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CDSCO issues medical device alert on Hoya Vivinex Toric IOLs manufactured from June 2022 to Jan 2023

Gireesh Babu, New Delhi
Friday, May 26, 2023, 08:00 Hrs  [IST]

The Central Drugs Standard Control Organisation (CDSCO) has issued a medical device alert on certain batches of Hoya Vivinex Toric IntraOcular Lens (IOLs) manufactured from June, 2022 to January, 2023. The drug regulator has also listed a total of 3,822 units from various batches in India, based on a filing by the company.

According to the medical device alert, Hoya Surgical Optics has started recalling these IOLs under recall action classification Class II, commencing from April 12, 2023.

The company informed that the recall is being made following customer complaints received in Australia and Japan with reports of damage (such as scratches) and fragment adhesion on the IOL optic surface.

“Following the initial investigation of returned samples, Hoya identified that damage had occurred to the nozzle tip of the iSert injector during Toric IOL implantation. This damage might have led to the reported scratches on the optic surface and polypropylene (PP) resin fragments from inside the injector tip to adhere to the IOL surface (PP adhesion)”

The company also submitted the recall action notification for the lenses from the Department of Health, Therapeutics Goods Administration (TGA), Australian government, along with the alert recalling the product in India. The company has its Indian arm as Hoya Medical India Pvt Ltd, in New Delhi.

In its filing with the TGA, the company said that it has asked customers to place all impacted devices on hold in their inventory system and quarantine them for collection by its responsible entity in the country. It also recommended that the patients involved, that is the cases where lenses with PP adhesion have been left in the eye, be monitored for the need for any future medical treatment.

Hoya says that Vivinex is made from a novel hydrophobic acrylic, using a proprietary manufacturing process that includes a unique, active oxygen posterior surface treatment. Combined with its square edge design and smooth, regular IOL surface, it has been demonstrated to provide a low incidence of Posterior Capsule Opacification (PCO) in several studies.

Hoya is a global med-tech company founded in 1941 in Tokyo, Japan and it is a leading supplier of innovative high-tech and medical products. The company is active in the fields of healthcare and information technology providing eyeglasses, medical endoscopes, intraocular lenses, optical lenses as well as key components for semiconductor devices, LCD panels and others. It has over 150 offices and subsidiaries worldwide, and currently employs a multinational workforce of over 36,000 people, says the company website.

Hoya Surgical Optics says that it is devoted to delivering the world’s leading preloaded IOLs, personalised services and specialised support.


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