BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFLEX THREE-PIECE FOLDABLE LENS

    MDR report key: 219223 · Received April 15, 1999

    Report

    Report Number
    2023366-1999-00014
    Event Type
    Injury
    Date Received
    April 15, 1999
    Date of Event
    February 2, 1999
    Report Date
    March 23, 1999
    Manufacturer
    CHIRON VISION CORP.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED ENDOPHTHALMITIS AND A VITRECTOMY WAS PERFORMED. THE LENS REMAINS IMPLANTED IN THE PT'S EYE. THE ENDOPHTHALMITIS HAS RESOLVED AND THE PT'S PROGNOSIS IS GOOD. IT IS UNK IF THE ENDOPHTHALMITIS IS PRODUCT RELATED.

    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 75 YR Required Intervention MPORT MULTI-PC FOLDABLE LENS PLACEMENT.