FDA Adverse Event Malfunction Summary report: N

BIOFINIFY TORIC COMFILCON A

MDR report key: 10024569 · Received May 4, 2020

Report

Report Number
MW5094374
Event Type
Malfunction
Date Received
May 4, 2020
Date of Event
February 12, 2020
Report Date
May 1, 2020
Manufacturer
COOPERVISION, INC.
Product Code
LPM
UDI-DI
00829196941092
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
VA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

RETAILER: (B)(6), ORDER CONTACTS FROM RETAILER ON FEBRUARY 12TH. THESE WERE PAID FOR THROUGH MY EYE INSURANCE. RECEIVED WRONG CONTACTS FOR MY PRESCRIPTION. HAD A DIFFICULT TIME CONTACTING RETAILER. THE PHONE HAS LONG WAIT TIMES AS WELL AS THE WEB CHAT. THE WEB CHAT ADVISES YOUR QUE NUMBER AND AVERAGE TIME CUSTOMER HAS TO WAIT BUT WAIT TIMES CHANGE ANYWHERE BETWEEN 4 AND 12 MINS AND GOES UP AND DOWN EVERY FEW MINS. I WAS ABLE TO CONTACT AN AGENT TODAY AFTER A 2 HOUR WAIT. IN THE CHAT I WAS ADVISED, WHEN I ASKED, THAT PRESCRIPTIONS ARE SELDOM VERIFIED. WHEN I ASKED HOW MY LENSES GOT SENT WITHOUT A PRESCRIPTION GIVEN OR VERIFIED BY MY DOCTOR, THE AGENT ADVISED THAT IS RARE BUT THAT THEY ARE BUSY. I AM WAITING IN ANOTHER WEB CHAT FOR THE CHAT LOG OF MY CHAT EARLIER FOR REFERENCE. I'D LIKE TO NOTE I DID NOT FEEL A LOT OF RESPONSIBILITY WAS TAKEN FOR THIS MISTAKE AND I DIDN'T GET CLEAR ANSWERS. A RETURN WAS INITIATED AND I AM GOING TO SEND THE CONTACT LENSES BACK VIA A (B)(6) LABEL PROVIDED. HOWEVER, DUE TO THE LACK OF PRESCRIPTION VERIFICATION, HOW HARD IT IS TO GET INTO CONTACT WITH SOMEONE AT THIS RETAILER AND THE LACK OF CLEAR RESPONSE I AM AFRAID THE RETAILER MAY NEVER ADVISE ME WHEN THEY RECEIVE RETURN OR MY CONTACT LENSE EYE INSURANCE MONEY WON'T EVER BE RETURNED AND I WON'T BE ABLE TO REPURCHASE CORRECT LENSES FROM A LEGITIMATE RETAILER. I DO NOT BELIEVE THIS INCORRECT PRESCRIPTION RECEIVED WAS A FLUKE DUE TO THE RESPONSE IN THE WEB CHAT AND I THEREFORE WOULD LIKE TO REPORT THIS RETAILER AS ILLEGITIMATE AND BREAKING THE LAW. THANK YOU FOR YOUR TIME. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
483619 BIOFINIFY TORIC COMFILCON A LENSES, SOFT CONTACT, EXTENDED WEAR LPM COOPERVISION, INC. BIOFINIFY TORIC COMFILCON A (10): 122520500165100055 00829196941092

Patients

Seq Age Sex Outcome Treatment
1 32 YR