MAR 16, 2016
Some eye drop bottles are losing plastic safety seals or tamper evident rings below the bottle cap when consumers tilt or squeeze the bottle to instill eye drops, causing eye injuries.
The FDA has received reports of 6 adverse events associated with loose safety seals, and is in the process of identifying all relevant products that will require a change in the packaging design. Tamper-evident rings usually include a positive-retention mechanism similar to those on disposable plastic beverage bottles to prevent the rings from coming off.
Consumers are also advised not to attempt to remove the ring or seal because there is a potential to contaminate the tip of the dropper, according to the press release.
Adverse events or side effects related to the use of these products may be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program, either online, by mail or by fax.