BEUDAMED
    FDA Adverse Event Other Summary report: N

    CILCO UV INTRAOCULAR LENS IMPLANT

    MDR report key: 66110 · Received January 3, 1997

    Report

    Report Number
    66110
    Event Type
    Other
    Date Received
    January 3, 1997
    Date of Event
    December 2, 1996
    Report Date
    December 10, 1996
    Manufacturer
    CILCO ALCON LABORATORIES, INC.
    Product Code
    HQL
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING INSERTION OF LEFT INTRAOCULAR LENS IMPLANT, INITIAL LENS SANK TO THE BOTTOM OF THE VITREOUS OF THE LEFT EYE. MD DID NOT ATTEMPT REMOVAL TO MINIMIZE VISUAL IMPAIRMENT AND A SECOND LENS WAS INSERTED. AFTER SURGERY THE PT WS DISCHARGED HOME. FULL EXTENT NOT VISUAL IMPAIRMENT CAN NOT BE DETERMINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CILCO UV INTRAOCULAR LENS IMPLANT Implant INTRAOCULAR LENS HQL CILCO ALCON LABORATORIES, INC. MC 52BM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other PT TO BE FOLLOWED BY MD OUTPATIENT POSTOPERATIVELY