FDA Adverse Event Injury Summary report: N

HUBBLE SOFT HYDROPHILIC CONTACT LENS FOR DAILY WEAR

MDR report key: 18739798 · Received February 16, 2024

Report

Report Number
MW5151771
Event Type
Injury
Date Received
February 16, 2024
Date of Event
January 1, 2024
Report Date
February 9, 2024
Manufacturer
VISION PATH INC.
Product Code
LPL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

ON (B)(6) 2024 I EXPERIENCED A BILATERAL EYE INFECTION AFTER USING HUBBLE DAILY DISPOSABLE CONTACTS. I WAS TREATED WITH OFLOXACIN EYE DROPS AS PRESCRIBED FOR 7 DAYS. I DID NOT WEAR THE CONTACT LENSES DURING THE TREATMENT PERIOD. AFTER FINISHING THE ANTIBIOTIC REGIMEN AND HAVING THE INFECTION CLEAR, I USED A NEW SET OF HUBBLE CONTACTS AND WITHIN ONE DAY ON (B)(6) 2024, I EXPERIENCED A RETURN OF SYMPTOMS. I RECEIVED MOXIFLOXACIN EYE DROPS AND UTILIZED THEM AS PRESCRIBED FROM (B)(6) 2024. THE INFECTION CLEARED AND I ABSTAINED FROM WEARING CONTACT LENSES UNTIL (B)(6) 2024. I NOTICED SYMPTOMS AGAIN ON (B)(6) 2024 AFTER WORKING A NIGHT SHIFT, REMOVING MY CONTACTS AND GOING TO SLEEP. I AM CURRENTLY BEING TREATED WITH POLYMYXIN EYEDROPS. I WASH MY HANDS THOROUGHLY BEFORE AND AFTER REMOVING LENSES. BOTH PREVIOUS INFECTION TIMES I DISCARDED ALL EYE MAKEUP PRODUCTS AND PURCHASED NEW PRODUCTS. AT THIS TIME I DO NOT HAVE HEALTH INSURANCE DUE TO A CHANGE IN COVERAGE FROM TRANSITION FROM SCHOOL COVERAGE TO EMPLOYMENT PROVIDED COVERAGE SO ALL COSTS HAVE BEEN OUT OF POCKET. I HAVE NOW SPENT(B)(6) FOR THE FIRST WALK IN VISIT AND EYE DROP PRESCRIPTION. I SPENT (B)(6) FOR THE SECOND VISIT AND EYE DROP PRESCRIPTION. I HAVE NOT BEEN BILLED YET FOR THIS CURRENT VISIT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1603787 HUBBLE SOFT HYDROPHILIC CONTACT LENS FOR DAILY WEAR LENSES, SOFT CONTACT, DAILY WEAR LPL VISION PATH INC. 622189

Patients

Seq Age Sex Outcome Treatment
1 28 YR Female Other HUBBLE CONTACT LENSES. | MOXIFLOXACIN.| OFLOXACIN. | POLYMYXIN EYE DROPS.