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About Defects In Intraocular Lens ( IOL )


Intraocular lens may have defect during the manufacturing process and implantation into the patients' eyes. This ranges from the production of IOL, packaging, distribution, insertion to when the IOL is already implanted into the patients' eyes.


Defect may range from manufacturing defect such as no IOL in the box or fracture of haptics or optics. It may also be in the form of deposits on the IOL or opacification detected weeks to years after surgery. All these defects will contribute directly to the patients' visual outcome. Some defects may require explantation and results in distress to both the patients and surgeons. Cost for explantation of an opacified IOL also has to be borne by the patient and eye care providers.


It is also important to identify any common defect for example fracture of haptics or optics as this will be used as feedback to the industries to improve their IOL quality or be used for platform for further training pertaining to the IOL if required.


CDSCO Medical Device alert on IOLs


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 Company has started recalling these IOLs under recall action classification Class II, because of reports of damage (such as scratches) and fragment adhesion on the IOL optic surface.


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) 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 has its Indian arm as Hoya Medical India Pvt Ltd, in New Delhi. The Company has 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.


As per Hoya, lenses are 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.


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