Patients with Raindrop near vision inlay at risk for corneal haze

The FDA released a safety communication recommending that patients not receive the inlay.

The FDA released a safety communication regarding the Raindrop near vision inlay after a post-approval study found 75% of patients with the inlay developed haze in any location within the cornea.

The FDA recommended that the Raindrop near vision inlay, brought to market by the now defunct ReVision Optics, not be implanted in any patients moving forward, and those who have the inlay should undergo increased monitoring with their physician. The FDA is working with the device owner, RVO 2.0, which is doing by business as Optics Medical, to collect devices that have already been distributed.

“Patients with the inlay can expect that they’ll be followed closely. I tell my patients that removing the implant is probably the lowest risk course of action but will remove any benefit they have gained from the implant. Most patients have done well with them, but there is a significant percentage of late problems, and not all of those problems seem to be reversible when the implant is removed,” OSN Cataract Surgery Section Editor John A. Hovanesian, MD, FACS, said.

Corneal haze rates

The FDA initially approved the inlay in 2016 based on the evidence in a prospective, nonrandomized clinical study of 373 patients with the device. At 2 years’ follow-up, 16.1% of patients with the inlay had experienced central corneal haze at some time during that period.

A post-approval study followed 150 patients from the original study for at least 5 years after surgery. At the most recent interim data, 42% of patients reported central corneal haze and 75% of patients reported the presence of haze at any location within the cornea. The device was removed in 35 patients, with the reason attributed to corneal haze in 11 patients (31%) and to unresolved inflammation, possibly including cases of corneal haze, in 10 (28%), according to the FDA communication. One patient developed corneal haze 6 months after having the inlay was removed, and some patients continued to experience corneal haze after removal of the device.

“There is risk either way in leaving it in or taking it out. Generally, I tell patients that the risk is less if it’s removed. We as physicians must give our patients our opinion, so it’s really individualized patient by patient. In general, patients who have had zero problems with the inlay aren’t likely to have future problems, but we never know. But patients who have had more problems, such as requiring steroids to control their haze, are more likely to have future problems and we might steer them more toward removal,” Hovanesian said.

Strategies for removal

If removal is an option, the surgeon should have a backup plan for the patient. An alternative such as a refractive lens exchange or monovision PRK after achieving post-removal stability might restore uncorrected reading vision, Hovanesian said.

He noted it is important to distinguish the Raindrop inlay from the FDA-approved Kamra inlay (CorneaGen). The Kamra inlay has not had these types of complications and has been successfully implanted by surgeons in thousands of patients throughout the world.

“Surgeons should not generalize these kinds of problems. They probably relate to the material of the Raindrop implant, which is a hydrogel. The Kamra is not the same type of material and doesn’t have similar problems. ReVision Optics, now under the ownership of Optics Medical, is ultimately seeking to bring the Raindrop implant back on the market. It will probably involve a new implant material and probably have a much better safety record. Don’t write off the whole category of implants because of this warning. For a lot of patients, they’re still a good option,” he said. – by Robert Linnehan

Reference:

Increased risk of corneal haze associated with the Raindrop near vision inlay: FDA safety communication. www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm623973.htm. Published Oct. 23, 2018. Accessed Dec. 10, 2018.

For more information:

John A. Hovanesian , MD, FACS, can be reached at Harvard Eye Associates, 24401 Calle De La Louisa, Laguna Hills, CA 92653; email: drhovanesian@harvardeye.com.

Disclosure: Hovanesian reports he was an investigator for ReVision Optics and is currently an investigator for Optics Medical and a consultant for CorneaGen.

 

The FDA released a safety communication regarding the Raindrop near vision inlay after a post-approval study found 75% of patients with the inlay developed haze in any location within the cornea.

The FDA recommended that the Raindrop near vision inlay, brought to market by the now defunct ReVision Optics, not be implanted in any patients moving forward, and those who have the inlay should undergo increased monitoring with their physician. The FDA is working with the device owner, RVO 2.0, which is doing by business as Optics Medical, to collect devices that have already been distributed.

“Patients with the inlay can expect that they’ll be followed closely. I tell my patients that removing the implant is probably the lowest risk course of action but will remove any benefit they have gained from the implant. Most patients have done well with them, but there is a significant percentage of late problems, and not all of those problems seem to be reversible when the implant is removed,” OSN Cataract Surgery Section Editor John A. Hovanesian, MD, FACS, said.

Corneal haze rates

The FDA initially approved the inlay in 2016 based on the evidence in a prospective, nonrandomized clinical study of 373 patients with the device. At 2 years’ follow-up, 16.1% of patients with the inlay had experienced central corneal haze at some time during that period.

A post-approval study followed 150 patients from the original study for at least 5 years after surgery. At the most recent interim data, 42% of patients reported central corneal haze and 75% of patients reported the presence of haze at any location within the cornea. The device was removed in 35 patients, with the reason attributed to corneal haze in 11 patients (31%) and to unresolved inflammation, possibly including cases of corneal haze, in 10 (28%), according to the FDA communication. One patient developed corneal haze 6 months after having the inlay was removed, and some patients continued to experience corneal haze after removal of the device.

“There is risk either way in leaving it in or taking it out. Generally, I tell patients that the risk is less if it’s removed. We as physicians must give our patients our opinion, so it’s really individualized patient by patient. In general, patients who have had zero problems with the inlay aren’t likely to have future problems, but we never know. But patients who have had more problems, such as requiring steroids to control their haze, are more likely to have future problems and we might steer them more toward removal,” Hovanesian said.

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Strategies for removal

If removal is an option, the surgeon should have a backup plan for the patient. An alternative such as a refractive lens exchange or monovision PRK after achieving post-removal stability might restore uncorrected reading vision, Hovanesian said.

He noted it is important to distinguish the Raindrop inlay from the FDA-approved Kamra inlay (CorneaGen). The Kamra inlay has not had these types of complications and has been successfully implanted by surgeons in thousands of patients throughout the world.

“Surgeons should not generalize these kinds of problems. They probably relate to the material of the Raindrop implant, which is a hydrogel. The Kamra is not the same type of material and doesn’t have similar problems. ReVision Optics, now under the ownership of Optics Medical, is ultimately seeking to bring the Raindrop implant back on the market. It will probably involve a new implant material and probably have a much better safety record. Don’t write off the whole category of implants because of this warning. For a lot of patients, they’re still a good option,” he said. – by Robert Linnehan

Reference:

Increased risk of corneal haze associated with the Raindrop near vision inlay: FDA safety communication. www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm623973.htm. Published Oct. 23, 2018. Accessed Dec. 10, 2018.

For more information:

John A. Hovanesian , MD, FACS, can be reached at Harvard Eye Associates, 24401 Calle De La Louisa, Laguna Hills, CA 92653; email: drhovanesian@harvardeye.com.

Disclosure: Hovanesian reports he was an investigator for ReVision Optics and is currently an investigator for Optics Medical and a consultant for CorneaGen.