL) Models : HOYA AF-1 iMICS1 (NY-60), HOYA AF-1 Toric (311),...
  • Model / Serial
    HOYA One-Piece Intraocular Lenses (IOL) Models : HOYA AF-1 iMICS1 (NY-60), HOYA AF-1 Toric (311), HOYA iSert (250 and 251), HOYA iSert Toric (351)Affected Serial numbers ranges:KULX0011 - KUMZ0TN2)JKLX0012 - JKN10CE4JLLX0012 - JLN116T6PNLX0012 - PNMZ04Q8PPLX0011 - PPMZ01C8PQLX0021 - PQMZ00E7PRLX0011 - PRMZ00R6PSLX0012 - PSMZ0078PTLX0011 - PTMZ0048PULX0011 - PUMZ00E8PALY0011 - PAM200S6PBLY0011 - PBM200C8PCLY0011 - PCM200N8ARTG: 117417
  • Manufacturer
    Designs for Vision Aust Pty Ltd

Manufacturer

Designs for Vision Aust Pty Ltd