Safety warning for the medical device "Raindrop Near Vision Inlay".
With this letter, the Federal Office for Safety in Health Care (BASG) draws attention to a possible hazard posed by the product "Raindrop Near Vision Inlay" from the manufacturer ReVision Optics. The product "Raindrop Near Vision Inlay" is a medical device for the treatment of presbyopia. It is implanted in the cornea of an eye and causes a change in the shape of the cornea, which is intended to improve sharp vision in the vicinity. According to a warning published by the U.S. Food and Drug Administration (FDA) (see link below), data from an ongoing study show that 75% of study participants had corneal opacity.
Based on the information currently available, it can be assumed that the manufacturer of the products in question (ReVision Optics) no longer exists. In the case of patients who have been implanted with implants from the manufacturer mentioned, health care institutions should consider and evaluate a possible connection with the described defect pattern. In any case, no further implantation of the products is required.
Furthermore, we would like to remind you once again of the reporting obligation. According to § 70 MPG, any incident that could lead to a serious impairment of health or death of a patient, user or third party must be reported immediately to the Federal Office for Safety in Health Care.
You can find the registration forms online at www.basg.gv.at/medizinprodukte/formulare/mp-zwischenfall/ Patients affected are advised to contact their attending physician if necessary.
|Medical devices||Raindrop Near Vision Inlay|