BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTALCARE

    MDR report key: 4685925 · Received April 13, 2015

    Report

    Report Number
    3004537773-2015-00004
    Event Type
    Injury
    Date Received
    April 13, 2015
    Date of Event
    February 22, 2015
    Report Date
    March 9, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT PROVIDED A NON-VALID LOT NUMBER AND THEREFORE THE EXPIRATION DATE IS UNKNOWN. CONCOMITANT PRODUCTS AIR OPTIX SOFT CONTACT LENSES. PMA 510(K): P870026. ALTERNATIVE REPORT IDENTIFICATION NUMBER (B)(4). SECTION F COMPLETED BY THE MANUFACTURER (B)(4). MFG DATE: UNKNOWN AS THE LOT NUMBER WAS NOT PROVIDED ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD MALE PATIENT REPORTED HE EXPERIENCED A STINGING SENSATION, PAIN AND BLURRED VISION (LATER DIAGNOSED AS DIPLOPIA) AFTER MISUSING TOTAL CARE DAILY CLEANER AS A MULTIPURPOSE SOLUTION FOR HIS SOFT CONTACT LENSES. THE REPORTER INDICATED HE THOUGHT THE PRODUCT WAS A MULTIPURPOSE SOLUTION AND RINSED AND STORED HIS LENSES OVERNIGHT. IN THE MORNING HE RINSED THEM AGAIN WITH THE DAILY CLEANER AND INSERTED THEM INTO HIS EYES. HE REMOVED THEM FROM HIS EYES AND BECAUSE HE WAS VERY UNCOMFORTABLE, HE SOUGHT MEDICAL TREATMENT AND WAS DIAGNOSED WITH A CORNEAL BURN. HE WAS GIVEN DROPS FOR TREATMENT, TOLD TO DISCONTINUE THE USE OF CONTACT LENSES FOR ONE TO TWO WEEKS, AND AVOID SUNSHINE. HE WAS ALSO GIVEN AN EYE PATCH THAT WAS TO BE REMOVED IN A FEW HOURS. AFTER A FEW HOURS, MOST OF THE PAIN WAS GONE. THE FOLLOWING DAY THE PAIN WAS ¿GOOD AS GONE¿ BUT THE PATIENT¿S VISION IN THE RIGHT EYE WAS STILL BLURRED. ON (B)(6) 2015 HE SAW ANOTHER OPHTHALMOLOGIST FOR CHECK-UP. THE PAIN WAS GONE BUT VISION WAS STILL BLURRY. IN FOLLOW UP IT WAS LEARNED THE PATIENT PRESENTED WITH KERATITIS AND CORNEAL EROSION IN HIS RIGHT EYE. FOLLOW UP WITH HIS EYE CARE PROFESSIONAL FOUND THE PATIENT WAS PRESCRIBED ARTIFICIAL TEARS EYE DROPS (SYSTANE ULTRA), ONE DROP EVERY 8 HOURS AND OFTOL PLUS (LOTEPREDNOL AND TOBRAMYCIN) ONE DROP EVERY 8 HOURS FOR 5 DAYS TO CONTROL A PAINLESSLY SLIGHT RESIDUAL PUNCTATE KERATITIS. AT THIS TIME THE PATIENT STATES THAT THE BLURRY VISION IN THE RIGHT EYE CONTINUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244184 TOTALCARE SOLUTIONS LPN ABBOTT MEDICAL OPTICS 07529X UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention