Regulatory/Legislative News

After receiving a warning letter from the FDA on Aug. 16 citing “significant violations” related to two Regener-Eyes ophthalmic products, the company has implemented several improvements to address the concerns.

KIAWAH ISLAND, S.C. — In this Healio Video Perspective from Kiawah Eye, Jeffrey J. Kimbell, president and CEO of Jeffrey J. Kimbell and Associates, explains how the federal government and elections affect the eye care community.

The FDA has approved Lumify Preservative Free eye drops for the treatment of ocular redness due to minor eye irritations, according to a press release from manufacturer Bausch + Lomb.

The U.S. Department of Justice filed a complaint under the False Claims Act against Regeneron Pharmaceuticals, according to a press release.

The FDA has granted breakthrough device designation to SightGlass Vision’s diffusion optics technology spectacle lenses, which are designed to slow myopia progression in children.

The FDA has issued a warning to consumers not to purchase or use South Moon, Rebright or FivFivGo eye drops because of possible contamination and risk for eye infection.

Kilitch Healthcare India Limited has voluntarily recalled 25 over-the-counter eye drop products after the FDA warned of unsanitary conditions and potential safety concerns, according to a company press release.

After receiving a warning letter from the FDA, the online retailer Amazon removed seven unregulated eye drop products from its website.

The FDA has approved Eyenovia’s Mydcombi ophthalmic spray for inducing mydriasis, the company announced in a press release.