Increased risk of corneal haze in patients implanted with Raindrop Near Vision Inlays

Swissmed Pte Ltd would like to inform healthcare professionals of an increased risk of corneal haze caused by the ophthalmic implant Raindrop Near Vision Inlays. The post-approval study mandated by US Food and Drug Administration showed that 75% of 150 enrolled patients with implantation developed corneal haze. In 42% of patients, the corneal haze has been present in the central region of the cornea. Healthcare professionals are advised to stop the use of the affected inlays and to monitor patients who have the inlays implanted or have previously had the devices explanted for the development of corneal haze. Please refer to the letter for details.