FDA approvals and recalls

Eye health: FDA Approvals, Recalls, 510(k) Clearances and Side Effect Reports

What the US Food and Drug Administration has cleared, approved and recalled on this topic, and the side effects people report.

Each number has its full source under its own list below.

New drug approvals

3 new medicines approved (since 1 Jan 2023). Medicines with a new active ingredient that the FDA approved, whose label lists a use on this topic.

At the source

  • Lumvoa (veligrotug)

    Approved for: LUMVOA is indicated for the treatment of thyroid eye disease regardless of thyroid eye disease activity or duration. LUMVOA is an insulin-like growth factor-1 receptor inhibitor i…

    BLA761530

  • Tryptyr (acoltremon)

    Approved for: TRYPTYR is indicated for the treatment of the signs and symptoms of dry eye disease. TRYPTYR is a TRPM8 thermoreceptor agonist indicated for the treatment of the signs and symptom…

    NDA217370

  • Miebo (perfluorohexyloctane)

    Approved for: MIEBO ® (perfluorohexyloctane ophthalmic solution) is indicated for the treatment of the signs and symptoms of dry eye disease (DED). MIEBO (perfluorohexyloctane ophthalmic soluti…

    NDA216675

Source: openFDA, Novel drug approvals (new molecular entities and new biologics), since 1 Jan 2023. Retrieved 12 Nov 2026.

Drug recalls

18 recalls (since 1 Jan 2023). Recalls of medicines for this topic, newest first.

At the source

Source: openFDA, Drug recall enforcement reports, since 1 Jan 2023. Retrieved 12 Nov 2026.

Device recalls

197 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.

At the source

  • Eye Tray

    Reason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

    Z-0178-2027

  • Tomography, Optical Coherence

    Reason: Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or…

    Z-3215-2026

  • Eye Tray

    Reason: Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection…

    Z-3210-2026

  • Kit, Surgical Instrument, Disposable

    Reason: Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of po…

    Z-3069-2026

  • Eye Tray

    Reason: Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of po…

    Z-3078-2026

  • Eye Tray

    Reason: Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

    Z-2949-2026

  • Eye Tray

    Reason: The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to th…

    Z-3061-2026

  • Eye Tray

    Reason: The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identi…

    Z-2547-2026

  • Eye Tray

    Reason: Incorrect concentration of Betadine solution contained within certain AVID convenience kits.

    Z-2763-2026

  • Eye Tray

    Reason: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances…

    Z-2507-2026

Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.

510(k) clearances

17 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.

At the source

Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.

Side effects people report

14,654 side effect reports (reports received since 1 Jan 2023). The reactions named most often in reports about medicines used for this topic.

At the source
  1. 1Eye irritation2,589 reports
  2. 2Eye pain1,714 reports
  3. 3Vision blurred1,323 reports
  4. 4Dry eye1,137 reports
  5. 5Ocular hyperaemia940 reports
  6. 6Cataract713 reports
  7. 7Headache580 reports
  8. 8Lacrimation increased566 reports
  9. 9Visual impairment561 reports
  10. 10Eye pruritus488 reports

Anyone can send a report. A report does not prove that the medicine caused the reaction, and the counts do not show how often it happens.

Source: openFDA, FDA Adverse Event Reporting System (FAERS), reports by reaction, reports received since 1 Jan 2023. Retrieved 12 Nov 2026.

Benchmarks on eye health

Countries side by side on public measures for this topic.

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Market reports on eye health

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Cataract and Avoidable Blindness Public Health Report

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Childhood Vision and Refractive Error Public Health Report

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Diabetic Retinopathy Public Health Report

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