Last Updated on December 31, 2023 by The Health Master
Medical Device alert
The Central Drugs Standard Control Organisation (CDSCO) has recently issued a medical device alert regarding specific batches of Hoya Vivinex Toric Intra Ocular Lens (IOLs) that were manufactured between June 2022 and January 2023.
The company, Hoya Surgical Optics, has initiated a recall of these IOLs, classifying it as a Class II recall action starting from April 12, 2023.
The CDSCO has listed a total of 3,822 units from various batches in India based on the information provided by the company.
Reasons for the Recall
The medical device alert highlights the customer complaints received by Hoya Surgical Optics in Australia and Japan.
These complaints reported instances of damage, such as scratches, and fragment adhesion on the surface of the IOL optic.
Upon investigation of the returned samples, Hoya discovered that the damage occurred to the nozzle tip of the iSert injector during the implantation of Toric IOLs.
This damage potentially led to the reported scratches on the optic surface and the adherence of polypropylene (PP) resin fragments from inside the injector tip to the IOL surface (PP adhesion).
Recall Actions and Recommendations
Hoya Surgical Optics has submitted a recall action notification for the affected lenses to the Department of Health, Therapeutics Goods Administration (TGA) of the Australian government.
They have also issued an alert recalling the product in India. The company’s Indian arm, Hoya Medical India Pvt Ltd, based in New Delhi, is responsible for these actions.
As part of the recall, Hoya has requested its customers to place all impacted devices on hold in their inventory system and quarantine them for collection by the company’s designated entity in the country.
Additionally, the company recommends closely monitoring patients who have received lenses with PP adhesion in their eyes for any potential future medical treatment requirements.
About Hoya and its Commitment
Hoya, a globally recognized med-tech company founded in Tokyo, Japan in 1941, is a leading supplier of innovative high-tech and medical products.
With a presence in the fields of healthcare and information technology, Hoya provides various products such as eyeglasses, medical endoscopes, intra ocular lenses, optical lenses, and key components for semiconductor devices and LCD panels.
The company operates through more than 150 offices and subsidiaries worldwide, employing over 36,000 people from diverse backgrounds, as stated on its official website.
Hoya Surgical Optics, a division of Hoya, is dedicated to delivering top-quality preloaded IOLs along with personalized services and specialized support to healthcare professionals.
Conclusion:
The CDSCO has issued a medical device alert for Hoya Vivinex Toric Intra Ocular Lens (IOLs) due to customer complaints regarding damage and fragment adhesion.
Hoya Surgical Optics has initiated a recall of these IOLs, and affected customers have been advised to quarantine the devices.
Monitoring of patients who have received lenses with PP adhesion is recommended.
Hoya, a prominent med-tech company, is committed to providing cutting-edge medical products and services to meet the needs of healthcare professionals.
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