FDA Adverse Event Injury Summary report: N

CHROMAGENLENSES AT I READ BETTER N

MDR report key: 9451318 · Received December 10, 2019

Report

Report Number
MW5091570
Event Type
Injury
Date Received
December 10, 2019
Date of Event
December 6, 2019
Report Date
December 6, 2019
Manufacturer
CANTOR AND NISSEL LTD.
Product Code
NCZ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
IN, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I WENT TO OSSIP OPTOMETRY IN (B)(6) TO ORDER CHROMAGEN LENSES. IT TOOK OVER A MONTH TO ARRIVE BUT, I GOT THEM. THEY HELP WITH BEING COLOR BLIND BY THE WAY. I FINALLY GOT MY PAIR TODAY ONE INSTANTLY WENT OFF MU FINGER AND INTO THE SINK. A LOT HEAVIER THAN MY DAILY CONTACTS. KEEP IN MY MIND YOU ONLY GET TWO SETS OF CONTACTS FOR THE YEAR FOR (B)(6). ANYHOW, I WENT TO PUT MY OTHER CONTACT IN JUST TO TRY IT OUT SINCE THE OTHER SET ISN¿T HERE. I GOT THIS INSTANT BURNING IN MY LEFT EYE AND I YELLED OUT. MY LEFT EYE GOT RED AND STARTED TO BURN BADLY. IT¿S VERY DRY NOW. THE BURNING HAS STARTED TO DECREASE. I TRIED TO CALL MY THE MANUFACTURER FOR THE CHROMAGEN LENSES IN THE US NO ONE ANSWERED THE PHONE AT 4:45 PM EST TO REPORT THIS AND TO FIND OUT IF THIS WAS A STRONGER NORMAL SALINE SOLUTION THAN WHAT I¿M USE TO. MAYBE HYDROGEN PEROXIDE OR SOMETHING ELSE. ¿I THINK THEIR SITE IS I READ BETTER NOW.¿ I HAVE MY EYE WASHED OUT A FEW TIMES AND CALLED OSSIP ON (B)(6) AND EMAILED THEM A FEW TIMES ABOUT THIS. TORI THE GIRL I SPOKE WITH ISN¿T THE EYE DOCTOR. MY WIFE CALLED THEM AND ASKED WHAT SOLUTION WAS THE CONTACT CASE SINCE IT BURNED MY EYES SO BAD AND I WEAR CONTACTS DAILY. SHE SAID THE CONTACT LENSES THAT THEY WERE SENT IN DOEN¿T SAY ANYTHING BUT SHE THINKS SALINE. MY QUESTION IS DO CHROMAGEN LENSES GET SHIPPED IN A DIFFERENT SOLUTION SINCE THEY HAVE A DYE AND NEED TO LAST FOR SIX MONTHS. OR, WAS THIS AN ACCIDENTAL SOLUTION? OR, A STRONG SALINE? MY EYE BURNING IS DECREASING AFTER MAYBE A FEW HOURS BUT HAS THAT DRY HAZY LOOK AT TIMES. THANKS .(B)(6)

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1241356 CHROMAGENLENSES AT I READ BETTER N LENS, CONTACT, FOR COLOR VISION DEFICIENCY NCZ CANTOR AND NISSEL LTD.

Patients

Seq Age Sex Outcome Treatment
1 43 YR Other