Ministry of Health cautions public on use of medical device
Raindrop Near Vision Inlay is surgically implanted in the eyes to improve eyesight
Abu Dhabi: The Ministry of Health and Prevention (MoHAP) has released a circular cautioning the public on the use of a medical device used to improve eyesight and one batch of a medicine used for the treatment of hypertension.
Both products are not registered in the Ministry of Health and Prevention, but it was decided to release the relevant circulars as a precautionary measure to protect public health.
Dr Ruqaya Al Bastaki, Head of the Drug Department at MoHAP, said: “The Ministry has issued a circular following a warning sent out by the US Food and Drug Administration [FDA] against the use of Raindrop Near Vision Inlay, a medical device produced by Optics Medical Company. More commonly known as RVO 2.0, the device is surgically implanted in the eyes to improve eyesight — serving as an alternative to glasses and contact lenses. The FDA warning says people who undergo this procedure are at risk of developing cornea hypertrophy, which can affect clear eyesight and cause blurred vision.”
“Accordingly, we recommend that all health care professionals avoid performing the procedure. We also advise on contacting the manufacturer to return unused products and monitor the patients who have been implanted the device and provide them with the necessary treatments,” Al Bastaki added.
Al Bastaki also referred to another circular issued by the Ministry following the warning of the Gulf Health Council regarding the withdrawal of LOBET 100mg; 20ml Ampoule, a medicine produced by Samarath Life Sciences Pvt Ltd and used for the management of high blood pressure. The warning is based on a circular earlier released by the Saudi Food and Drug Authority (Circular No. 9085 - 06/02/1440), due to quality concerns in the product caused by the presence of impurities inside the ampoule.
In case of any side effects resulting from the use of any product or medical device, please contact the Ministry on the telephone numbers 04-2301448, fax 04-2301947 or email pv@moh.gov.ae, in addition to following the circulars issued through the open data page on the Ministry’s website.