Shortages, recalls, and counterfeit saline

Scleral wearers depend on a small number of preservative-free salines, and when one of them disappears it can feel like an emergency. People who wear sclerals describe three different problems that often get mixed up: a shortage (the product is fine, you just can’t get it), a recall (some of the product may be unsafe), and counterfeit or unregistered saline (a product you can’t be sure is sterile at all). Each needs a different response.

Brands are named as examples of products wearers use, not as endorsements.

Recalls: what happened with Nutrifill

Nutrifill, a preservative-free insertion saline that many wearers liked, has been recalled twice. In 2021 one lot was recalled because the solution might contain foreign material.^[2] On May 15, 2025, its maker, Contamac Solutions, recalled six lots (HFH, HGC, HGI, HGN, HKF, and HKK) because the solution may lack sterility. The FDA lists the cause as process control.^[1]

The maker’s notice says the recall followed customer complaints of red, irritated, burning, and painful eyes, with some infections and corneal ulcers, and that it had reports of twenty-three serious injuries the product may have contributed to.^[3] It also warns that people who have recently had eye surgery, have active eye disease, or have a condition affecting the integrity of the eye are at higher risk from a non-sterile product.^[3] That describes many scleral wearers.

Nutrifill is not among the products on its maker’s online store as of this writing. If you still have any at home, check the lot number. The maker’s notice told consumers to stop using affected lots and to return or discard them.^[3]

If your product is recalled

1. Stop using it. Check the lot number printed on the box or vial against the recall notice.
2. If your eyes have been red, painful, light-sensitive, or blurry, call your eye doctor today.
3. Keep the product and the box. If you’ve had a problem, your doctor may want to see it. The FDA also advises keeping your lens in its case for your eye care professional.^[10]
4. Report it. The FDA’s MedWatch program takes reports from patients and consumers.^[8] You can tell the maker too.
5. Ask your fitter what to switch to. Then follow the return or refund steps in the notice.

You can search the FDA’s medical device recall database by product name.^[4] The FDA also keeps a page of eye drop alerts and recalls, which has included a lot of preservative-free single-use lubricant vials recalled for fungal contamination.^[6] Wearers say a sterile product suddenly going out of stock is sometimes the first sign of a quality problem, so it’s worth checking.

Shortages: when your saline is just gone

Wearers have lived through long backorders of popular buffered fills, thick lubricant drops, and favorite cleaners. Some products were discontinued for good. What helps:

• Call your fitter before you switch. They may have samples, know what’s in stock locally, or prefer a specific substitute for your eyes.
• Know your type. Fills are either buffered or unbuffered. PuriLens’s maker, for example, lists LacriPure, Addipak, and respiratory 0.9% saline as unbuffered.^[11] If your eyes need a buffered fill, an unbuffered one may not feel the same, and the reverse is also true.
• Respiratory saline is off-label. Unit-dose nebulizer saline is a common stopgap, sometimes by prescription. Its FDA clearance is for airway use, and it is intended for inhalation only.^[12] Use it only if your fitter says it’s okay.
• Keep a cushion. Many long-time wearers keep several weeks to a few months of supplies, rotated oldest first, and order early before holidays and bad weather.

Counterfeit and unregistered saline

During shortages, wearers have reported unfamiliar “scleral saline” brands appearing on large online marketplaces, lookalike vials copying a known brand’s colors, listings showing unsafe uses like soaking lenses overnight in saline, and screw-cap bottles that arrived leaking with the seal still intact. People who wear sclerals have also flagged expired or damaged stock sold by third-party resellers.

This is not only a saline problem. The FDA has warned about “copycat” eye drops sold online that are easily mistaken for a known brand, and found contamination in samples it bought.^[7] It notes that eye products bypass some of the body’s natural defenses, and that facilities making eye drops for the US must be registered with the FDA.^[6]

How to check what you’re buying

• Buy from a known source: the maker’s own site, your fitter’s office, a pharmacy, or a retailer you trust.
• Read the label. It should say sterile and preservative-free, name the maker, and carry a lot number and expiry date.
• Check the packaging. Don’t use a product whose single-dose container is leaking or damaged, or whose solution is cloudy or discolored. That’s the instruction on Cleadew SLi’s label, and it’s a good test for any fill.^[13]
• Look the maker up. You can search the FDA’s device registration and listing database by company or product name.^[5] Not finding it is a reason to ask your fitter before using it.
• Check dates. Don’t use any solution past its expiration or discard date.^[9]
• When in doubt, don’t. A cheap or available product is not a bargain if you can’t be sure it’s sterile, even for rinsing.

Mistakes that come up again and again

Shortages push people toward shortcuts. These are the ones wearers most often warn each other about:

• Stretching vials or bottles. Recapping a single-use vial or using an opened bottle past its window to save supply. An opened preservative-free product isn’t sterile anymore.
• Filling with whatever is on the shelf. Large drugstore salines and multipurpose solutions usually contain preservatives and don’t belong in the bowl.
• Making your own. The FDA warns never to use homemade saline or non-sterile water of any kind.^[9]
• Decanting into travel bottles. The FDA warns this can affect sterility and lead to using the wrong solution.^[9]
• Keeping a recalled lot “for emergencies.” It isn’t safer later.
• Buying recalled product from resale sites. Recalled lots have turned up for sale secondhand.
• Changing your whole system at once. Change one product at a time, with your fitter’s approval, so you can tell what’s causing a problem. Cleadew SLi’s instructions put it plainly: don’t change your lens care system without consulting your eye care professional.^[13]

For what to fill with in the first place, see what to fill your scleral lens with. For a kit to carry, see your emergency kit.