CDSCO Issues Medical Device Alert For HOYA Vivinex iSert Toric IOLs
New Delhi: Following the recall action notification for Hoya Vivinex isert Toric Intraocular Lens (IOLs) from the Department of Health, Therapeutics Goods Administration, Australian Government, the Central Drugs Standard Control Organization (CDSCO) has issued a Medical Device Alert for HOYA Vivinex Toric IOLs (Model Numbers: XY1AT2, XY1AT3, XY1AT4, XY1AT5, XY1AT6, XY1AT7, XY1AT8, and XY1AT9) manufactured by HOYA Surgical Optics, from June 2022 to January 2023.
The Medical Device Alert stated that HOYA Surgical Optics is recalling HOYA Vivinex iSert Toric IOLs from a specified manufacturing period (June 2022 to January 2023).
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 Intraocular Lens (IOL) surface, it has been demonstrated to provide a low incidence of Posterior Capsule Opacification (PCO) in several studies.
The Medical Device Alert specified, "HOYA Surgical Optics is recalling HOYA Vivinex iSert Toric IOLs from a specified manufacturing period (June 2022 to January 2023). Recall Action Classification Class II, Recall Action Commencement Date 12.04.2023."
The alert's explanation of the reason for the recall stated that it was being carried out in response to customer complaints concerning damage (such as scratches) and fragment adhesion on the IOL optic surface produced in Australia and Japan.
Furthermore, explaining the damage (such as scratches) and fragment adhesion on the IOL optic surface, the medical device alert highlighted, "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 alert added.
In the Recall Action Notification issued by the Department of Health, Therapeutics Goods Administration, Australian Government, HOYA Surgical Optics ask customers to place all impacted devices on hold in their inventory system and quarantine them for collection by a Designs For Vision representative.
Additionally, HOYA Surgical Optics noted, "IOL explantation is not recommended, however, it is recommended that the patients involved, i.e., the cases where lenses with PP adhesion have been left in the eye, be monitored for the need for any future medical treatment."
