BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2222083 · Received August 24, 2011

    Report

    Report Number
    2023826-2011-00721
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 26, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: VISUAL INSPECTION OF THE RETURNED LENS SHOWED THE LENS WAS RETURNED DRY, PIECES OF THE HAPTICS WERE MISSING AND A DARK SURGICAL RESIDUE ON THE SURFACE OF THE LENS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED THE (B)(4) IMPLANTABLE COLLAMER LENS UPSIDE DOWN AND THE LENS WAS REMOVED IMMEDIATELY WITHOUT ANY PATIENT INJURY. THE REPORTER STATED THE INCIDENT WAS THE RESULT OF THE LENS NOT BEING PROPERLY ALIGNED IN THE INJECTION SYSTEM DURING LOADING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY MICL13.2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR FOAM TIP PLUNGER MODEL, LOT NUMBER UNK| CARTRIDGE MODEL SFC-45FP, LOT NUMBER UNK| INJECTOR MODEL MSI-PF, LOT NUMBER UNK