Devices

Patients Can Reduce Contact Lens Risk: CDC

A Centers for Disease Control (CDC) study shows that 25% of reports to the FDA Medical Device Report (MDR) database on problems with contact lenses involved patient behaviors that could be modified to reduce the risk of eye damage. The report says that during 2005-2015, a total of 1,075 MDRs describing contact lens-related corneal infections were reported to the FDA database. About 20% of the MDRs described a patient who suffered eye damage.

According to the CDC, about 25% of the MDRs described potentially modifiable factors that might have put the patient at risk for a contact lens-related corneal infection such as sleeping in lenses or wearing lenses longer than for the prescribed period. Other studies have shown that sleeping in contact lenses, whether occasionally or as part of a prescribed wearing schedule for extended-wear lenses, increases the risk for contact lens-related eye infections by six-fold to eight-fold, the report says. In addition, 20% of the analyzed MDRs described eye damage after the contact lens-related infection.

“Although contact lenses are a safe and effective form of vision correction if worn and cared for as directed,” the report concludes, “they pose an infection risk to wearers if not worn and cared for properly. Health promotion activities should focus on informing contact lens wearers of common behaviors that might put them at risk for eye infections, such as sleeping in contact lenses and exposing lenses to tap water, distilled water, or recreational water.”

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