PERFLUOROHEXYLOCTANE: 870 Adverse Event Reports & Safety Profile
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Drug Class: Semifluorinated Alkane [EPC] · Route: OPHTHALMIC · Manufacturer: Bausch & Lomb Incorporated · FDA Application: 216675 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
Patent Expires: Sep 29, 2036 · First Report: 2019 · Latest Report: 20250914
What Are the Most Common PERFLUOROHEXYLOCTANE Side Effects?
All PERFLUOROHEXYLOCTANE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Inappropriate schedule of product administration | 135 | 15.5% | 8 | 8 |
| Vision blurred | 132 | 15.2% | 0 | 2 |
| Product delivery mechanism issue | 122 | 14.0% | 0 | 2 |
| Eye irritation | 110 | 12.6% | 0 | 1 |
| Product use issue | 110 | 12.6% | 2 | 5 |
| Product complaint | 87 | 10.0% | 0 | 1 |
| Product use complaint | 86 | 9.9% | 0 | 0 |
| Circumstance or information capable of leading to medication error | 85 | 9.8% | 0 | 1 |
| Ocular hyperaemia | 82 | 9.4% | 0 | 1 |
| Accidental exposure to product | 75 | 8.6% | 0 | 0 |
| Exposure via skin contact | 75 | 8.6% | 0 | 0 |
| Intentional product use issue | 66 | 7.6% | 0 | 1 |
| Drug ineffective | 65 | 7.5% | 0 | 1 |
| Eye pain | 60 | 6.9% | 0 | 3 |
| Visual impairment | 51 | 5.9% | 0 | 0 |
| Dry eye | 50 | 5.8% | 0 | 3 |
| Wrong technique in product usage process | 48 | 5.5% | 0 | 3 |
| Product container issue | 45 | 5.2% | 0 | 1 |
| Product knowledge deficit | 41 | 4.7% | 1 | 0 |
| Burning sensation | 40 | 4.6% | 0 | 1 |
Who Reports PERFLUOROHEXYLOCTANE Side Effects? Age & Gender Data
Gender: 82.8% female, 17.2% male. Average age: 71.2 years. Most reports from: US. View detailed demographics →
Is PERFLUOROHEXYLOCTANE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2019 | 2 | 0 | 0 |
| 2022 | 1 | 0 | 0 |
| 2023 | 40 | 0 | 2 |
| 2024 | 136 | 1 | 7 |
| 2025 | 229 | 15 | 31 |
What Is PERFLUOROHEXYLOCTANE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 465 |
| Dry eye | 355 |
| Product use in unapproved indication | 15 |
| Meibomian gland dysfunction | 7 |
PERFLUOROHEXYLOCTANE vs Alternatives: Which Is Safer?
Official FDA Label for PERFLUOROHEXYLOCTANE
Official prescribing information from the FDA-approved drug label.
Drug Description
MIEBO ® (perfluorohexyloctane ophthalmic solution) is a sterile, clear and colorless liquid containing 100% perfluorohexyloctane, for topical ophthalmic use. The active ingredient is 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorotetradecane and is a semifluorinated alkane. It has a molecular formula of C 14 H 17 F 13 and a molecular weight of 432.26 g/mol. The chemical structure is: Perfluorohexyloctane is practically immiscible with water. It is miscible with ethanol and most organic solvents. Each multiple-dose bottle contains 3 mL of perfluorohexyloctane, 1.338 g/mL as a clear and colorless liquid. A structure of a chemical formula AI-generated content may be incorrect.
FDA Approved Uses (Indications)
AND USAGE MIEBO ® (perfluorohexyloctane ophthalmic solution) is indicated for the treatment of the signs and symptoms of dry eye disease (DED). MIEBO (perfluorohexyloctane ophthalmic solution) is a semifluorinated alkane indicated for treatment of the signs and symptoms of dry eye disease. ( 1 )
Dosage & Administration
AND ADMINISTRATION Instill one drop of MIEBO four times daily into each eye. ( 2.1 )
2.1 Recommended Dosage Instill one drop of MIEBO four times daily into affected eye(s). Contact lenses should be removed prior to and for at least 30 minutes after the administration of MIEBO.
2.2 Administration Instructions Step 1. Remove the cap from eye drop bottle.
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2. Holding the bottle upright, gently squeeze the bottle.
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3. While squeezing, turn the bottle upside down and release the pressure (drawing air into the bottle).
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4. Keeping the bottle upside down, place the bottle above your eye and squeeze it again to release a drop into your eye. Repeat steps 1 - 4 for the second affected eye.
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2.
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3.
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Contraindications
Hypersensitivity. ( 4.1 )
4.1 Hypersensitivity MIEBO is contraindicated in patients with a history of hypersensitivity reaction to perfluorohexyloctane <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.1 )]</span> .
Known Adverse Reactions
REACTIONS Most common ocular adverse reaction was blurred vision. Blurred vision was reported in less than 4% of individuals. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In patients with DED, 614 patients received at least one dose of MIEBO in two randomized controlled clinical trials across 68 sites in the United States. The most common ocular adverse reaction was blurred vision. Blurred vision and conjunctival redness were reported in 1-3% of individuals. In four premarketing studies (three open-label [n=127], one randomized [n=24 treated with at least one dose of perfluorohexyloctane]) the most common adverse reaction was hypersensitivity.
Warnings
AND PRECAUTIONS