Hoya Surgical Optics Recalls Intraocular Lenses Over Adverse Event Reports

Hoya Surgical Optics of Singapore just issued a recall for some of its intraocular lenses.

The recall was implemented following international reports of higher-than-expected incidences of inflammation and endophthalmitis, said Mass Device. The recall involves five models of Hoya Surgical Optics’ intraocular lenses. Medscape describes endophthalmitis as an inflammatory condition of the intraocular cavities—the aqueous and/or vitreous humor (the clear gel between the lens and the retina)—and is usually due to infection.

Healthcare regulators in both the United Kingdom and Australia have reported the recall and are urging physicians to immediately cease using the implants, said MassDevice. Hoya Surgical Optics, at first, stopped certain shipments of the intraocular implants while it investigated adverse event reports that were linked to three of its intraocular lenses.

In addition to the three lenses involved, Hoya Surgical Optics has since recalled two other lenses that follow a similar manufacturing process, said MassDevice.

“The patient data shared with us showed sterile, resolved reports without any permanent injury following appropriate treatment in all but very few cases,” said Hoya’s 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 letter also stated.

The adverse event incident rate being seen with the recalled Hoya Surgical Optics intraocular lenses is between 0.03 and 0.3 percent globally, U.K health care authorities have stated, said Mass Device.

Patients implanted with the recalled intraocular lenses may experience pain, redness, or loss of vision in the eye in which the lens was implanted, MassDevice wroe.

Intraocular lenses are artificial lenses that are typically implanted into the eye, unusually to replace a damaged natural lens or to treat myopia (nearsightedness). The lenses are also used following cataract removal surgery.

The intraocular lens devices generally replace the eye’s lens, usually when that lens becomes clouded due to cataracts. In some cases, these lenses are placed over the natural lens in refractive surgery to correct the eye’s optical power.

This entry was posted in Product Recalls, Recalled Medical Devices. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.