Indian-made drugs have been recalled from the drug market
After evaluation of incidents reported to the Medical Devices Surveillance System, the use of these drugs manufactured by APPASAMY OCULAR DEVICES (P) LTD, India is ordered to be discontinued and withdrawn from the market.
The decision was taken after reviewing incident reports submitted by two medical institutions – the IHR Municipal Clinical Hospital “Sfante Treime” and the IHR Republican Clinical Hospital “Timofei Mosneaga”, where the drug was used during ophthalmologic surgeries.
According to user reports, severe postoperative inflammatory reactions, including ocular inflammatory reactions, corneal edema and other complications were observed in patients who underwent surgical interventions using these drugs. In some cases, the complications progressed to severe visual impairment.
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