BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LEN

    MDR report key: 896604 · Received October 12, 2004

    Report

    Report Number
    2023826-2004-01661
    Event Type
    Malfunction
    Date Received
    October 12, 2004
    Date of Event
    September 7, 2004
    Report Date
    September 14, 2004
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. THE LENS REMAINS IMPLANTED IN THE PT. HOWEVER, THE VISUAL INSPECTION OF THE CARTRIDGE SFC-25FP, LOT# 1189825 HAD EVIDENCE OF SURGICAL RESIDUE AND THE TIP WAS DAMAGED. THE INJECTOR, MSI-PF, LOT# UNK, HAD NO VISIBLE DAMAGE. THE FOAM TIP PLUNGER, LOT# 1189669 ALSO HAD NO VISIBLE DAMAGE.

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A COLLAMER LENS MODEL CC4204BF AND NOTED THE TRAILING HAPTIC WAS TORN. IT WAS INDICATED THAT THE SURGEON DECIDED TO LEAVE THE LENS IMPLANTED AND THERE WAS NO PT INJURY. AN MSI-PF INJECTOR, LOT NUMBER UNK, AN SFC-25 FP CARTRIDGE, LOT NUMBER 1189825, AND A FOAM TIP PLUNGER, LOT NUMBER 1189669 WERE USED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LEN INTRAOCULAR LENS HQL STAAR SURGICAL CO. CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR