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