BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK -- IOL

    MDR report key: 1343186 · Received March 12, 2009

    Report

    Report Number
    1119421-2009-00206
    Event Type
    Injury
    Date Received
    March 12, 2009
    Report Date
    February 10, 2009
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO MANUFACTURING DOCUMENTATION. THE SURGEON DID NOT USE THIS DEVICE AS INSTRUCTED IN THE DIRECTIONS FOR USE (DFU). LITERATURE CITED: CHANG SH, LIM G. (2004). SECONDARY PIGMENTARY GLAUCOMA ASSOCIATED WITH PIGGYBACK INTRAOCULAR LENS IMPLANTATION. J CATARACT REFRACTIVE SURGERY, OCT 30 (10), 2219-22. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE REPORTED A PATIENT DEVELOPED BILATERAL PIGMENTARY GLAUCOMA WITH UNCONTROLLED INTRAOCULAR PRESSURE (IOP), AND SIGNS OF PIGMENTARY DISPERSION SYNDROME AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE SULCUS AS A PIGGYBACK IOL. THIS IOL WAS IMPLANTED AS A PIGGYBACK LENS TO TREAT A HIGH MYOPIC OUTCOME WITH ANOTHER IOL (MODEL UNKNOWN) WHICH WAS IMPLANTED IN THE CAPSULAR BAG. THE HAPTICS AND THE EDGE OF THE PIGGYBACK LENS WERE REPORTED TO HAVE BEEN CHAFING THE POSTERIOR SURFACE OF THE IRIS. THE PIGGYBACK IOL WAS EXPLANTED; THE PATIENT'S IOP STABILIZED FOLLOWING TREATMENT WITH MEDICATIONS. THIS ARTICLE EMPHASIZED THE IMPORTANCE OF CHOOSING THE CORRECT TYPE OF IOL FOR SULCUS IMPLANTATION IN ORDER TO AVOID THE COMPLICATION OF PIGMENTARY DISPERSION SYNDROME. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS IS ONE OF TWO MEDICAL DEVICE REPORTS BEING FILED FOR THIS EVENT; THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK -- IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention