4Q23 Regener-Eyes adverse event reports

 
 

Two additional Regener-Eyes adverse event reports appeared in the FDA Adverse Event Reporting System (FAERS) Public Dashboard as of 12/31/23.

This makes five total adverse events for Regener-Eyes, none of which were reported by the company itself.

FAERS Primary ID: 230401611

  • In this adverse event report, Regenereyes Pro was reported as the primary suspect for the adverse event.

  • “Dry eye” was the indication for taking Regenereyes Pro.

  • Event date = September 27, 2023

  • Report date = October 6, 2023

  • Report submitted by a consumer.

  • Patient was 58yo female.

  • Therapy lasted 3 days, from September 25-27, 2023.

  • Consumer reported:

    • Product formulation issue

    • Eyelids pruritus

    • Eye irritation

    • Eye pruritus

    • Eczema eyelids

    • Ocular hyperaemia

FAERS Primary ID: 231045031

  • In this adverse event report, REGENER-EYES LITE was reported as the primary suspect for the adverse event.

  • “Dry eye” was the indication for taking Regenereyes Lite.

  • Event date not listed.

  • Report date = October 24th, 2023

  • Report submitted by a consumer.

  • Patient was 59yo female.

  • Therapy lasted 2 weeks, dates not listed.

  • Consumer reported:

    • Vision blurred

    • Eye pain

    • Headache

    • Hypoaesthesia eye

    • Lip disorder

    • Ocular discomfort

    • Dizziness

Previous adverse event reports

2023

22788895

Suspect product: Regener-Eyes Lite

Indication: Ocular Hyperaemia

Reactions: Throat Irritation, Pain, Brain Fog

FDA received report 8/3/23

2022

21265920

Suspect product: Regenereyes Lite

Indication: Dry Eye, Eye Inflammation

Reactions: Eye Discharge, Instillation Site Irritation, Condition Aggravated, Eye Inflammation, Paradoxical Drug Reaction, Product Prescribing Issue, Vision Blurred, Dry Eye, Eye Irritation, Product Use In Unapproved Indication, Product Sterility Issue, Product Packaging Issue, Product Use Complaint, Product Container Issue

FDA received report 8/28/22

Serious: Yes

21095089

Suspect products: Regenereyes Lite, Regenereyes Pro

Indication: Dry Eye, Product Used For Unknown Indication

Reactions: Vision Blurred, Product Packaging Issue, Adverse Drug Reaction, Product Complaint

FDA received report 7/16/22

Search the FAERS database here

Report adverse events here

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