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FDA warns public about loose plastic safety seals on eye drop bottles
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The FDA is warning the public about eye drop bottles that have loose plastic safety seals or tamper evident rings below the bottle cap, according to a press release from the FDA.
Some eye drop bottles are losing the safety seals or rings when consumers are tilting or squeezing the bottle to place eye drops into their eye, causing eye injuries.
The FDA has received six adverse event reports associated with the loose plastic safety seals and is in the process of identifying products that will require a change in design.
Consumers are advised when using tamper-evident rings to “include a positive-retention mechanism similar to those on disposable plastic beverage bottles to prevent the rings from coming off,” the release said.
The FDA will continue to investigate and provide further information. Health care professionals and patients are encouraged to report adverse events and side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
For more information:
FDA. Eye Drops: FDA statement – Potential risk of loose safety seals. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm490862.htm. Posted March 15, 2016. Accessed March 16, 2016.