1. Scleral filling solution sterility is critical.

At the Dry Eye Shop, the safety of preservative-free saline solutions for scleral lens filling is a very high priority.

... Because these solutions do not contain preservatives.

As we all know, scleral filling solutions cannot have preservatives because they are in some degree toxic to the cornea. However, the flip side of "preservative-free" is that these solutions don't have the ability to neutralize pathogens (kill bugs!). So, if some kind of bacteria is ever accidentally introduced during the manufacturing and packaging process, you could end up literally dripping bacteria into the bowl of your scleral lens.

... Because the people using these solutions have vulnerable eyes.

Scleral lenses - and therefore scleral filling solutions - are used primarily by people with corneal diseases. Common indications for scleral lens use include keratoconus, Stevens Johnson Syndrome, Ocular Graft-v-Host Disease, Sjögrens Disease and non-Sjögrens Dry Eye Disease. These are people with eyes that are already vulnerable. They may not be as able as others to fight off pathogens introduced to the eyes.

... Because these solutions are applied to the eyes.

Liquid products meant for use on or in the eye are inherently higher risk than other types of drugs.

When the FDA sends Warning Letters to manufacturers, those letters always include this language:  "...ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses."

... Because these solutions have prolonged contact with the eye.

Scleral lenses hold the filling solution against the eye for long periods. If the solution is contaminated, this could significantly increase the risk of harm to the eye.

 

2. Safety issues for sterile ophthalmic solutions are on the rise.

4 people died and 18 people went blind from an unpreserved eye drop in 2022-2023.

Ezricare Artificial Tears, a cheap generic for Refresh Liquigel that was popularized on Amazon and also distributed to many healthcare facilities, was apparently both misformulated (its preservative was not effective) and contaminated at the factory, causing extensive harm through treatment-resistant Pseudomonas infections. This tragedy ushered in a new era of scrutiny for OTC eye drops.

80 OTC eye drops have been recalled since January 2023.

Since the Ezricare tragedies, additional OTC eye drop recalls have included many brands of both specialty and generic eye drops.

23 OTC eye drop manufacturers have received FDA Warning Letters since January 2023.

FDA Warning Letters are not slaps on the wrist for minor infractions. They are a very serious form of enforcement action and are typically not issued until after multiple site inspections have resulted in serious citations which the company has failed to satisfactorily address on a sustained basis, often spanning many years.

1 scleral filling solution has been recalled twice.

1 lot of Nutrifill brand saline was recalled in 2021 and 6 lots were recalled in 2025. Production was discontinued after the 2025 recall. More than 30 infections and 14 corneal ulcers have been reported in connection with the solution since the second recall.

 

3. There is no effective advance warning system for OTC ophthalmic solution risk trends.

Adverse event reporting works for prescription drugs

Drug makers have very strictly enforced protocols to ensure reporting of reactions and side effects that are suspected of being linked to the drug in question. Of course, not every reported problem was actually caused by the drug, but as the numbers accumulate, it becomes possible to detect trends over time. In general, pharmaceutical companies are extremely compliant with reporting rules. These reports are logged in a publicly searchable database called FAERS. That includes reports about prescription eye drops. For example, as of this writing (January 2026), Xiidra had 13,443 adverse event reports since its launch in 2017; Restasis had 17,933 since its launch in 2003; and Miebo had 1,051 since its launch in late 2023.

But not for OTC eye drops

Laws notwithstanding, over-the-counter eye drop reactions or issues generally do not get reported - even though OTC eye drops are used by far more people than prescription eye drops. 

Ezricare Artificial Tears, which was so tragically linked to 4 deaths, 18 cases of blindness and dozens of treatment-resistant Pseudomonas infections, had zero adverse events reported for it or even for any similar eye drops until after the CDC announced the first death. (Since it was a generic, the AEs were not listed under the brand name Ezricare.)

And even less for scleral filling solutions

Preservative-free saline solutions are even less likely to have documented adverse event reports, and those reports are more difficult to find. All contact lens solutions are regulated as devices, and they live in a different database (MAUDE) which organizes them differently and much less consistently. As of this writing, there is 1 adverse event report (in 2020) for Scleralfil, 1 (with 11 duplicates, in 2025) for Tangible Fill, 0 for Purilens, 0 for Lacripure, and 51 for Nutrifill (2 from 2022, 1 from 2024 and 48 filed after the recall notice in 2025).

(For those not familiar with adverse event reporting: Reports can be filed by consumers and healthcare professionals, not just manufacturers. Here is a link to the Medwatch reporting form.)

4. "Aseptic manufacturing" is not for amateurs.

"Aseptic manufacturing" is the term for making products like our PF salines.

There is no room for error when it comes to sterility of this type of product.

This is specialist work, and it also takes a special kind of company culture.

The packaging requires special "blow-fill-seal" equipment and processes, whether for individual twist-off vials or "puncture-top" type bottles.

The validation processes are extremely involved and heavily dependent on ultra-meticulous record-keeping.

The written procedure requirements are endless.

When problems, issues or discrepancies show up, you don't just document them and move on. You search out the root cause and don't stop till you find it, correct it, document it, and figure out how to prevent it from recurring.

Training programs must be thorough and redundant.

Management, in addition to having all the training and experience to accomplish all these things, must also be able to foster and sustain a culture of excellence and deep commitment to quality throughout the company. 

Not only must the manufacturing facility itself have these capabilities, but companies hiring such manufacturers must have sufficient specialist knowledge to assess and monitor the manufacturer's track record.

 

5. "Aseptic manufacturing" is also not cheap... and we scleral lens users are a very small, high-stakes market.

While some ophthalmic companies make their own products at their own plants, most salines (and eye drops) are manufactured by third parties - that is, someone other than the company whose name and phone number are on the box. These third party manufacturers are commonly referred to as CMOs (Contract Manufacturing Organizations) or CDMOs (Contract Development and Manufacturing Organizations). 

Worldwide, there are not very many CMOs capable of top quality aseptic manufacturing. Of the ones that do exist, most are just too big to be hired by companies that want to either distribute small specialty products like scleral salines, or distribute a low cost product. The CMOs may demand impossibly large order sizes or unrealistically high prices or both. It is no coincidence that many of the recalled eye drops in recent years were generics. Drugstore brands seek out low cost manufacturers.

When the products in question are preserved eye drops, the stakes for failure are not quite as high because the preservative in the bottle (whose purpose is to neutralize contaminants that find their way into the bottle after you buy it and start using it) may compensate for some sterility failures during manufacturing. But when the products are preservative-free, everything is high stakes. 

 

6. So what does all this mean - for you, and me?

User risks vs product risks

I think we're all aware of user risks in some degree. We make our personal choices based on our knowledge, our risk tolerance, and our respect for our doctor's recommendations. For example, most people (thankfully) don't store lenses in preservative-free salines, but many people do re-use their saline vials for more than a day, keep their Purilens bottles open far longer than indicated on the packaging or recommended by their provider, etc.

But product risks from substandard manufacturing and packaging failures are not on most people's radars very much of the time. This only comes up if there is a recall that is blamed on manufacturing quality. Eventually we settle in with a different product and don't think about that anymore.

For me, volunteering on the Dry Eye Foundation's eye drop safety projects under the tutelage of DEF's medical advisor has been a yearslong and immensely valuable education process. It also keeps product safety consistently front of mind for me. Owning a retail business of course means I am responsible to not just choose well but monitor carefully. It also gives me a unique opportunity to hear constant community feedback over the years, which helps keeps me in touch with trends in user experiences - something I'm hugely grateful for.

The canary for our coal mine = manufacturers

The Nutrifill recall situation - contributing factors, injuries, aftermath - was very distressing. We don't want a repeat.

So how do I do my part? I monitor adverse event reports - but as I've said, those are only very rarely reported for this product type.

What else can I look to as an early warning system? 

The only answer I know is to start scrutinizing the CMOs themselves. FDA releases a lot of information on violations and failures identified in manufacturing facility inspections. If you know who the manufacturer is (not always easy to learn, since this tends to be closely held information) you can access quite a bit of summary information through the self-serve FDA dashboard. 

When an inspection has resulted in enough adverse findings to quality for the FDA's worst report-card outcome (OAI, or "Official Action Indicated", marked red on the timeline) there will also be a document called a Form 483 with detailed findings, which may or may not be available online. Redacted copies of these forms can be obtained through FOIA request. There are also companies that provide advanced analytical services relating to FDA compliance activity, which can be very helpful.

Non-specialists should probably not leap to conclusions about adverse findings in an isolated report. I have no stomach for causing panic by waving scary reports at people. However, if you are sufficiently conversant with form 483s and what the findings mean, trendlines of concern may seem fairly clear, such as years-long sustained inspection failures and repeated citations in critical areas such as procedures vital for sterility assurance, and procedures for handling of complaints. There may also be trends of non-routine ("for cause") FDA inspections, or - for non-US based manufacturers - import alerts, or recalls of unrelated products. The bottom line is the composite: Is this company performing, in general, at an acceptable level or do they have constant red flags? When issues arise, are they committed to engaging with those issues top to bottom, or not?

Acting on what we know 

I recently came across a saline manufacturer's name by accident while looking for records from a different company. I was curious, so I looked them up. When I reviewed the most readily available information, their FDA inspection history was surprising and deeply concerning to me. I felt compelled to do a much deeper dive.

After researching it as thoroughly as I knew how to and seeking advice, I also spoke with the company and manufacturer involved. To their credit, they could not have been more cooperative and courteous. However, the discussions did not yield information that mitigated my concerns. To me, scleral filling solution safety is not something I want to have any doubts about whatsoever. Ultimately, I removed two products made at that manufacturing facility from the shop. There was no information specifically implicating these individual products' safety, but like I said, the manufacturer's past performance is all I have, and I'm just not willing to take chances. 

This is what I felt I had to do based on the sum total of information available to me at this time. If the manufacturing facility gets an all-clear in writing from the FDA, or if the companies under whose names the products are distributed move the products to a different CMO in the future, I can always revisit the position.

Separately, Dry Eye Foundation has identified the manufacturers of each saline being marketed in the US for scleral filling and is currently conducting its own in-depth audit for the community. That will take time. My hope of course is that they will all be above reproach.

All for now,

Rebecca Petris
President, Dry Eye Shop