People who have undergone implantation of the Raindrop Near Vision Inlay (Optics Medical) are at risk for developing corneal haze, according to a report from the FDA. The agency advises surgeons to no longer implant the device, which was removed from the market earlier this year. Currently, the FDA is working with Optics Medical to have all remaining product on the market recalled.
From a post-approval study of 150 patients, 35 to date have had their device removed either during the post-approval study or after they left the original clinical study, with 11 developing corneal haze. Some patients continued to have the finding even after the device was removed. This study is ongoing and patient follow-up continues.
The FDA advises that those already with the device implanted should continue following up with their practitioner and seek evaluation if they develop blurry vision or glare that is bothersome. Providers should monitor carefully both patients with the implant and those with the device explanted for any development of corneal haze.
“There is no need to alarm the patient,” advises Derek Cunningham, OD, director of optometry at Dell Laser Consultants in Austin, TX. “Just let them know that this implant, or the procedure that was used to put the implant in, is now being found to cause corneal haze in some patients.” Dr. Cunningham recommends practitioners maintain routine eye checks, specifically corneal exams, every six months.
According to Dr. Cunningham, signs and symptoms that could be indicative of corneal haze include opacification of the stroma, especially in the collagen adjacent to the corneal pocket, as well as unexplained vision decline. Mild haze will often have patients complaining of poor quality of vision despite a relatively unchanged prescription and acuity that seems "good.” Patients will also complain of increased glare and halo at night.
While topical steroids are commonly used to treat corneal haze, the FDA notes their association with intraocular pressure rise and cataract formation. Dr. Cunningham believes steroid use to be the standard of care and feels the potential benefit of resolving the corneal haze justifies the low-risk side effects in this use, but recommends greater vigilance whenever prescribing these agents.
Regarding explantation, Dr. Cunningham believes it would be reasonable to discuss removing the inlay if the patient is unhappy with their vision or experiences unresponsive/recurrent haze. Still, he does point out that haze remains a possibility even if the implant is removed due to mechanical disruption of collagen from the procedure.
|United States Food and Drug Administration. Increased risk of corneal haze associated with the raindrop near vision inlay: FDA safety communication. https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm623973.htm. Published October 23, 2018. Accessed October 25, 2018.|