SINGAPORE, January 31, 2013 — HOYA Surgical Optics announced that it has received higher than expected reported rates of inflammation and/or endophthalmitis from doctors using iSert® 250, iSert® 251, and NY-60 IOLs in a few countries.
Despite an extensive investigation the exact cause of these adverse events has not been defined. All data collected to date, including evaluations of biocompatibility, bioburden, and cytotoxicity, indicate that HOYA IOLs meet or exceed all industry standard specifications.
HOYA Surgical Optics is committed to providing only the highest quality IOLs possible and protecting patient health. Therefore, as a precautionary measure, HOYA has voluntarily suspended shipment of these, and other similarly produced products, until further analysis is conducted.
HOYA apologizes for any inconvenience this may create.