FDA Adverse Event Injury Summary report: N

CLEAR CARE

MDR report key: 4295063 · Received November 24, 2014

Report

Report Number
MW5039322
Event Type
Injury
Date Received
November 24, 2014
Date of Event
November 23, 2014
Report Date
November 24, 2014
Manufacturer
CIBA VISION
Product Code
LPN
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

CIBA VISION CLEAR CARE CONTACT SOLUTION WAS ACCIDENTALLY USED WITHOUT NEUTRALIZING CASE. IMMEDIATELY EYE SWELLED SHUT WITH SUCH EXCRUCIATING PAIN THAT ASSISTANCE WAS REQUIRED FROM SOMEONE ELSE IN HOUSEHOLD TO REMOVE LENS FROM EYE AND FLUSH. WHEN CALLING MFR PHONE NUMBER ON BOTTLE WAS ADVISED THAT "THIS HAPPENS", WILL NOT CAUSE PERMANENT DAMAGE (THOUGH OTHER MEDICAL SOURCES INDICATE THAT HYDROGEN PEROXIDE IN THE EYE CAUSE PERMANENT DAMAGE) AND SIDE EFFECTS COULD LAST 24-48 HOURS. BUT, IF I FELT IT WAS NECESSARY, I COULD SEEK MEDICAL ATTENTION. TWENTY-FOUR HOURS LATER, EYE IS STILL PAINFUL, SEVERELY SWOLLEN AND WHITE OF EYE IS ENTIRELY BLOODSHOT. WHILE IT IS A CONSUMER'S REPRODUCTIBILITY TO REVIEW PRODUCT INSTRUCTIONS AND USE AS DIRECTED, THIS PACKAGING ABSOLUTELY NEEDS A CLEAR AND DIRECT WARNING. DIRECTIONS IN BOTTLE INSTRUCT USER TO ADD SOLUTION TO CLEAR CARE NEUTRALIZING CASE, BUT CONTAINS NO CLEAR VERBIAGE THAT USE IN A FLAT CASE CAN CAUSE SUCH SERIOUS SIDE EFFECTS. COUNTLESS HOUSEHOLDS IN THE US HAVE MULTIPLE CONTACT LENS WEARERS WITH CARE PRODUCTS STORED IN CENTRAL LOCATIONS, MAKING IT VERY EASY FOR THIS PRODUCT TO BE MISUSED WITHOUT MORE CLEAR AND DIRECT WARNINGS ON THE BOTTLE. PACKAGING IS IDENTICAL TO SALINE SOLUTION BOTTLES, AND EVEN THE SMALL WARNINGS THAT ARE PRINTED DO NOT REFERENCE ANY POTENTIAL OF ADVERSE EFFECTS WHEN PRODUCT IS NOT USED AS DIRECTED. LACK OF CLEAR WARNING ON THE CLEAR CARE BOTTLE IS VERY DANGEROUS TO CONSUMERS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
761999 CLEAR CARE CONTACT SOLUTION LPN CIBA VISION

Patients

Seq Age Sex Outcome Treatment
1 27 YR Other