FDA Adverse Event Other Summary report: N

COMPLETE MULTI-PURPOSE

MDR report key: 1170065 · Received September 21, 2008

Report

Report Number
MW5008365
Event Type
Other
Date Received
September 21, 2008
Date of Event
August 6, 2008
Report Date
September 21, 2008
Manufacturer
ADVANCED MEDICAL OPTICS INC.
Product Code
LPN
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IN 2008, MY DAUGHTER STARTED USING COMPLETE MULTI-PURPOSE SOLUTION EASY RUB FORMULA TO CLEAN AND SOAK HER LENSES. SHE HAS BEEN WEARING SOFT DISPOSABLE LENSES FOR 5 YEARS, BUT HAD NEVER BEFORE USED THIS PRODUCT. ABOUT 2 WEEKS AFTER, SHE BEGAN TO EXPERIENCE SLIGHT PHOTOPHOBIA, HAD RED EYES, PAIN AND A SWOLLEN EYELID ON THE RIGHT SIDE. WE WENT TO SEE A GENERALIST AT STUDENT HEALTH, WHERE HER CONDITION WAS DIAGNOSED AS CONJUNCTIVITIS. SHE WAS PUT ON ANTIBIOTIC EYEDROPS FOR A WEEK, IN CASE THE PINK EYE WAS BACTERIAL RATHER THAN VIRAL, AND WAS NOT ALLOWED TO WEAR HER LENSES FOR 8 DAYS. THE SYMPTOMS SEEMS TO ATTENUATE, BUT WHEN SHE WOULD START TO WEAR HER LENSES AGAIN, THE SYMPTOMS WOULD INCREASE. WE HAD HEARD OF CASES OF PINK-EYE THAT WERE HARD TO SHAKE, AND DIDN'T THINK ANYTHING OF IT. THEN ON THE FOLLOWING MONTH, THE PHOTOPHOBIA INCREASED TO THE POINT THAT SHE COULD NOT OPEN HER EYES IF THERE WAS LIGHT IN THE ROOM, AND THE PAIN BECAME SO SEVERE THAT WE WENT TO THE ER OF HOSPITAL IN OTHER COUNTRY. THERE SHE WAS DIAGNOSED WITH KERATITIS, CONFIRMED 4 DAYS LATER BY HER OWN OPHTHALMOLOGIST, UNDER WENT INTENSIVE ANTIBIOTIC TREATMENT AND IS NOW CURED, 2 WEEKS LATER. DOSE OR AMOUNT: 3 DROPS RUBBED ON LENSES, FREQUENCY: SOAKING AT NIGHT, ROUTE: OTHER. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: DISINFECTION OF CONTACT LENSES. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 COMPLETE MULTI-PURPOSE EASY-RUB FORMULA LPN ADVANCED MEDICAL OPTICS INC. AD00345

Patients

Seq Age Sex Outcome Treatment
1 16 YR Other