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FDA Recalls Online Vision Test

The company was formerly known as Opternative.

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The Visibly Online Refractive Vision Test has been recalled by the U.S. Food and Drug Administration.

The test by Visibly, formerly known as Opternative, “is being recalled since the firm has not received authorization from FDA to market the product,” according to a notice from the FDA.

The FDA states that the test has had worldwide distribution, including including Arizona, California, Delaware, Florida, Illinois, Missouri, Nevada, New York, Ohio, Pennsylvania, Texas, Washington and Utah.

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Healio.com notes that the FDA sent a warning letter to Opternative in 2017. The news site reports that the company did not respond to a request for comment on the recall.

The American Optometric Association states that in April 2016, it “issued a formal complaint to the FDA that emphasized Opternative’s lack of premarket approval (PMA) prior to marketing. The organization says it “indicated that the test should be removed from the market altogether.”

AOA states that it had concerns about “the potential for inaccurate prescriptions, missed diagnoses of serious and general health conditions, and the creation of a prescription with little input from an eye doctor.”

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“Optometrists and other physicians know that eye exams are essential care and that new health technologies must always enhance the doctor-patient relationship and help deliver improved outcomes,” said AOA President Barbara L. Horn, OD. “They must also comply with the law — that’s exactly what the AOA and our state associations have insisted on through the information we provided to the FDA and other agencies in this matter, and we’re proud that it appears to have made a difference.”

The action is a Class 2 recall, meaning the FDA considers it “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

The FDA explains that recall is “a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.”

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Eyecare Pros Rate Their Happiness with Work … and Life

Results of the 2019 Big Survey are in. Here’s a sample.

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IN INVISION’S FIRST annual Big Survey, we asked ECPs their overall satisfaction with their professional lives … as well as their overall satisfaction with life.

The good news? As a group, ECPs are happy with their careers, reporting an average of 7.9 on a scale from 1 to 10 (1 being “extremely dissatisfied” and 10 being “totally satisfied”). The better news? You’re happier with your life as whole. The average response there was 8.2 on a scale from 1 to 10.

The happiest among you in both areas? Owners of eyewear boutiques without an affiliated OD.

The 2019 Big Survey was conducted from August to October and attracted responses from more than 500 American ECPs. Look out for all the full results in the November/December issue of INVISION.

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Everything Is Bigger in the South, Including Eyecare Practices

Results of the 2019 Big Survey are in. Here’s a sample.

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SEEMS THAT EVERYTHING is bigger in the South, according to INVISION’s Big Survey. The Northeast is home to a disproportionate number of smaller vision businesses, while bigger practices are most common in the South. Thirty-one percent of the small stores/practices in our survey — those with less than 1,500 square feet — were in the Northeast, while 41 percent of the big ones — those over 3,000 square feet — were in the South. These large operations were mostly either private practices with a focus on retail or medical model private practices with a small dispensary.

How big is your (main) location?

Less than 500 sq. ft
4%
500-999 sq. ft.
10%
1,000-1,499 sq. ft.
24%
1,500-1,999 sq. ft.
17%
2000-2499 sq. ft.
15%
2500-2999 sq. ft.
11%
3000-3,999 sq. ft.
8%
4,000-5000 sq. .ft.
6%
More than 5000 sq. ft.
5%

The 2019 Big Survey was conducted from August to October and attracted responses from more than 500 American ECPs. Look out for all the full results in the November/December issue of INVISION.

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Which State Has the Hardest-Working ECPs? And Which State Has the Weirdest? INVISION’s Big Survey Tells All!

Results of the 2019 Big Survey are in. Here’s a sample.

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INVISION’S FIRST ANNUAL Big Survey found out a lot of interesting information about the American ECP… even our Canadian friends to the north weighed in. We started with the basics, and they did not disappoint! Want to know which state has the most female owners, or which one has the weirdest ECPs? Here are few quick takes from the 2019 survey:

Californian ECPs were the least likely to own their places of business, with 82 percent renting.

Kansans were most likely to be open on Sunday with one in four stores and practices open on this traditional “rest” day.

They don’t take kindly to strangers asking questions in South Dakota. South Dakota, Louisiana and New Mexico were the only states not represented in our survey.

Michigan ECPs are some of the hardest working in the industry: 25 percent work more than 50 hours a week.

Florida had the most male owners and managers in our survey at 76 percent. Washington state had the most female owners at 86 percent.

Connecticut was tops for self-declared weirdness with ECPs there giving themselves an average score of 8.2 out of 10 on our weirdness scale.

The 2019 Big Survey was conducted from August to October and attracted responses from more than 500 American ECPs. Look out for all the full results in the November/December issue of INVISION.

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