FDA Adverse Event Injury Summary report: N

CLEAR CARE

MDR report key: 5187160 · Received October 26, 2015

Report

Report Number
MW5057425
Event Type
Injury
Date Received
October 26, 2015
Date of Event
January 1, 2012
Report Date
June 4, 2012
Product Code
LPN
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I RECENTLY WENT ON A VACATION WITH SEVERAL FRIENDS, ALL OF WHO HAPPEN TO WEAR CONTACTS. ONE NIGHT I MISTAKENLY GRABBED A FRIEND'S CONTACT LENS SOLUTION, CLEAR CARE, AND USED IT TO STORE MY CONTACTS IN OVERNIGHT. THE NEXT MORNING WHEN I PUT BY CONTACT BACK IN MY EYE, I EXPERIENCED EXCRUCIATING PAIN AND BURNING. I MANAGED TO TAKE THE CONTACT BACK OUT OF MY EYE WITHIN SECONDS, BUT STILL SUFFERED OVER A DAY'S WORTH OF PAIN. THE PAIN WAS UNBELIEVABLE AFTER SUCH A SHORT EXPOSURE, MY EYE WAS BRIGHT RED, BURNING AND TEARING. CLEAR CARE USES HYDROGEN PEROXIDE IN THEIR SOLUTION AND IS NOT INTENDED FOR DIRECT CONTACT WITH EYES. AFTERWARDS, I CHECKED THE BOTTLE AND ONLY THEN DID I NOTICE THE THIN RED WARNING ALONG THE TOP OF THE BOTTLE. THE WARNING DID NOTHING TO PREVENT ME FROM MAKING THE SIMPLE MISTAKE OF SWITCHING THE BOTTLE WITH MY OWN AND I DO NOT UNDERSTAND WHY CLEAR CARE WOULD NOT CHANGE THE DESIGN OF THEIR BOTTLE TO MAKE CONSUMER'S MORE LIKELY TO STOP AND READ THE LABELS MORE CLOSELY. AS A LIFELONG CONTACT USER, I DO NOT REPEATEDLY READ THE INSTRUCTIONS OR LABELS ON CONTACT LENS SOLUTION BOTTLES SINCE I AM WELL AWARE ON HOW TO USE THEM. IF THE DESIGN OF THE BOTTLE WAS DIFFERENT FROM OTHER SOLUTIONS, CONSUMERS WOULD BE LESS LIKELY TO MAKE THIS HORRIBLY PAINFUL MISTAKE. IT IS SUCH AN EASY MISTAKE TO MAKE THE WARNING IS INADEQUATE AND DOES NOT EFFECTIVELY PREVENT INJURIES. MEDICATION ADMINISTERED TO OR USED BY THE PT: NO. PT COUNSELING PROVIDED: UNK. REPORTER'S RECOMMENDATION: THE PACKAGING OF THIS PRODUCT SHOULD NOT BE SO SIMILAR TO OTHER REGULAR SALINE SOLUTIONS. IT IS NOT A TYPICAL CONTACT LENS SOLUTION AND SHOULD NOT BE PACKAGED AS SO. CHANGING THE DESIGN OR APPEARANCE WOULD B E A SIMPLE AND EFFECTIVE WAY OF PREVENTING MIS UPS WITH OTHER NORMAL SOLUTIONS. SEVERITY: ERROR RESULTED IN TREATMENT OR INTERVENTION; TEMPORARY PT HARM. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
709563 CLEAR CARE CLEAR CARE LPN

Patients

Seq Age Sex Outcome Treatment
1 UNK