Unsafe bottles

Some manufacturers keep costs down by skimping on an essential safety feature: the correct bottle.

In early 2023, an inexpensive private label eye drop was linked to infections that have led to 4 deaths and 18 people losing sight. This product and two other eye drops were recalled as a result. The eye drops were packaged in a standard dopper bottle and lacked an effective preservative.

Unfortunately, there are more eye drops still being sold that have the same packaging flaw as Ezricare Artificial Tears. Many of them are sold through e-commerce. They are difficult for consumers to identify. Most of them are not registered with the FDA.

Products of concern

  • FDA-listed: Regener-Eyes Lite, Regener-Eyes Pro

  • Unlisted: See master list and check column B for “Yes” or “Cannot determine”

What makes a bottle unsafe?

Traditionally, eye drops have contained preservatives. Preservatives help to keep eye drops safe from contamination after the bottle is opened.

But preservatives can also be harmful, particularly for people who have eye diseases, including dry eye. So today, many over-the-counter eye drops are preservative-free.

In order to make preservative-free eye drops safe, manufacturers have to use different packaging: instead of the simple familiar screw-top bottle, they put drops in single-use vials which you twist open and discard after use. More recently, new bottles have been developed with contamination prevention devices in the dropper, and some companies have been transitioning to these special bottles.

Unfortunately, an increasing number of companies are selling eye drops that have no preservative yet are packaged in the old style multi-dose bottle.

We call them Frankenstein bottles.

VIDEO: What is a Frankenstein bottle?

Dr. Sandra Brown explains how eye drops without preservatives become contaminated, and why the right packaging for eye drops is such an important safety issue.

Resources

Infographic: Eye drops and preservatives

A close-up view of different types of eye drop packaging and what to look out for.

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Infographic: Practical tips for Amazon shoppers

Three steps of extra scrutiny to help consumers avoid unsafe eye drops on Amazon.

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