BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEEON

    MDR report key: 2824837 · Received November 8, 2012

    Report

    Report Number
    9614546-2012-00189
    Event Type
    Injury
    Date Received
    November 8, 2012
    Date of Event
    July 1, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S DOCTOR STATED THAT THE PATIENT HAD A DISLODGED LENS WHICH WAS ENGAGING THE IRIS WHICH PRODUCED CHRONIC IRITIS. FURTHER, THE DOCTOR REPORTED THAT THE ISSUE WAS NOT PRODUCT RELATED, RATHER, THE ISSUE WAS THE POSITIONING OF THE LENS CAUSED WHEN THE PATIENT WAS WRESTLING. THE PATIENT'S OPHTHALMOLOGIST PRESCRIBED STEROIDS FOR THE INFLAMMATION; AND REPORTS THE PATIENT HAS BEEN TAPERED OFF THE STEROIDS AND WOULD BE SEEN AGAIN FOR FOLLOW UP. THE INTRAOCULAR LENS REMAINS IMPLANTED TO DATE. A REVIEW OF THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS SHOWED NO DEVIATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A MOTHER REPORTED HER (B)(6) SON HAD AN INTRAOCULAR LENS IMPLANTED IN THE RIGHT EYE IN 1999 (WHEN HE WAS (B)(6)) AND THAT IN (B)(6) 2012 BEGAN TO EXPERIENCE REDNESS, SWELLING AND HIS EYE FELT HARDER THAN THE OTHER EYE. IN FOLLOW UP THE REPORTER INDICATED THEY HAD SEEN A DOCTOR AND WERE TOLD THAT IT APPEARED THE LENS HAD BEEN DISPLACED AND IT LOOKED LIKE IT WAS TOUCHING THE IRIS. HE WAS PRESCRIBED 2% PREDNISONE. FOLLOW UP WITH THE TREATING OPHTHALMOLOGIST CONFIRMED THE REPORTER'S ACCOUNT OF THE EVENT. HE INDICATED THAT THE POSITION OF THE LENS HAD NEVER BEEN PERFECT WITH THE TEMPORAL HAPTIC RESTING ON THE IRIS. THE EXAM ON (B)(6) 2012 FOUND THE HAPTIC IN THE SAME POSITION AS IN 2010. THERE WAS A TRACE INFLAMMATION IN THE EYE THAT COULD BE RELATED TO THE POSITION OF THE IOL. TRAUMATIC DISLOCATION IS HIGHLY SUSPECT DUE TO THE PATIENT'S HISTORY OF WRESTLING ALTHOUGH NO INCIDENT WAS NOTED. SINCE THE PATIENT IS LEGALLY BLIND IN THIS EYE, REPOSITIONING THE LENS COULD CAUSE "MORE PROBLEMS THAN GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEEON MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS 811A

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention