Primary Eyecare and Optical of Meridian Alerts Patients to Opternative FDA Complaint

Primary Eyecare and Optical of Meridian Alerts Patients to Opternative FDA Complaint

MERIDIAN, Miss., Sept. 11, 2016 (GLOBE NEWSWIRE) — Opternative, a “vision test” app, entered the market without the necessary approval to guarantee its use as a safe and effective tool to diagnose vision problems, reports Primary Eyecare and Optical of Meridian. The American Optometric Association has recently filed a complaint against the marketing and use […]

MERIDIAN, Miss., Sept. 11, 2016 (GLOBE NEWSWIRE) — Opternative, a “vision test” app, entered the market without the necessary approval to guarantee its use as a safe and effective tool to diagnose vision problems, reports Primary Eyecare and Optical of Meridian. The American Optometric Association has recently filed a complaint against the marketing and use of Opternative. Patients who want to maintain their eye health should continue the practice of annual in-person eye exams.

The American Optometric Association (AOA) has lodged an FDA complaint against Opternative. Without any FDA review of the “vision test” app from Opternative, there may be significant health risks to the general public. The complaint was submitted as of April 4th with the argument that marketing of Opternative without the support of federal approval violates the Food, Drug and Cosmetic Act (FDCA). Inventors filed a patent application but the product has not received needed premarket approval before being marketed to the public. The AOA requests that the device be properly reviewed by the FDA before potentially reentering the market. Eye doctors are worried about the potential negative impact of unproven products that can place patients at risk.

Dr. Steven A. Loomis, O.D., AOA president stated:

“Instead of apps or device of the moment that promise everything but deliver inadequate or incomplete information, Americans want new health care technologies, like those incorporated into my practice and optometry practices across the country, that strengthen the doctor-patient relationship and help make people healthier. In this era of rapid health care change, our AOA and state associations are on the leading edge of the fight for very basic health and safety standards, and a future in which health care efficiency is based on gains in quality and improved patient outcomes.”

Dr. Minh Duong, an optometrist at Primary Eyecare and Optical of Meridian says that, “My team and I support the initiative of the AOA and warn our patients of using Opternative, an unproven technology that could potentially cause risks to users. This “vision app” technology requires individuals to competently use a number of self-administered tests that in some instances do not follow customary vision practices. Patients should see their eye doctor for accurate vision exams using proven, approved and standardized technologies to maintain their vision and identify any problems.”

Dr. Minh Duong offers vision services at Primary Eyecare and Optical of Meridian to the residents of Meridian and the surrounding communities in Mississippi and Alabama. This family practice helps children and adults with eye care and vision needs. Services include eye exams, Optomap retinal imaging, eye disease care, vision testing, contact lens exams, and pre-operative and post-operative care.

Call (601) 485-2020 to learn about in-person vision exams or visit http://primaryeyecarems.com/ for more details on their optometry services.

CONTACT: Primary Eyecare and Optical of Meridian, (601) 485-2020

Source: Health Care

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