Taking cue from customer complaints in Australia and Japan with reports of damage (such as scratches) and fragment adhesion on the Hoya Surgical Optics manufactured Hoya Vivinex Toric IntraOcular Lens (IOLs) , such units from various batches in India are also being recalled. The top drug regulator DCGI here has issued an alert on a total of 3,822 units manufactured from June, 2022 to January, 2023.
Hoya, the global med-tech company in Tokyo and a leading supplier of innovative high-tech and medical products, informed the DCGI 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.
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.