FDA Adverse Event Malfunction Summary report: N

FRESH COLORBLENDS

MDR report key: 11965763 · Received June 8, 2021

Report

Report Number
MW5101767
Event Type
Malfunction
Date Received
June 8, 2021
Date of Event
June 5, 2021
Report Date
June 5, 2021
Manufacturer
ALCON RESEARCH, LLC
Product Code
LPL
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MD, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

VISION WAS IMPAIRED; ON MAY 31ST I DECIDED TO TRY OUT A NEW COMPANY THAT LISTED CHEAPER PRESCRIPTION CONTACT LENSES. THERE WAS A 4 STEP PROCESS TO CONFIRM THE ORDER. THE SECOND STEP WAS PAYMENT INFO. ON THAT PAGE, I NOTICED THAT THEY NEEDED TO CONTACT MY EYE DOCTOR AND I EXITED THE PAGE. MY PLAN WAS TO LET THE WEEKEND AND HOLIDAY PASS SO THAT I COULD CALL MY DOCTOR FOR INSTRUCTIONS ON ORDERING FROM THEM. ALMOST AS SOON AS I LEFT THE PAGE I GOT A RECEIPT IN MY EMAIL FOR CONTACT LENS. I HAD NO CLUE IF THE ORDER WAS BECAUSE I LEFT THE PAGE AND DIDN'T CONFIRM THE ORDER. MY DOCTOR'S OFFICE WAS NOT OPEN ON MAY 31ST TO VERIFY THE PRESCRIPTION. I CALLED THEM AT (B)(6) AND SENT EMAILS TO TELL THEM THAT I DID NOT CONFIRM THE PURCHASE BUT GOT NO RESPONSE. EVEN THOUGH I DIDN'T GET A RESPONSE THEY MADE SURE TO LET ME KNOW WHEN THE ORDER WAS SHIPPED AND HOW TO TRACK IT. I CONTACTED MY BANK TO MAKE THEM AWARE OF THE SITUATION AND THAT I WANTED MY MONEY REFUNDED. FINALLY, SOMEONE CALLED ME BACK ON TUESDAY AND SAID THEY WOULD SEND A PRE-PAID LABEL TO SEND THEM BACK FOR A REFUND. WHEN THE CONTACTS ARRIVED ON JUNE 5TH, I WAS GOING TO KEEP THEM AS AN EXTRA SET BECAUSE I ALREADY PLACED AN ORDER WITH MY USUAL COMPANY, (B)(6). I TRIED (B)(6) CONTACTS LENS WHILE WEARING MY CURRENT LENS TO FIND THAT THEY WERE JUST COLOR LENS. THEY ARE LABEL AS A PRESCRIPTION BUT THE BOX IS DIFFERENT FROM WHAT I NORMALLY GET. I PACKAGED IT UP AFTER TAKING PICTURES. I WAS GOING OUT TO DRIVE AND COULD HAVE GOTTEN INTO AN ACCIDENT BECAUSE I COULDN'T SEE OUT OF THEIR 1 LENS. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
859496 FRESH COLORBLENDS LENSES, SOFT CONTACT, DAILY WEAR LPL ALCON RESEARCH, LLC UPC: 7-30821-59898-0 VER: 01/ 31414643

Patients

Seq Age Sex Outcome Treatment
1 45 YR Other