Japanese conglomerate Hoya is facing problems in the U.K. over high rates of inflammation and infection stemming from its intraocular lens implants.
The company voluntarily recalled 5 of the products in February after determining that some of them were contaminated with small amounts of foreign particles. And now the Medicines and Healthcare products Regulatory Agency issued a formal medical device alert in the U.K. for each of the five models, Healio reports.
There's a lot of caution at play here. So far, no reports have surfaced yet in the U.K. about any inflammation or infection problems with the affected implants. And Hoya told regulators that they haven't had any new "adverse event" reports regarding affected implants in use for 6 months or longer.
The NY-60, iSert 250, iSert 251, iSert, Toric 351 and iSert and Toric 311 models are all affected by the action. Meanwhile, Hoya is looking into whether the particles caused the higher inflammation/infection rates or if another factor contributed to the problems. Hoya had no reports of problems with the Toric models but they are included in the warning anyway, as a precaution, because of a similar manufacturing process.
U.K. regulators said Hoya's other intraocular lens implants are unaffected by the recall and investigation. Regulators, meanwhile, are urging providers to return the affected models and are seeking recommendations from Hoya about how to handle patients who already have one of the recalled lens implants.
Hoya's medical products cover a wide range. In addition to intraocular lens implants, the company's medical division also produces medical endoscopes, bone prostheses, speech instruments, airway scopes and many other devices, according to its website.