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Raindrop Corneal Inlay Complications May Result in Haze, Vision Problems: FDA

  • Written by: Irvin Jackson
  • 6 Comments

Federal regulators warn that three out of every four patients who received a Raindrop corneal inlay may suffer from hazing and other vision problems, resulting in a recommendation that the eye implants no longer be used.

In a safety communication this week, the FDA raises concerns about a risk of corneal haze associated with the Raindrop Near Vision Inlay, which may result in blurry vision or glare, which may be severe in some cases.

The Raindrop corneal inlay was developed by ReVision Optics, and approved by the FDA in 2016. The implant is a microscopic hydrogel disc meant to improve vision in the place of eyeglasses or contact lenses. ReVision went out of business earlier this year, and the Raindrop inlay is now owned by RVO 2.0, doing business as Optics Medical.

According to the FDA, a post-marketing study of 150 patients found that 75% of patients suffered corneal haze somewhere in their vision within five years of receiving the implant. However, 42% suffered central corneal haze and more than 23% opted to have their Raindrop implant removed. A third of the removals were due to corneal haze.

“At the current time, FDA is recommending that patients should not receive the Raindrop Near Vision Inlay device,” the agency warned patients. “If already implanted with the device, be sure to keep your regularly scheduled appointments with your eye care provider. You should seek sooner evaluation if you have or develop any new or bothersome visual symptoms such as blurry vision or glare. Your physician will determine appropriate treatment options based on the results of an evaluation.”

The FDA also issued recommendations for eye care providers, suggesting they do not implant Raindrop Inlays, carefully monitor patients who have received the device or who have already had it removed, and contact Optics Medical by calling 949-330-6511 for instructions on how to return any unused inlays to the company.

The agency indicates it is working with Optics Medical on a plan to collect the remaining devices and will communicate new information when it is available.

Those who have suffered corneal haze or other vision problems after receiving a Raindrop Near Vision Inlay are urged to issue a report to the FDA through the MedWatch adverse event reporting program.

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6 comments

  1. robert Reply

    hello had rain drop implant installed in my left eye…it never worked from the day it was put in…was back to eye doctor 5 to 8 times with poor vision…was told i have 20/20 …..but i dont think so…sometimes i had to drive with one eye closed because of blur

  2. L Reply

    Robert: I had the exact same experience you did. Zero improvement when I got the inlay. Instead, I gained blurred vision and a terrible glare from lights. I had the inlay removed last week. Did you have yours removed? Did you receive your money back? I’m trying to figure out how to get compensated for a terribly expensive eye surgery that caused me nothing but trouble, but I’ve gotten no refund. I can’t believe there isn’t a class action suit at this point.

  3. M Reply

    I too had the Raindrop inlay implanted in my left eye. From day one the device never worked as presented to the FDA. I was kept on steroids for nearly a year and lived through vision hell. Then at that point (one year) I asked to have it removed. No refund, no compensation. Out all my $$ and the burden of that one year of vision burden.

  4. David Reply

    I also had the Raindrop inlay implanted in my left eye in July 2017. It was never perfect but seemed to get worse after I was taken off steroids. It got to be dangerous on some days just driving. I had 20/20 vision before this, finally had it removed today. I’m hoping my vision returns to normal.

  5. Rosemary Reply

    I had the rain drop implanted in my left eye on Jan 5th 2018. I had a horrible experience. A few hours after surgery I had severe (crying) pain. I couldn’t read my computer for work. The starburst and glares were terrible. I was afraid I would get into an accident while driving, due to object being so distorted. I found myself getting off the road because I couldn’t’ be sure which lane car were in. It was too hazardous for me to drive at night. I could read the eye chart, but the black letters were blurry, light gray in color and distorted. I was told that my vision had greatly improved, impossible!
    My raindrop was removed a year later. I’m experiencing sharp pain in my eye, headaches, twitching of the eye and constant dry eye. I’m back to using eye glasses. I’m concerned this nightmare is not over!!! Why has there not been a class action suit? Ridiculous!

  6. C Reply

    Had raindrop in my right eye over a year ago along with Lasik in left eye to balance vision. Have been back to Dr numerous times for discomfort in eyes, blurred vision and a haziness. My eye sight has gotten so blurry/hazy that I can’t read without readers. I used a reading glass 1.50 before raindrop and now have to use a 2.50. The strain is significant, and painful at times. Doctor also said I have a cataract in right eye. Raindrop being removed on June 25, 2019. Worried eye sight is permanently damaged because of raindrop.

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