FDA Adverse Event Malfunction Summary report: N

ALCON CLEAR CARE

MDR report key: 5360781 · Received January 8, 2016

Report

Report Number
MW5059220
Event Type
Malfunction
Date Received
January 8, 2016
Date of Event
December 11, 2015
Report Date
December 12, 2015
Manufacturer
ALCON
Product Code
LPN
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CT, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I USE THE CLEAR CARE 3% HYDROGEN PEROXIDE CLEANING SYSTEM TO DISINFECT MY SOFT CONTACT LENSES. THERE IS A DISC PROVIDED THAT NEUTRALIZES THE DISINFECTING SOLUTION INTO A SAFE SALINE. ACCORDING TO THE INSTRUCTIONS, THE LENSES CAN BE WORN (WITHOUT RINSING) AFTER SOAKING FOR 6 HOURS. A FEW MONTHS AGO, I PURCHASED A NEW BOX OF SOLUTION THAT COMES WITH A CUP AND DISC TO USE. I NOTICED THE STYLE OF CUP HAD CHANGED. I USED THE PRODUCT AS I HAVE FOR MANY YEARS, AND MY EYES WERE BURNED (NOT TO THE POINT REQUIRING MEDICAL ATTENTION) WHEN I PLACED THE LENSES ONTO MY EYES (AND THAT WAS AFTER RINSING THE LENSES WITH STERILE SALINE - A STEP THAT IS NOT REQUIRED BUT I HAVE ALWAYS DONE TO BE SAFE). I REPEATED THE PROCESS THE NEXT TWO NIGHTS WITH THE SAME RESULTS. I CALLED THE ALCON COMPANY TO REPORT THAT THE NEUTRALIZING DISC APPEARED NOT TO BE DOING ITS JOB AND THAT I'D EXPERIENCED PAINFUL BURNING FOR THREE MORNINGS IN A ROW. THE COMPANY SHIPPED ME REPLACEMENT PRODUCTS (WITH THE OLD-STYLE CASE AND DISC) AND A COUPON FOR MY NEXT PURCHASE. AFTER USING THE REPLACEMENT PRODUCT, I PURCHASED ANOTHER SET. I EXPERIENCED THE SAME BURNING AS BEFORE. CLEARLY, THE NEW-STYLE CUPS COME WITH FAULTY DISCS THAT ARE NOT NEUTRALIZING THE SOLUTION. I CALLED ALCON AGAIN YESTERDAY AND LEFT A MESSAGE TO REPORT THE PROBLEM. I DON'T KNOW IF"SERIOUS" INJURIES CAN OCCUR FROM THIS PROBLEM, BUT THE PAIN IS BAD ENOUGH THAT I'M CONSIDERING SWITCHING TO AN ENTIRELY DIFFERENT DISINFECTION SYSTEM. IN CASE YOU'D LIKE TO KNOW, THE LOT NUMBER ON MY MOST RECENT PACKAGE IS 241784 AND IT EXPIRES 08/2017. THANK YOU. (B)(6). PURCHASE DATE: (B)(6) 2015. THE PRODUCT WAS NOT DAMAGED BEFORE THE INCIDENT. THE PRODUCT WAS NOT MODIFIED BEFORE THE INCIDENT. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
13164 ALCON CLEAR CARE CLEAR CARE 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOLUTION LPN ALCON

Patients

Seq Age Sex Outcome Treatment
1 44 YR