FDA Adverse Event Injury Summary report: N

SOLOTICA HIDROCOR TORIC FOR ASTIGMATISM

MDR report key: 19876986 · Received July 30, 2024

Report

Report Number
MW5157853
Event Type
Injury
Date Received
July 30, 2024
Date of Event
December 26, 2023
Report Date
July 26, 2024
Manufacturer
SOLOTICA INDUSTRIA E COMERCIO LTDA
Product Code
LPL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I ORDERED SOLOTICA LENS FROM THEIR WEBSITE, WHICH ADVERTISED THEIR LENSES AS TOROS LENS FDA APPROVED GOOD FOR ONE YEAR, HOWEVER INSURANCE WOULDN'T COVER THEM, AND SO I PAID (B)(6) FOR ONE PAIR OF AS ADVERTISED "TORIC LENS" FOR MY ASTIGMATISM, BECAUSE THEY CLAIMED THEY WERE FDA APPROVED FOR TORIC SALES. I WAITED 12 WEEKS FOR ME TO GET THESE LENS, AND WHEN I GOT THEM THEY WERE NOT TORIC. THE LENSES WERE ALWAYS MOVING, FOGGING UP, AND MAKING MY VISION EVEN MORE BLURRY. COME TO FIND OUT THEY ARE NOT TORIC AT ALL, EVEN THE BOTTLE SAYS THEY ARE REGULAR COLOR CONTACTS WITH MY TORIC. TORIC LENSES ARE SUPPOSED TO BE WEIGHTED THAT WAY THEY DO NOT MOVE AT ALL, I HAD BETTER COMFORT WITH CHEAP LENSES THAT I GOT AT THE SWAPMEET. WHEN I EMAILED THEM STATING THEY SENT ME LENSES THAT WERE NOT TORIC THEY CLAIMED THAT THEY WOULD TAKE THE LENSES BACK ONLY IF THEY WERE IN THEIR SEALED GLASS BOTTLES THEY CAME IN, WHICH WOULD BE UTTERLY IMPOSSIBLE. THEY NEED TO BE STOPPED THEY ARE ROBBING PEOPLE AND MAKING PATIENTS VISION WORSE. I STRUGGLE NOW EVEN WITH MY NORMAL CONTACTS IN BECAUSE THEY MADE MY EYES SO MUCH WORSE THAN THEY WERE!

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
885919 SOLOTICA HIDROCOR TORIC FOR ASTIGMATISM LENSES, SOFT CONTACT, DAILY WEAR LPL SOLOTICA INDUSTRIA E COMERCIO LTDA IPANEMA

Patients

Seq Age Sex Outcome Treatment
1 33 YR Female