Raindrop Corneal Inlay Recall Issued Over Corneal Haze Problems

Amid concerns about the risk of complications with Raindrop corneal inlay procedures, RVO 2.0 Inc. is recalling nearly 3,000 corrective vision implants, due to a risk of corneal haze and other vision problems.

A Raindrop Near Vision Inlay recall was announced by the FDA on March 5, including a warning that indicates the implant may pose a serious risk for consumers and may impair their vision.

The FDA classified the action as a class I recall, which is the most serious type of medical device recall, reserved for products that may result in serious injury or death.

The Raindrop Near Vision Inlay is a transparent, curved hydrogel disc that is smaller than the eye of a needle. It is designed to be surgically implanted into the cornea of the eye to improve near vision and offer an alternative to eyeglasses or contact lenses. The Raindrop Inlay reshapes the central region of the cornea to offer an area in the eye with increased power for focusing on near objects and improve vision overall.

RVO 2.0 indicated data from the post-approval study concludes there is an increased risk of corneal haze. Corneal haze is a type of cloudiness in the cornea caused by inflammation. The haziness can impair the vision of the consumer with the inlay.

The FDA issued a safety warning about the issue on October 23, 2018, indicating that doctors should stop using the medical device because three out of every four patients suffered from vision problems after having the inlay implanted, according to a post-marketing study.

An “Urgent Medical Device Recall” letter was sent to customers on November 13, 2018, instructing customers to stop implanting the Raindrop Inlay and return unused products.

Patients who have the inlay implanted in their eye should contact their doctor and receive an evaluation to determine how to proceed. If they experience any visual symptoms, like blurry vision or glare, they should seek an evaluation sooner.

The class I recall affects all lots of the Raindrop Near Vision Inlay model number RD1-1 distributed August 1, 2016, to March 7, 2018.

For more information about the recall or the device contact Optics Medical at (949) 330-6511. Any side effects related to the Raindrop Inlay should be reported to the FDA MedWatch Adverse Event Reporting Program immediately.

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  1. Chuck Reply

    Just went to Dr yesterday and found that the implant is cloudy. Prescribed Durasel eye drops every 4 hours with a follow up with the actual surgeon in two weeks. Waiting on the call to schedule that.
    I noticed approx 6 months ago that my implanted eye felt like there was something in the eye and I was having issues with distance sight.
    I’ve had all of one day to try to digest all this and am not happy…obviously.

  2. Kendra Reply

    Have u had ur Raindrop lens removed ?

    Mine was implanted in Jan 2018 and removed 4 months ago. If so what was the outcome ?

  3. L Reply

    I have had a Raindrop Inlay 2 years. I’ve complained of blurry vision in that eye since the day it was implanted. I’m debating on getting it removed. Dr says he does not see haziness and implant is working as expected. I’m so confused and anxious about what to do. At this time, I only use glasses for nighttime driving and dark environments. Are you happy with your vision after getting the implant removed?

  4. Roxanne Reply

    My mother had Raindrop implanted. The phone number to contact here is disconnected, and the doctor who implanted is now referring her out even though they themselves have removed all other implants they have previously put in.
    I need to know what my mother can do and this instance.

  5. Kendra Reply

    Yes it’s removed by Kellogg eye center University of Michigan – Vast improvement. Dr nellasamby. Best choice made yet!

  6. Russ Reply

    It was almost exactly 2 years since my Raindrop was implanted that it needed to be removed. It was implanted in January 2018 and removed January 2020. I started getting corneal hazing approximately 3 months ago. Dr. tried clearing it up with Durezol 0.05% drops. I have blurry vision in that eye now I hope it clears up. Dr. says it should improve after healing from removal procedure. I guess time will tell…..

  7. Chris Reply

    Can they be sued for this? I now have the glaze in my eye and doctor keeps prescribing eye drops and they even have the gall to keep billing me for the removal of the recalled device.

  8. Neal Reply

    Surgery to implant Raindrop 2-2018. After 6 months haze set in. Have been on 3 different steroids since witwithout clearing haze. Also have to use pressure med to keep numbers down. Some blurry vision but cost of ongoing follow up and prescription drops has driven me to think inlay must come out. Surgeon leaving it up to me to decide but has quoted $1,300 for removal. Since this is an FDA Class 1 Recall Status should I have to pay to remove a recalled device?

  9. Ervin Reply

    I had the raindrop done 6 months later started noticing some minor cloudiness so I want back to the eye doctor. They gave me some eye drops for dry eye. I had the inlay removed September of 2019. I have a permanent scare in my right eye best vision is 20/40

  10. Carol Reply

    I had mine implanted in Jan 2017 and removed Oct 2019 due to haze and cloudy vision. I’ve gone thru several rounds of eye drops with no change. I am reluctant to keep doing this as steroid eye drops can cause cataracts in the future. At my last appointment my dr told me I may need laser surgery in the future. I got a second opinion who agreed and is sending me to a corneal specialist 3 hours away.
    I am annoyed that this was recalled in Oct 2018 and I was not notified. If I had it removed sooner perhaps the damage would not be as bad as it is. I am annoyed that I am expected to pay for the treatment of this. I know the company that produced the raindrop went out of business but there should be some sort of bond to cover issues like this. I just don’t know how to find any info

  11. Deborah Reply

    I had the raindrop implant in May 2017 . Have not experienced the corneal hazing . But I now have no distance vision in that eye . I can barely read the top line on the eye chart . Before the surgery , I never had any problem with distance vision. I was only looking to improve my close up vision. Well that didn’t work either . For about 3 months after the surgery I could read without reading glasses , then my vision went back to the same as it was before the procedure . So now I have no distance vision in that eye , completely blurry , and no improvement in my close up vision . Still need reading glasses . But what really concerns me is the loss of distance vision . Raindrop was touted as a Near vision restoration procedure . Loss of distance vision was a side effect I wasn’t prepared for ! I also was not notified of the recall . I found out on my own . Don’t want to make a bad situation any worse . So I haven’t done anything about having it removed . Not really sure what to do . No advice from the eye surgeon . Would appreciate advice from others . Thank you .

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