National Coordination Centre – Materiovigilance Programme of India (MvPI), Indian Pharmacopoeia Commission asks members of AIOS to come forward with reports of adverse events
National Coordination Centre – Materiovigilance Programme of India (MvPI), Indian Pharmacopoeia Commission (NCC-MvPI, IPC) has urged members of All India Ophthalmological Society (AIOS) to send samples of Intraocular Lens (IOLs) from certain batches for a fair evaluation. There are reports from multiple centres that the lenses by Care Group and Staar Surgical are leading to serious adverse events. Reports have surfaced that the products are causing Toxic Anterior Segment Syndrome (TASS) in patients.
Post-operative inflammation has been reported after cataract surgery by members of the All India Ophthalmological Society (AIOS). It has been decided that an enquiry will be organised by the AIOS secretariat. Members of AIOS are hereby being requested to send the sample of IOLs from the concerned batches for a fair evaluation. The IOLs will be tested for endotoxins and monomers from reputed laboratories.
National Coordination Centre – Materiovigilance programme of India, Indian Pharmacopoeia Commission (NCC-MvPI, IPC) periodically communicates safety alert information to all Adverse Drug Reaction Monitoring Centers (AMCs) under Pharmacovigilance Programme of India (PvPI) and Medical Device Adverse Event Monitoring Centers (MDMCs) under Materiovigilance Programme of India (MvPI) for the active surveillance and reference only.
