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Increased occurrence of corneal haze after implantation of the Raindrop Near Vision Inlay (FDA Safety Communication)

Reference: 14066/18

The US-American Food and Drug Administration (FDA) has published a Safety Communication on their website and informs about new clinical data concerning the Raindrop implant. The device is a corneal inlay (corneal implant) and may be used for improving near vision. Implanting the Raindrop Near Vision Inlay by the manufacturer ReVision Optics, which according to our information no longer exists, has led to an increased occurrence of corneal haze.
The cited study shows that 75 per cent of 150 enrolled patients suffered from corneal haze. In 42 per cent of patients, the corneal haze has been present in the central region of the cornea. Treatment with steroid eye drops (such as corticosteroids; BfArM comment) has been successfully used. Recurrence of haze at a later time are possible.
Therefore, the BfArM strongly recommends not implanting the Raindrop Inlay any more. Patients already implanted with the Raindrop Inlay should visit their attending physicians for follow-up appointments regularly.

Please visit the FDA website for further information:
Increased Risk of Corneal Haze Associated with the Raindrop Near Vision Inlay: FDA Safety Communication.

The German Society for Cataract & Refractive Surgeons (GSCRS) has published a statement regarding the topic:
http://www.dgii.org/uploads/stellungnahmen/Stellungnahme-Raindrop_2018-12-06.pdf.

In case of questions please contact:

Federal Institute for Drugs and Medical Devices
Medical Devices Division
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

Telephone +49 228-207 3202 (Non-active medical devices)
Facsimile +49 228-207 5300
e-mail: md-vigilance@bfarm.de

Date 2019.01.07