FDA Adverse Event Injury Summary report: N

CLEAR CARE

MDR report key: 2878122 · Received December 12, 2012

Report

Report Number
MW5028215
Event Type
Injury
Date Received
December 12, 2012
Date of Event
January 1, 2012
Report Date
September 8, 2012
Product Code
LPN
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
OTHER CAREGIVERS

Narratives

Description of Event or Problem · 1

ACTUAL ERROR: YES. DESCRIPTION: THIS MORNING ((B)(6) 2012), MY WIFE DID SOMETHING SHE HAS DONE DAILY FOR MORE THAN 30 YEARS, PLACING CONTACT LENS IN HER EYES. BUT THIS TIME IT WAS DIFFERENT. SHE SUFFERED EYE BURNING AND EXCRUCIATING PAIN WHEN DOING THIS!. THE CAUSE OF THE PROBLEM IS THE LENS CLEANING SOLUTION CALLED CLEAR CARE BY CIBA VISION CORP. SHE THOUGHT THAT IT WAS JUST ANOTHER CLEANING SOLUTION LIKE THOSE SHE HAS USED FOR DECADES BECAUSE THE CARTON PACKAGE LOOKS JUST AS USUAL WITHOUT OBVIOUS WARNING MESSAGE ON THE CARTON PACKAGE. MEDICATION ADMINISTERED TO OR USED BY THE PATIENT: NO. TYPE OF STAFF MADE INITIAL ERROR: CONSUMER/FAMILY MEMBER/CAREGIVER. WHEN AND HOW WAS ERROR DISCOVERED: IT WAS THE FIRST TIME MY WIFE USED THE CLEAR CARE PRODUCT. NATURALLY, THE FOCUS WAS ON THE PRODUCT. AFTER TAKING A CLOSE LOOK, I SAW A NON OBVIOUS (SMALL FONT SIZE AND BLACK FONT COLOR) MESSAGE ON THE PACKAGE, WARNING/PRECAUTIONS: SEE INSIDE OF THIS CARTON. INGREDIENT CONTAINS A VERY CORROSIVE AGENT OF 3% HYDROGEN PEROXIDE, SOMETHING THAT YOU NEVER WANT YOUR EYES TO CONTACT WITH. WHEN I OPENED THE PACKAGE INSIDE OUT, THERE IS INDEED A WARNING MESSAGE WRITTEN IN RED. IT SAYS THAT FOLLOWING THE USUAL STEP OF CLEANING, THERE IS AN EXTRA 6 HOUR LONG STEP TO NEUTRALIZE THE SOLUTION ON THE LENS. WITHOUT THE EXTRA STEP, BURNING AND STINGING WILL RESULT. BUT IT WAS TOO LATE. DAMAGE HAS BEEN DONE, AND I DON'T KNOW THE LONG TERM CONSEQUENCE TO HER EYE. REPORTER'S RECOMMENDATIONS: NOT EVERYONE WILL GO THE EXTRA LENGTH TO OPEN THE PACKAGE INSIDE OUT TO READ INSIDE MESSAGE. MY WIFE IS LIKELY NOT ALONE. IN FACT, REPORTS OF THE SAME INCIDENTS SHOW UP AGAIN AND AGAIN ON THE WEB. IT APPEARS TO BE A WIDE SPREAD ISSUE FOR CONTACT LENS USERS. SOMETHING SHOULD BE DONE TO SOLVE THIS PROBLEM, SOONER RATHER THAN LATER. HERE IS A SIMPLE, ONCE AND FOR ALL SOLUTION: TAKE IT OFF THE SHELF IF IT IS NOT POSSIBLE, THE PACKAGE SHOULD BE REDESIGNED WITH THE WARNING MESSAGE IN BIG AND RED FONT IN THE FONT OF THE PACKAGE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CLEAR CARE CIBA VISION LPN

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention