FDA Statement: Eye Drops-Potential Risk

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FDA MedWatch – Eye Drops: FDA Statement – Potential Risk of Loose Safety Seals
03/15/2016

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…

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