The Medicines and Healthcare products Regulatory Agency has issued a medical device alert in the United Kingdom for five Hoya one-piece foldable posterior-chamber IOL models due to higher than expected rates of inflammation and endophthalmitis observed after implantation, according to a news release.
Trace residual foreign particles were discovered on the NY-60, iSert 250, iSert 251, iSert Toric 351 and iSert Toric 311 model numbers, the release said. Hoya issued a voluntary recall of the devices in February while the company is investigating whether the foreign particles may be linked to adverse events.
Most adverse advents were reported within 90 days of implantation, and signs included cells and flare in the anterior chamber, potentially with hypopyon and corneal edema, the release said. Two cases demonstrated signs of acute bacterial endophthalmitis.
For specific serial numbers of the recalled devices, click here.