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) 의 리콜

Recall

RC-2013-RN-00164-1

Class I

2013-02-22

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00164-1

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.

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 .