Optics Medical—Raindrop Near Vision Inlays: Use May Be Associated with Development of Corneal Haze

October 31, 2018 | Risk Management News

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​​​ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Device Alerts. For more information contact us at clientservices@ecri.org.

In an October 23, 2018, Safety Communication, FDA states that patients implanted with the above inlays may be at increased risk for corneal haze, a type of cloudiness in the cornea caused by inflammation. FDA is advising that eye care providers not implant Raindrop inlays and is working with Optics Medical to have all remaining product on the market recalled. Raindrop Inlays are no longer being distributed in the U.S. The manufacturer has not confirmed the...

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