May 31, 2025

ALERT #1: Nutrifill

We recommend not using Nutrifill, regardless of lot number.

On 3/3/25, we learned that Contamac Solutions had halted distribution of Nutrifill. 

On 5/15/25, we received a notice from Contamac Solutions that they were issuing a voluntary recall of six lots of Nutrifill (HFH, HGC, HGI, HGN, HKF, HKK). They had received seven complaints containing reports of 23 serious injuries that the recalled product may have contributed to, ranging from “redness, burning and irritation to infections that sometimes resulted in the development of corneal ulcers”. 

The notice stated that 605,465 saline ampoules “may not be sterile” Two “significant quality failures” had been identified at their contract manufacturer as the likely cause. 

Samples from four lots (HFH, HGI, HGN and HKK) were re-tested and found to be non-sterile.

We do not know whether the two recalled lots HGC and HKF have been re-tested. 

We do not know whether any non-recalled lots still within expiry have been re-tested, i.e. those which were manufactured or distributed either before or after the recalled lots.

In other words, we know lots HFH, HGI, HGN and HKK are NOT okay, but we don’t know which others, if any, ARE okay, and we know there are unresolved sterility issues.

As a result, we’re cautioning customers against using Nutrifill, regardless of whether the lot number matches a lot number on the 5/15/25 recall list.

ALERT #2: Leaky vials (any brand)

New saline vials shouldn't leak. This is a safety red flag, not just an inconvenience.

• DON'T use leaky vials.
• DO report leaky vials, immediately, to the manufacturer or distributor and to the retailer. Make sure you communicate clearly about whether there is any visible reason for the product to leak, such as the outer box being punctured or crushed.
• DO expect the company to follow up.

Vials that leak are an indication of potential non-sterility, which is serious. If there is no evidence of external damage, this may suggest faulty manufacturing.

How do I know I have a leaky vial? 

It's not always obvious!

• Is any part of the box damp from the inside?
• Are there any moisture stains on the box?
• Squeeze a vial gently - if there’s a hole (which may be on a seam or in a corner) you’ll see a tiny stream of saline. We have come across instances of just a handful of vials in a box failing the squeeze test.
• Check saline level. In a strip of vials, a less-filled vial will be noticeable. Very slight differences do not necessarily indicate a problem, but any significant differences should prompt a check for leaks.

It is not normal for new PF saline vials to leak!

Here at the Dry Eye Shop, we have more than 10 years' experience with receiving and shipping preservative-free salines. We have handled every brand ever since they were first marketed for scleral lens filling, and additional brands commonly used off-label in the past.

In our experience, properly manufactured saline vials should not and do not leak except under extreme conditions. For example, over the years we have received shipments of multiple brands of saline where cases of saline were apparently punctured by a forklift or crushed by the freight company. Even in those cases, leakage rarely results. Merchandise whose retail packaging is damaged is typically returned to our vendor or discarded. If we receive saline with any evidence of leaking without a clear explanation, we draw the manufacturer's attention to it specifically.

Saline vials must withstand the cumulative effect of transportation as they travel from the manufacturer to the distributor to retailers and finally to your home. If sterile packaging is failing under ordinary retail transportation conditions, it's a red flag.

ALERT #3: "See something, say something"

See what?

Anything unusual about the condition or contents of new vials is a potential cause of concern, especially signs of particulate matter. The 2021 Nutrifill recall referenced black particulate matter in some vials. Unexplained leakage or holes indicate potential non-sterility. A recent FDA Warning Letter to a European manufacturer referenced customer complaints of "mold, black specs and discoloration" on or inside vials. Incidentally, that company was called out for blaming customers for handling the product incorrectly and failing to investigate the complaints properly. The facility inspection revealed that there had been mold in production areas for up to 3 years.

Say something to whom?

1. Your doctor.
2. The manufacturer. 
3. The seller (whether online or local).
4. The FDA. Use this Medwatch form.

More information about why this matters

A reminder about what "preservative-free" is, and isn't.

For filling scleral lenses, preservative-free solutions are essential.

But it's easy to forget that preservatives have a purpose in solutions and eye drops: stopping contamination. Contamination of eye drops or solutions can cause serious harm.

For unpreserved products, preventing contamination BEFORE you start using the product means the manufacturing company must be true pros who have a long-term commitment to following all established safeguards. Preventing contamination AFTER you start using the product means following the instructions, i.e. please don't leave those "single-use" vials open day after day, even if there's leftover saline going to waste. (Hint: use it for rinsing.)

A little background on saline manufacturing and risk of contamination

Preservative-free saline solutions for scleral lenses, much like artificial tears in single-use vials, undergo a special manufacturing process using a technology called “blow-fill-seal”. This is done under very strict sterile ophthalmic manufacturing conditions that include extensive testing protocols to ensure every batch of packaged saline is sterile. 

Solution sterility is essential for scleral lens patient safety because scleral lenses hold saline against our eyes for long periods, meaning a contaminated solution in a scleral lens puts us at higher risk of infection through extended exposure. 

Packaging integrity is essential for scleral lens patient safety because if bacteria or mold have any possible way to get into a container during manufacturing, storage or shipment, there is no preservative in the solution to prevent them from reproducing, which also increases our risk.

Bacterial or fungal contamination can cause infections that lead to serious harm, including vision loss. In 2023, CDC reported that 4 people died and 18 people lost vision or lost an eye due to pseudomonas infections from eye drops contaminated during manufacture. Those were just eye drops, without the added risk factor of being held against the eye by a scleral. In addition, one case of an acanthamoeba keratitis infection leading to the need for a corneal transplant was reported to the FDA a few years ago with potential attribution to a recalled lot of a preservative-free scleral filling solution.

This is why quality standards for sterile manufacturing facilities are so stringent. The risks are real. Just as scleral lenses are not commodities, neither are the salines that we fill them with.

Times have changed and so have manufacturers

In the distant past, most preservative-free solutions and eye drops were made by a handful of trusted very large manufacturers. This has gradually changed. The big ones have continued, but due to steadily rising demand, many smaller companies have entered the business.

Newer, smaller manufacturers don't always make the investment required to follow the sets of manufacturing rules (known as CGMP) for sterile manufacturing. This is clear from the abysmal FDA inspection records of many of these smaller manufacturers, such as those making generic eye drops, and a long succession of FDA Warning Letters in recent years. When we look at a facility inspection record on the FDA's website and see things like "Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established" (yes, this is a real example), it's deeply concerning. 

In case you're wondering, this is not an overseas drug manufacturing problem exclusively or any one country or region. There have been an increasing number of recalls from US-based manufacturers for sterility reasons, and very concerning FDA Warning Letters sent to US and European manufacturers as well.

What all this means for us here at the Dry Eye Shop

Thanks to several years of working on Dry Eye Foundation's Eye Drop Safety program*, I now know that in today's world, preservatives have unfortunately become the last line of defense against contamination during manufacturing, in addition to doing their real job, which is to prevent contamination during consumer use.

So, as a retailer, our two choices are:

1. buy/sell only preserved solutions and drops, or
2. buy/sell preservative-free solutions and drops only from trusted manufacturers,

For our dry eye and scleral lens customer base, #1 is obviously not an option.

So who's a trusted manufacturer? And for products made by contract manufacturers that the brand company is not anxious to reveal, how do we even find out where a product is made?

These are the sorts of things we're grappling with. I don't have all the answers. All I can say is the obvious: that this is very important to us, we're working really hard on it, and we'll keep at it.

Sincerely

Rebecca Petris

owner

 

*To learn more about eye drop safety issues, please see DEF's 2023 Annual Report, pages 9-15.