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Loose safety seals on eye drop bottles a hazard, FDA warns

March 23, 2016

Silver Spring, MD – The Food and Drug Administration is cautioning consumers about eye drop bottles that have loose plastic safety seals or tamper-evident rings that can fall into the user’s eye.

The safety seals or rings – also called collars or bands – under the cap can disconnect from the bottle when consumers tip or squeeze the bottle to use the drops, potentially causing an eye injury. People who experience this issue should contact their doctor, FDA advises. Consumers and doctors also can contact FDA’s MedWatch Adverse Event Reporting program.

FDA encourages consumers to avoid removing the seal or ring from the bottle because the tip of the eye dropper can become contaminated.

Six incidents involving loose safety seals on eye drop bottles have been reported to FDA. The agency states it is examining products and will mandate a change in packaging design.