Hoya Intraocular Lenses

Device recall

3 April 2013

Health professionals and consumers are advised that Hoya Surgical Optics, in consultation with the TGA, is recalling certain Hoya One-Piece Intraocular Lenses (IOLs) that are in the supply chain. Hoya One-Piece IOLs are implanted in the eye to replace affected lenses during cataract surgery.

Model Description
NY-60 Hoya AF-1 iMICS1
311 Hoya AF-1 Toric
251 Hoya iSert
351 Hoya iSert Toric

In January 2013, Hoya Surgical Optics announced a voluntary suspension of shipment of five of their IOL products, while it investigated higher than expected rates of inflammation and/or endophthalmitis in Japan.

As a result of the findings of those investigations, a precautionary recall has been initiated, including in Australia.

The table identifies the affected models (all serial numbers manufactured between October 2011 and January 2013). Note that only the four models were supplied in Australia and the fifth model was not supplied in Australia.

Information for consumers

You are advised to contact your ophthalmologist if you have had a lens implanted in your eye and are experiencing symptoms of inflammation of the eye, including:

  • pain
  • itching
  • redness
  • change in vision, such as blurring
  • watering eyes/excessive tears
  • pain associated with bright lights.

Please note that no new cases of inflammation of the eye associated with Hoya IOLs that have been implanted for 6 months or longer have been reported.

If you have any general questions or concerns about IOLs, contact your ophthalmologist.

Information for all health professionals

Patients with any symptoms that suggest inflammation related to an IOL should be referred to an ophthalmologist, preferably the implanting ophthalmologist.

Information for ophthalmologists

Ophthalmologists are advised to stop usage of the identified models of Hoya One-Piece IOLs and to quarantine any of those products they have in stock.

Hoya Surgical Optics has written to every hospital that has been provided with Hoya IOLs, providing further information and advice regarding this recall.

For any patients who have already been implanted with one of the identified models, the following is recommended:

  • follow-up with the patient 3 months and 6 months after the operation to monitor for possible onset of ocular inflammation
  • review patients earlier, or as needed, if they are symptomatic.

No reports of any new cases of inflammation and/or endophthalmitis associated with Hoya IOLs that have been implanted for 6 months or longer have been reported.

The estimated number of affected IOLs implanted in Australia in the past six months is about 6000.

Additional information

From May to October 2012, the rate of reported inflammation and/or endophthalmitis in Japan for the Hoya iSert 251 was 0.08%. For the same period, the rate reported outside of Japan was less than 0.005%. A rate of 0.1% is considered acceptable under International Standard ISO 11979.

Subsequently, Hoya Surgical Optics conducted an extensive review of its manufacturing process and found that some products had trace metallic particulates on them.

It was determined that the source of the particulates was linked to certain components in equipment used during the manufacturing process for all of the affected models.

Hoya Surgical Optics was unable to definitely determine if the particulates were linked to the higher than expected rates of inflammation and/or endophthalmitis, but found that the potential for such a link existed.

Based on those findings, the company initiated a precautionary recall of the identified models and is implementing manufacturing improvements to prevent similar problems in the future. It will not resume manufacturing of the affected models until these improvements are made.

No other Hoya IOLs (in particular Three-Piece IOLs) are affected by this recall.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.