Devices

Pull LASIK Off Market: Waxler

Retired CDRH branch chief Morris Waxler, who voted to approve LASIK eye surgery when he worked for the agency, now tells CBS News the vote was a mistake and LASIK should be taken off the market. “I reexamined the documentation … and said, ‘Wow, this is not good,” Waxler told the network. He said his own analysis of industry data shows complication rates between 10% and 30%.

In 2011, Waxler petitioned FDA for a voluntary recall of LASIK. The agency denied the petition three years later and told CBS it “has not found any new safety concerns associated with LASIK devices.”

Waxler’s comments appear as part of a lengthier CBS News piece reviewing some of the patient claims of complications with the surgery.

Earlier this year Waxler called on FDA to stop deceiving the public about adverse events associated with a laser procedure called the small incision lenticule extraction (SMILE), that is intended to reduce or eliminate nearsightedness in certain patients 22 years of age or older. SMILE was approved in 2016 for Carl Zeiss Meditec’s VisuMax Femtosecond Laser.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome