I purchased a bottle of Systane Original Long Lasting Dry Eye Eyedrops. Unfortunately, after using the drops for a few months, I noticed a long splinter like object in the neck of the eyedrop bottle. Alcon Labs (maker of Systane eydrops) was notified and they asked that the bottle be sent back to them for analysis.
Their lab determined that the object was a foreign substance and “biological” in nature. No explanation, no details, nothing. That was it. All they said was “Alcon has completed its investigation into Mr. Harris’ complaint, and Alcon’s investigation is complete. The lab identified that it was a foreign substance, biological in nature, and the object did not exist at the time of the product’s sale.” Case closed.
Despite nearly a year of correspondence with Alcon and eventually their attorney, everyone has declined to answer several fundamental questions:
· What specifically was the biological, foreign substance?
· How did the laboratory determine that it was biological?
· How did the foreign substance enter the bottle?
· Could exposure to the substance have any potential long-term effects on my eyesight?
Their statement raised several additional questions. How can Alcon conclude with certainty that the foreign object was not present at the time the product was manufactured? What evidence supports that conclusion? Was the bottle traced through each stage of manufacturing, packaging, shipping, and retail distribution before that determination was made?
The eye drops were purchased from a locked display case at Walmart. I did not tamper with the bottle, and I have no reason to believe that Walmart employees or any customers did either. The bottle was sealed when I purchased it.
Nevertheless, Alcon appears to have ruled out any manufacturing responsibility without explaining the basis for that conclusion.
If Alcon’s laboratory confirmed that a biological foreign substance was present inside one of its products, why has the company declined to identify what the substance was, explain how it entered the bottle, or address whether it presented any potential health risk?
These are reasonable questions that remain unanswered.
I am also concerned that Alcon is withholding information that could be important to all consumers. If there is no reason to withhold the laboratory findings, I question why they have not been released or why my straightforward questions have not been answered.
My concern is heightened because Alcon has previously been the subject of FDA observations involving manufacturing and quality-control issues, including water-system validation, clean-room procedures, and product recalls involving sterility concerns. I believe in 2024, 2025 and early 2026 Systane had to recall their eyedrops due to fungal contamination. This underscores the importance of transparency when a consumer reports a biological foreign substance inside a medical product.
I requested that Alcon return the contaminated bottle to me so that I could have an independent lab do the research that Alcon refused to do.
It took Alcon 2 months to return the bottle after receiving my request. This unexplained delay, when viewed together with the company's continued refusal to provide meaningful answers regarding the laboratory's findings, raises serious concerns about Alcon's commitment to transparency and good-faith communication. Why was my property withheld for more than seven weeks, and who made that decision?
I have attempted to resolve this matter directly with Alcon in a cooperative and professional manner. Unfortunately, instead of transparency, I have encountered delays, incomplete answers, and the continued withholding of evidence that is essential to obtaining an independent evaluation.
Complaints have already been filed with the Better Business Bureau (cannot enforce any legal action) and the FDA (could take 6 months for a response).
My Ophthalmologist noticed a change in my vision since my last check up and stated it would have been beneficial if Alcon had provided them with detailed information regarding the “foreign, biological” object so that they could make an appropriate diagnosis. Alcon has refused all of my requests.
What is Alcon hiding? Why have they refused to release the detailed lab’s findings? Why aren’t they concerned how the object got into one of their bottles. Perhaps having more scrutiny, bad press and another potential recall, so close to the last one, would be an embarrassment for their company.
If Alcon is not guilty of a cover up, why continue to act as if they are?
It should be noted that I sent letters to Alcon’s CEO, COO, CFO, SVP General Council SVP Global Manufacturing, SVP Human Resources, SVP Marketing/Sales and Customer Service Dept, but no one cares.
Recommendation: Think twice before purchasing any Alcon/Systane eyedrop products