BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHACOFLEX II

    MDR report key: 3831189 · Received May 23, 2014

    Report

    Report Number
    2648035-2014-00262
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2003
    Report Date
    May 7, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP WITH THE PATIENT'S GLAUCOMA SPECIALIST WAS PERFORMED. THE DOCTOR INDICATED THAT AFTER SPEAKING WITH THE PATIENT HE FOUND THE PATIENT WAS MOSTLY INTERESTED IN LEARNING IF HIS INTRAOCULAR LENS (IOL) WAS A RECALLED LENS. HE DID NOT HAVE ANY SPECIFIC ISSUES WITH CLOUDINESS. THE DOCTOR INDICATED THAT WHATEVER VISUAL ISSUES HIS PATIENT IS HAVING IS DUE TO THE PROGRESSION OF HIS GLAUCOMA. HE STATED THAT THE NEXT TIME HE SEES THE PATIENT HE WILL EVALUATE HIS IOLS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). IOL REMAINS IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MFR: 05/21/2014. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT FROM A CONSUMER, WHO IS A RADIOLOGIST, WHO INDICATES THAT HIS LEFT 6.0 DIOPTER MONOFOCAL INTRAOCULAR LENS IS CLOUDY AND CAUSING PROBLEMS FOR HIM. HE RELATED THAT HE HAS EXPERIENCED PROBLEMS WITH CLOUDINESS SINCE THE IOL WAS IMPLANTED ON (B)(6) 2003. THE DIFFICULTY AFFECTS HIS ABILITY WITH FINE DETAILS AND CONTRAST SENSITIVITY. IN 2007 HE WAS DIAGNOSED WITH GLAUCOMA. IN FOLLOW UP, IT WAS LEARNED THAT IN 2009, HIS SYMPTOMS WORSENED AND HAS CENTRAL VISION LOSS DUE TO PROGRESSION OF THE GLAUCOMA. HE RELATED THAT HIS FUNDUS EXAMINATION WAS CLOUDY. HE HAD A YAG PROCEDURE PERFORMED ON THE LEFT EYE IN 2003 FOR POSTERIOR CAPSULAR OPACIFICATION. A TRABECULOPLASTY IS SCHEDULED FOR AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308215 PHACOFLEX II MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS SI40NB SI40NB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other