BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELASTIC UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR

    MDR report key: 744818 · Received June 24, 2005

    Report

    Report Number
    2023826-2005-00816
    Event Type
    Malfunction
    Date Received
    June 24, 2005
    Date of Event
    May 25, 2005
    Report Date
    May 26, 2005
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H6: EVALUATION: VISUAL INSPECTION OF THE LENS SHOWED ONE HAPTIC WAS TORN AND THERE WAS EVIDENCE OF SURGICAL RESIDUE. AN MTC-60C FP CARTRIDGE, LOT NUMBER 1199167, WAS RETURNED, AND APPEARS UNUSED. SFC-25 FP CARTRIDGE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE NURSE STATED A TORIC SILICONE LENS MODEL AA4203TF TORE DURING INSERTION. THE LENS WAS IMPLANTED AND REMOVED WITHOUT PATIENT INJURY. THE NURSE STATED THE MSI-TR INJECTOR, LOT NUMBER UNKNOWN, AND THE SFC-25 FP CARTRIDGE, LOT NUMBER 1169641, WERE USED DURING SURGERY. THE NURSE WAS AWARE THAT THE INCORRECT CARTRIDGE WAS USED WITH THIS PARTICULAR LENS AND INJECTOR THAT WAS USED. THE NURSE ALSO WANTED TO CONFIRM THAT THE MTC-60C FP CARTRIDGE IS THE RECOMMENDED CARTRIDGE TO USE WITH THE TORIC SILICONE LENS AND MSI-TR INJECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELASTIC UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR