FDA Warns Against Using Raindrop Near Vision Inlay

Troy Brown, RN

October 23, 2018

The US Food and Drug Administration (FDA) today issued an alert about an increased risk for corneal haze in patients with the Raindrop Near Vision Inlay (Optics Medical). The FDA issued the alert after 75% of patients in a postapproval study of the device developed corneal haze.

The FDA is warning eye care providers not to implant the inlays and is working with Optics Medical to recall all remaining inlays from the market. They are no longer being distributed in the United States.

"People who undergo implantation of the Raindrop Near Vision Inlay device are at risk for the development of corneal haze that can affect clear vision. Haze can cause blurry vision or glare by clouding the cornea, or by changing the focusing power of the eye," FDA noted in the alert.

"The impact of haze on the patient’s vision is dependent on the severity of haze and its location in the cornea," the FDA said.

The device is a transparent, curved hydrogel disc tinier than the eye of a needle that is surgically implanted into the cornea of one eye.

The FDA approved the device for ReVision Optics in 2016; RVO 2.0, now doing business as Optics Medical, currently owns the device. The FDA approval followed consideration of data from a prospective, nonrandomized clinical trial among 373 patients in whom the device had been implanted. The postapproval study included 150 of these patients, who were followed for at least 5 years after device implantation.

The 2-year study results for the initial trial found that central corneal haze of any severity occurred in 60 (16.1%) of 373 patients at some time during follow-up. The percentage of patients who experienced two or more lines of vision loss on the eye chart as a result of corneal haze was 1.1% (4 of 373 patients).

At the 2-year follow-up visit, 24 patients (6.4%) had the device removed, and the reason for removal was corneal haze in 29% (7 of 24 implants) of those patients.

Three quarters of the patients (113 of 150 patients) developed haze at any location of the cornea and 42% (63 of 150 patients) developed central cornea haze. The first episode of corneal haze developed 60 months after device implantation in 22 patients. Three (2%) of 150 patients lost two or more lines of vision on the eye chart as a result of corneal haze — a higher percentage than that seen during the original clinical trial.

Steroid Eye Drops Used to Treat Haze

Thirty-one (20.7%) of the 150 patients in the postapproval study received steroid eye drops at some point during the study and 29 (23.7%) of 122 patients in whom the device was still implanted received steroid eye drops for corneal haze. Of the 29 patients, eight received steroids for at least 3 months, and an additional 10 patients were still receiving active treatment at the time the results were reported or left the study while receiving active treatment.

Some patients did not experience resolution of the corneal haze from the steroid eye drops, necessitating removal of the device.

Steroid eye drops are frequently used to treat corneal haze; however, they are linked to an increased risk for elevated eye pressure, which is a possible indicator of glaucoma. The drops have also been associated with an increased risk for cataract.  Some patients in the follow-up study subsequently experienced a recurrence of haze after successful treatment.

Over time, corneal haze has caused a significant number of patients to have the device removed. To date, 35 (23.3%) of the 150 patients have had the implant removed after they left the original clinical trial or during the postapproval study. The device was removed as a result of corneal haze in 11 (31%) of 35 patients and as a result of unresolved inflammation (which may also include patients with corneal haze) in 10 (28%) of 35 patients.

"It is important to note that there was one patient who first developed haze 6 months after removal of the device. In addition, some patients continued to have corneal haze even after the device was removed. This study is ongoing and patient follow-up is continuing," the FDA said in the alert.

Recommendations for Clinicians

The FDA is advising clinicians not to implant the Raindrop Near Vision Inlays. Contact Optics Medical via phone (949-330-6511) to receive instructions on returning any unused inlays to the company.

The postapproval study is ongoing; eye care providers should be aware of new data from the study, which is finding high rates of corneal haze in patients who still have the device and in those who have had it removed, and a rising rate of device removal.

Observe patients closely for the development of corneal haze, including those whose device has been removed, the agency advises.

The FDA is developing a plan with Optics Medical to collect any remaining implants that have already been distributed. The agency will continue to collect and evaluate data related to the device and corneal haze and will issue new information as needed.

The FDA encourages prompt reporting of adverse events to enable the FDA to identify and improve its understanding of risks related to medical device use. Clinicians can file a voluntary report of suspected or confirmed problems with this device through MedWatch, the FDA's Safety Information and Adverse Event Reporting program.

For questions about this alert, contact the Center for Devices and Radiological Health's Division of Industry Communication and Education of the FDA at dice@fda.hhs.gov, 800-638-2041, or 301-796-7100.

More information about this alert is available on the FDA website.

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