Keratopigmentation: Risks, Side Effects and Complications

Before changing the color of your eyes, one question comes before all others: what are the risks of keratopigmentation? It deserves a straight answer. Like any surgery on the cornea, keratopigmentation is not a trivial procedure. It has common but short-lived side effects, rarer but serious complications, and contraindications that must be respected. Yoni Gozlan, M.D., an ophthalmic surgeon in Paris 16, reviews what medical sources say, including the French National Academy of Medicine, and how these risks are managed at Centre Laser Victor Hugo. Yoni Gozlan, M.D. has operated on more than 1,000 patients and has over 10 years of experience.

This sourced review covers the side effects and complications described in the medical literature. For safety specific to the FLAAK technique, read is FLAAK keratopigmentation dangerous? For eligibility criteria in detail, see contraindications to FLAAK keratopigmentation.

Key points at a glance

• In the days after surgery, pain, dryness, glare, redness and tingling are common. They are usually temporary.
• More serious complications are possible, as after any corneal surgery: infection, inflammation, reaction to the pigment, loss of endothelial cells.
• The cosmetic result has limits: a color that can look too uniform, possible fading over time, a touch-up sometimes needed.
• Long-term data on purely cosmetic keratopigmentation are still limited.
• Careful patient selection and a thorough pre-operative assessment are essential.

What the French National Academy of Medicine says

On June 18, 2025, the French National Academy of Medicine (Académie nationale de médecine) published a statement titled "La kérato-pigmentation des yeux : un essor qui n'est pas sans risques" (roughly, "Eye keratopigmentation: a growing practice that is not without risks"). We believe every patient should read it. Here are its main points, faithfully summarized.

The technique. The Academy describes a procedure performed in an operating room under strict asepsis, without a hospital stay, after anesthetic eye drops. A femtosecond laser creates a ring-shaped tunnel within the thickness of the cornea, into which a sterile, biocompatible pigment is injected. No stitches are needed.

Cosmetic limits. The resulting color can be too uniform, may fade over time, and can look unnatural because of its even appearance and because the original shade remains visible around the edge of the cornea.

The risks. The Academy states that strict asepsis and following post-operative advice help prevent infectious keratitis. It mentions:

• a risk of dry eye and glare, as after any corneal surgery;
• a loss of endothelial cells, described in the literature, which may contribute to the cornea becoming less clear with age;
• the fixed pupil diameter set by the pigmented ring, which can hinder the examination and treatment of lesions at the edge of the retina during later eye exams;
• metallic compounds in some pigments, which may pose a risk during an MRI scan.

The recommendations. The Academy stresses the importance of an information document, drawn up by the relevant medical societies, given to patients beforehand; it warns about the risks of treatment abroad at attractive prices without any assurance of the practitioners' skills; and it says the possible short-, medium- and long-term consequences should not be underestimated, given the limited follow-up so far.

We share these standards. The statement does not say the procedure should be banned. It says it should be explained, supervised and reserved for patients who are properly informed and selected. That is exactly the framework we apply, as described below.

Common side effects: what patients experience

A published survey of patients' experience after cosmetic FLAAK keratopigmentation was carried out in Paris among 42 patients who had returned for a color touch-up (BMC Ophthalmology, 2023). It gives a concrete picture of recovery:

• Pain: 81% of patients;
• Dry eyes: 76%;
• Tingling: 71%;
• Red eyes: 67%;
• Glare: 56%.

No patient reported visual halos. All of these symptoms were temporary. Pain, tingling, glare and redness had cleared within 48 hours in about half of the patients; when they lasted longer, their median duration was 7 days. Average satisfaction with the cosmetic result was 8.1 out of 10.

These figures should be read with caution: the sample is small, the symptoms were self-reported, and one of the authors declares an interest in the company that makes the pigments. Above all, they show that the first few days call for a little patience. Our article on recovery after FLAAK keratopigmentation covers this period and what helps.

Rarer but serious complications

In January 2024, the American Academy of Ophthalmology (AAO) issued a warning about eye color-changing surgery. For keratopigmentation, it lists the following possible risks:

• damage to the cornea that can lead to cloudiness, warpage, fluid leakage and vision loss;
• light sensitivity;
• reaction to the dye, causing inflammation, uveitis or blood vessel growth into the cornea;
• bacterial or fungal infection, which can leave corneal scarring and vision loss;
• uneven distribution of the dye;
• leakage of the dye into the eye, and color fading if it moves.

The AAO reminds patients that no surgery is free of risk and asks anyone considering a purely cosmetic procedure to weigh those risks against the expected benefit. We fully endorse that message: an informed decision means knowing the unfavorable scenarios too, even rare ones.

On the research side, a 2025 literature review (Indian Journal of Ophthalmology) concludes that femtosecond-assisted keratopigmentation appears safe and effective, but that long-term studies are needed to better understand the risks of purely cosmetic use. Both statements belong together: the available data are encouraging, and long-term evidence is still being built.

Cosmetic limits and touch-ups

One risk that gets less attention is disappointment. A natural iris is full of nuances, texture and reflections. Pigment placed in the cornea gives a more even look, and the original shade stays visible as a thin rim at the edge. Some people love this look; others find it too uniform. Over time the color may also soften, and a touch-up is sometimes offered to adjust intensity or evenness.

Finally, keratopigmentation is considered permanent: a touch-up is possible, but removing the pigment completely is technically complex. Looking at real results, discussing the colors that suit your complexion and giving yourself time to think are all part of prevention.

Contraindications

Some situations rule the procedure out or mean it must be postponed. They are systematically checked during the assessment:

• a cornea that is too thin, keratoconus or suspected keratoconus;
• corneal disease, an active eye infection or inflammation, a history of ocular herpes;
• severe, uncontrolled dry eye;
• uncontrolled glaucoma;
• certain general conditions, especially autoimmune diseases, which require case-by-case assessment;
• age under 18;
• pregnancy or breastfeeding: as a precaution, the procedure is not performed during these periods.

Previous refractive surgery (LASIK, PRK) is not necessarily a contraindication, but it requires a precise analysis of the remaining corneal thickness. The full list is in our article on contraindications to FLAAK keratopigmentation.

Our approach: select and examine

No surgery can be made risk-free, but a rigorous framework helps reduce the risks. This is the one followed by Yoni Gozlan, M.D.

1. Honest patient selection

Not everyone is a good candidate, and saying no is part of a surgeon's job. The consultation is first of all about understanding your plans and expectations, checking that they are realistic, and explaining the benefits, limits and risks of the procedure. If an examination reveals a contraindication, the procedure does not go ahead.

2. A thorough pre-operative assessment

Before any decision, a complete eye examination is carried out: visual acuity, corneal topography and pachymetry (corneal thickness), endothelial cell count, slit-lamp examination, tear film assessment, eye pressure measurement and a retinal examination. The endothelial cell count and the retinal examination directly address two of the points raised by the Academy. To learn more, read our article on the pre-operative consultation.

3. Surgery in an operating room, in Paris

The procedure is performed in the operating room of Centre Laser Victor Hugo, under the aseptic conditions of eye surgery.

4. After the procedure

Eye drops adapted to healing are prescribed. After that, a yearly visit to an ophthalmologist is recommended, as after any eye surgery. Remember to tell any ophthalmologist who examines you about your keratopigmentation, and to tell the radiologist before an MRI.

When should you seek care without delay?

After surgery, some signs should prompt you to contact your surgeon quickly: pain that gets worse instead of better, reduced vision, intense redness, discharge, or increasing sensitivity to light. Prompt care is the best way to limit the consequences of a complication.

FLAAK keratopigmentation costs €5,500 for both eyes; what is included is detailed in our article on the cost of FLAAK keratopigmentation.

Sources

• French National Academy of Medicine (Académie nationale de médecine), "La kérato-pigmentation des yeux : un essor qui n'est pas sans risques", press release, June 18, 2025.
• American Academy of Ophthalmology, "American Academy of Ophthalmology Issues Warning on the Dangers of Eye Color-Changing Procedures", January 29, 2024.
• Alafaleq M, van Haselen R, Ferrari F. The safety and effectiveness of a novel annular keratopigmentation technique; a cross-sectional survey of patients. BMC Ophthalmol. 2023;23:292.
• Balparda K, Agudelo-Cardona M, Ferrari F et al. Keratopigmentation in the modern era: A review of current techniques, results, and safety. Indian J Ophthalmol. 2025;73(8):1108.

Further Reading

• How to change your eye color: every option in 2026: lenses, implants, laser and keratopigmentation, compared honestly.
• Contraindications to FLAAK keratopigmentation: eligibility criteria and situations where the procedure is not recommended.
• Recovery after FLAAK keratopigmentation: post-operative care, day by day.

This article is for general information only. It does not replace a medical consultation: only an eye examination can assess the benefits and risks in your situation.