7/12/24 statement from Rebecca Petris (DryEyeShop owner) about why Sereine ESDC is no longer sold here:

Sereine ESDC FAQ

What is Sereine ESDC?

Sereine Extra Strength Daily Cleaner is an alcohol-based contact lens cleaning solution. It has been popular with many scleral lens users, particularly since the unfortunate discontinuation of Lobob ESC in 2019 in the wake of extensive eye drop recalls by manufacturer Altaire in New York.

Sereine ESDC is made and distributed by a company in Colorado called Optikem International. 

We have stocked Sereine intermittently at Dry Eye Shop in recent years, depending upon availability. As many of you know, we typically only had it in stock for very short periods, with 2-3 month gaps in between.

Why is DryEyeShop no longer carrying Sereine?

We take safety very seriously here at the Dry Eye Shop, and we monitor FDA announcements, recalls and warnings regularly.

On July 9, 2024, the FDA published a Warning Letter that it had sent to Optikem on June 20th. This letter cites unacceptable manufacturing conditions and practices.

FDA Warning Letters are posted publicly on the FDA's website. Warning Letters to manufacturers are a form of communication used by the FDA to motivate companies who have serious unresolved violations of Current Good Manufacturing Practices (CGMP). When a warning letter is sent to a manufacturer, this is often done between six and eighteen months after an on-site inspection of the manufacturing facility and records, and typically only after a considerable history of correspondence, and when the company has been given ample opportunity to take corrective action. 

Did the FDA Warning Letter mention Sereine?

No. The FDA's Warning Letter did not mention Sereine, nor did we expect it to

The letter was directed to Optikem as a drug manufacturer and addressed issues with contract manufacturing of eye drops.

Eye drops are regulated as drugs. Contact lens solutions are regulated as medical devices. This means they fall under the jurisdiction of different parts of the FDA (CDRH for lens solutions, CDER for eye drops). So, Sereine products would likely not have been included in the same inspection process as any eye drops made by the same company, and therefore not addressed in the letter.

Before this letter, we were not aware that Optikem also manufactured eye drops.

Why has DryEyeShop discontinued Sereine anyway?

It was a no-brainer after reading the FDA Warning Letter.

As just one example, the company was told that the conditions at the facility "were not suitable to produce sterile drug products" and that they had failed to agree to FDA's requirement of stopping manufacturing until they corrected contamination hazards.

At the Dry Eye Shop, safety is very important to us. We monitor the FDA website daily for notices of product recalls, public warnings and safety notifications, and Warning Letters to manufacturers of products in the categories we sell. 

Have there been any problems reported with Sereine?

Not that we are aware of.

Has Sereine been recalled?

No.

I purchased Sereine recently. Should I use it?

We are not in a position to say whether Sereine is safe or unsafe since we have no official information from the FDA or from the manufacturer itself as our authority. 

However, after reading this appalling letter from the FDA to Optikem, I would never consider using it personally. (To me, it seems unlikely to cause harm, especially considering it's normally used before a lens disinfection cycle, but it's more the principle of the thing.)

I purchased Sereine at the Dry Eye Shop. Can I get a refund for opened or still sealed bottles?

Yes. Please contact us with your name, email/phone and/or order number and let us know how many you still have along with the lot number(s). We will be happy to refund them and you will not need to return them. 

What other product(s) can I use instead?

Ask your lens provider.

Here is some information to consider:

ALCOHOL-BASED CLEANERS: There are two additional alcohol-based daily cleaning solutions (similar to Sereine) on the market that we know of - Miraflow and LensFresh. We know nothing about their manufacturing or distribution. Because of ongoing adverse history in recent years with small ophthalmics manufacturers (from Altaire in 2019, to now Optikem now) I am no longer comfortable recommending ANY 'boutique' contact lens solutions unless/until we can somehow assure ourselves that their manufacturers are in compliance with CGMP.

MULTI-PURPOSE SOLUTIONS Boston Simplus Tangible Clean and Unique pH: These are NOT similar to Sereine, but for many (perhaps most) scleral lens 

I have stubborn lens deposits. What else can I use?

Boston One Step is an enzyme cleaner in liquid form that can be added to Boston Simplus overnight.

Progent is a very strong cleaning system that is somewhat complicated to use, but it is considered the most effective product on the market for removing lens buildup.

Make sure to check with your provider about what's is suitable for you.

If I have a problem with a contact lens solution, where should I report it?

To the manufacturer, and to the FDA's MedWatch.