BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK - IOL

    MDR report key: 1914336 · Received November 15, 2010

    Report

    Report Number
    1119421-2010-01258
    Event Type
    Other
    Date Received
    November 15, 2010
    Report Date
    October 16, 2010
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    HQL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE, THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FIVE YEARS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT IS EXPERIENCING DECREASED VISUAL ACUITY WITH A MYOPIC SHIFT. THE SURGEON REPORTED THAT A SLIT LAMP EVAL REVEALED WHAT APPEARED TO BE OPACIFIED VISCOELASTIC BEHIND THE IOL. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other