BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2991789 · Received March 6, 2013

    Report

    Report Number
    2023826-2013-00196
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS WITH ASPHERIC. NO KNOWN CONSEQUENCES OR IMPACT TO THE PATIENT. TORN MATERIAL. EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED LENS SHOWED THE LENS WAS RECEIVED IN LIQUID, TORN INTO THREE PIECES AND A PIECE OF THE OPTIC WAS TORN OFF AND MISSING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CC4204A +23.0 DIOPTER COLLAMER SINGLE PIECE LENS TORE AS THE SURGEON WAS INSERTING IT. THE LENS WAS CUT AND REMOVED FROM THE EYE WITHOUT ANY PATIENT INJURY. THIS IS ONE OF TWO LENSES THE SURGEON ATTEMPTED TO INSERT IN THIS PATIENT. THE THIRD LENS WAS SUCCESSFULLY IMPLANTED. THE REPORTER STATED A NEW TECH WAS BEING TRAINED AND THE INCIDENT WAS THE RESULT OF A TECH/LOADING ERROR. SEE MANUFACTURER REPORT #2023826-2013-00197.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95919 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR FTP INDIGO MODEL, LOT NUMBER UNKNOWN| SFC-25 FP CARTRIDGE MODEL, LOT NUMBER UNKNOWN| INDIGO-P INJECTOR MODEL, LOT NUMBER UNKNOWN