Singapore-based Hoya Surgical Optics recalled 5 models of its intraocular lenses after receiving reports of higher-than expected rates of inflammation from doctors in several countries.
Healthcare regulators in the U.K. and in Australia have both reported the recall, asking doctors to stop using the implants immediately.
The company initially suspended certain shipments of the intraocular implants while it investigated adverse event reports tied to 3 of its lenses: the NY‐60, iSert 250 and iSert 251 IOLS.
"The patient data shared with us showed sterile,resolved reports without any permanent injury following appropriate treatment in all but very few cases," according to a Hoya warning letter. "An extensive review of our manufacturing process revealed that some products had trace residual foreign particulates on them. We have been unable to definitely determine if they were linked to the adverse events but the potential may exist."
The adverse event incident rate is between 0.03%-0.3% worldwide, according to U.K. healthcare authorities. Patients may experience pain or redness or loss of vision in the eye.
As a precautionary measure the company initiated a voluntary recall of the 3 lenses in question as well as 2 others that follow a similar manufacturing process: Toric 311, and iSert Toric 351.
Hoya is implementing changes to its manufacturing process to mitigate future problems, and plans to resume manufacturing of all 5 lenses once it gets the go-ahead from regulators.