Events

Safety Alert for One-Piece Intraocular Lenses

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Hoya Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-02-22
  • Event Date Posted
    2013-02-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130222a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: hoya one-piece intraocular lenses medical device manufacturer, hoya corporation issued a medical device safety alert concerning hoya one-piece intraocular lenses (iol). the affected models are: ny-60 (hoya af-1 imics1) 311 (hoya af-1 toric) 250 and 251 (hoya isert) 351 (hoya isert toric) last month, hoya surgical optics announced a voluntary suspension of shipment of five of their products while they investigated reports of higher than expected 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 manufacturing process revealed that some products had trace residual foreign particulates on them. the manufacturer has been unable to definitively determine if they were linked to the adverse events but the potential may exist. although no adverse events have been reported with the toric lenses, they were included in the recall because they follow a similar manufacturing process. the manufacturer clarified that no other hoya iols, in particular no three-piece iols, are affected by this recall. according to the manufacturer, this issue may lead to post-operative inflammation and/or endophthalmitis. however, there is no evidence, and no reports of any new cases of inflammation and or endophthalmitis associated with the iols that have been implanted for six months or longer. product recall is ongoing. furthermore, for any patient already implanted with one of the lenses included in this recall, hoya recommends following the patient for three to six months post-operatively to monitor for the possible onset of ocular inflammation. according to the local supplier, hong kong medical supplies ltd., the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 february 2013.

Device

One-Piece Intraocular Lenses
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: HOYA One-Piece Intraocular Lenses
  • Manufacturer
    Hoya Corporation

Manufacturer

Hoya Corporation