BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2183313 · Received July 28, 2011

    Report

    Report Number
    2023826-2011-00684
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 1, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS. VISUAL INSPECTION OF THE RETURNED LENS SHOWED THE LENS WAS RETURNED DRY AND A PIECE OF BOTH THE OPTIC AND A HAPTIC WAS TORN OFF AND MISSING. THERE WAS A DARK SURGICAL RESIDUE ON THE SURFACE OF THE LENS. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT, LENS INSERTED UPSIDE DOWN. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON WAS HAVING DIFFICULTY LOADING THIS MICL13.7 IMPLANTABLE COLLAMER LENS AND WHEN IT WAS INSERTED IT FLIPPED UPSIDE DOWN. THE SURGEON COULD NOT GET THE LENS TO SEAT PROPERLY IN THE EYE AND TORE THE LENS WHILE REMOVING IT. THERE WAS NO PATIENT INJURY. THE REPORTER STATED THE INCIDENT WAS THE RESULT OF A LOADING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY MICL13.7 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE: MODEL SFC-45FP, LOT NUMBER UNKNOWN