BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI FEMTOSECOND SURGICAL LASER

    MDR report key: 2886930 · Received August 25, 2012

    Report

    Report Number
    3004858034-2012-00001
    Event Type
    Injury
    Date Received
    August 25, 2012
    Date of Event
    July 6, 2012
    Report Date
    August 23, 2012
    Manufacturer
    ZIEMER OPHTHALMIC SYSTEMS AG
    Product Code
    GEX
    PMA / PMN Number
    K053511
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CLAIMED THAT A LINE OF TISSUE HAD APPARENTLY NOT BEEN PROPERLY CUT AND REMAINED ATTACHED, WHEREAS THE FLAP ON EITHER SIDE CAME AWAY IN SEPARATE LOBES. WE ASKED FOR MORE DETAILED INFORMATION AND A SKETCH OF THE PROBLEM. NO GRAPHIC WAS GIVEN. THE OPERATOR CONFIRMED THAT THE FEMTO WORKED WITHOUT PROBLEMS BEFORE AND AFTER THIS CASE. UPON INSPECTION OF THE INTERSHIELD USED, HE FOUND A LINEAR MARK ON IT. FROM THIS HE CONCLUDED A CAUSAL CONNECTION WITH THE UNCUT LINE; HOWEVER, WE ARE QUIRE SURE HE COULD NOT CONFIRM WHETHER THE ORIENTATION OF THE INTERSHIELD DURING THE PROCEDURE AND THE UNCUT LINE HAD CORRESPONDED. THE INTERSHIELD WAS RETURNED TO US FOR INVESTIGATION. THE PURPORTED LINEAR MARKING WAS CONFIRMED. CONSISTING OF A THIN ARRAY OF VERY TINY AND SHALLOW PARALLEL SCRATCH MARKS ACROSS THE ENTIRE FOIL. WE ARE NOT FAMILIAR WITH SUCH A PATTERN, AND WE CAN NOT TELL WHEN/HOW IT HAS APPEARED. WE PREPARED A TEST PROTOCOL FOR THE WET LAB IN ORDER TO TRY AND REPRODUCE THE PROBLEM WITH THE IS IN QUESTION ON PORCINE EYES. ALL CUTS (ABOUT 40) WERE FOUND TO BE NORMAL. THE IS WE INVESTIGATED HAD SHOWN OBVIOUS WEAR FROM ITS HANDLING BETWEEN THE OPERATION AND OUR TESTING, YET IT STILL WORKED PERFECTLY FINE ON THE LASER. CONSEQUENTLY, WE WOULD RULE OUT THE INTERSHIELD AS THE IMMEDIATE CAUSE OF THE PROBLEM. THIS; HOWEVER, LEAVES US WITHOUT AN EXPLANATION OF THE ROOT CAUSE OF THE APPARENT MALFUNCTION.

    Description of Event or Problem · 1

    VOLUN (B)(6) 2012: DURING LASIK PROCEDURE, ZIEMER FEMTOSECOND LASER CREATED A LINEAR PATTERN ON RIGHT EYE THAT DID NOT CUT. PRIOR TO SURGEON LIFTING THE FLAP, FLAP APPEARED NORMAL. WHEN SURGEON ATTEMPTED TO LIFT THE FLAP, IT WAS SPLIT INTO SECTIONS WITH A REMAINING, ATTACHED CENTER SLIVER. SURGERY WAS ABORTED. BANDAGE CONTACT LENS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI FEMTOSECOND SURGICAL LASER POWERED LASER SURGICAL INSTRUMENT GEX ZIEMER OPHTHALMIC SYSTEMS AG 9.0 90

    Patients

    Seq Age Sex Outcome Treatment
    1 Other