miércoles, 16 de marzo de 2016

FDA MedWatch - Eye Drops: FDA Statement - Potential Risk of Loose Safety Seals

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Eye Drops: FDA Statement - Potential Risk of Loose Safety Seals
AUDIENCE: Consumer, Eye Care
ISSUE: 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. See Safety Statement for example photo.
FDA has received reports of six adverse events associated with loose safety seals on eye drop bottles. FDA is in the process of identifying all relevant products and will require a change in the packaging design.
BACKGROUND: 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.
RECOMMENDATION: 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 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 is continuing to investigate this issue and will provide more information when it is available.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including links to the FDA Safety Statement, at:

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