BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFLEX THREE-PIECE FOLDABLE LENS

    MDR report key: 223290 · Received April 30, 1999

    Report

    Report Number
    2023366-1999-00016
    Event Type
    Injury
    Date Received
    April 30, 1999
    Date of Event
    March 11, 1999
    Report Date
    March 31, 1999
    Manufacturer
    CHIRON VISION CORP.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTED POSTOPERATIVE REFRACTIVE ERROR. LENS WAS EXPLANTED ON 3/25/1999. CAUSE OF REFRACTIVE ERROR IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFLEX THREE-PIECE FOLDABLE LENS Implant INTRA OCULAR LENS HQL CHIRON VISION CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1