One-Piece Intraocular Lenses 의 안전성 경고

Safety alert

2013-02-22

2013-02-22

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130222a.html

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.