[3/15/16] The U.S. Food and Drug Administration (FDA) is warning the public about eye drop bottles that have loose plastic safety seals or tamper evident rings below the bottle cap that may fall onto the eye when the product is used.
The plastic safety seal or tamper-evident ring, also known as a collar, or band, should stay connected to the bottle neck. However, some eye drop bottles are losing the safety seals or rings when consumers tilt or squeeze the bottle to place eye drops into their eyes. A loose safety seal or ring presents a safety risk as it may cause eye injuries.
Consumers and health care providers who have these products should not attempt to remove the ring or seal because there is a potential to contaminate the tip of the dropper.
FDA is in the process of identifying all relevant products and will require a change in the packaging design. FDA strongly recommends when using tamper-evident rings, the bottle/cap design include a positive-retention mechanism similar to those on disposable plastic beverage bottles to prevent the rings from coming off while using the product.
FDA has received reports of six adverse events associated with loose safety seals on eye drop bottles. Patients and consumers who are using prescription or over the counter eye drops and experience this issue or have concerns should contact their health care provider.
FDA encourages health care providers and consumers to report adverse events to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
FDA is continuing to investigate this issue and will provide more information when it is available.
Examples of eye drop bottles with loose safety seals or tamper-evident rings