BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIEMMER CRYSTALLINE

    MDR report key: 7218704 · Received January 23, 2018

    Report

    Report Number
    7218704
    Event Type
    Injury
    Date Received
    January 23, 2018
    Date of Event
    June 23, 2017
    Report Date
    December 27, 2017
    Manufacturer
    ZIEMER USA INC.
    Product Code
    OOE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CRYSTALLINE LASER WAS SUBSTITUTED THIS PROCEDURE DAY DUE TO A MALFUNCTION OF THE Z4 LASER THAT WAS SCHEDULED TO BE USED. THIS LASER WAS BORROWED FROM ANOTHER LASIK SURGEON IN THE AREA WHO DID SAY THAT THEY HAVE HAD ENERGY LEVEL ISSUES WITH THE LASER IN THE PAST. WHEN I CONSULTED THE ZIEMER REP, HE STATED THEY HAD DONE DIAGNOSTIC TESTING AND THE LASER WAS SAFE TO USE. AT THE END OF THE SURGERY DAY, THE CRYSTALLINE LOST ENERGY. THE ZIEMER TECH WHO WAS ASSISTING IN SURGERY THIS DAY READJUSTED SETTINGS AND SAID IT WAS SAFE TO PROCEED. THE SURGERY WAS COMPLETED. THE NEXT DAY THE PT HAD SIGNIFICANT DLK THAT WAS TREATED WITH A FLAP LIFT AFTER 2 WKS OF TOPICAL MEDICAL TREATMENT. MDR FILE DATE: 12/27/2017. THE PT IS NOW SEEING 20/20 OUT OF THE EYE BUT HAD SIGNIFICANT VISUAL AND COMFORT COMPLICATIONS AFTER PROCEDURE UNTIL CURRENTLY. FILING A REPORT WITH THE FDA TO INSURE THAT PARTICULAR CRYSTALLINE LASER IS NOT USED FOR ANY OTHER TREATMENTS. (B)(6), RN, OD. (B)(6) 2017, I WAS THE ZIEMER TECH DURING THE LASIK OU SURGERY FOR PT (B)(6) ON (B)(6) 2017. HER RIGHT EYE WENT FROM START TO FINISH WITHOUT INCIDENT OR NOTABLE ACTIVITY. WHEN IT WAS TIME TO CREATE THE FLAP USING THE ZIEMER ON HER LEFT EYE, THE ENERGY LEVEL IN THE ZIEMER (FEMTO LDV CRYSTALLINE) DROPPED AND THE YELLOW WARNING LIGHT CAME ON. AS A RESULT, WE WERE UNABLE TO APPLY THE VACUUM. I LOOKED TO THE ZIEMER TECH/TRAINER THERE THAT DAY FOR GUIDANCE AS WE HAD NEVER HAD ANYTHING LIKE THAT HAPPEN IN THE PAST. HE MADE A NEW ADJUSTMENTS TO SOME SETTINGS AND TURNED THE SCREEN BACK TO ME, SAYING IT WAS SAFE TO USE. IN CONFIRMED THAT WE WERE OK TO PROCEED AND HE AGAIN SAID IT WAS GOOD TO GO. WE CONTINUED WITH HER SURGERY AS NORMAL. (B)(6), PT CARE TECH/LASER TECH/COA. SURGEON REPORT: IN THE SURGICAL SUITE ON PT (B)(6) ON (B)(6) 2017, THE POWER DROPPED TO AN UNSAFE LEVEL FOLLOWING FLAP CREATION ON THE RIGHT EYE. THE ZIEMER TECH, WHO WAS PRESENT TO OVERSEE PROCEDURES THAT DAY, ADJUSTED THE POWER ON THE LASER BETWEEN THE RIGHT AND LEFT EYE. THE FLAP CREATION ON THE LEFT EYE WAS SUCCESSFUL FOLLOWING THE POWER ADJUSTMENT. FOLLOWING SURGERY, THE POSTOPERATIVE COURSE RIGHT EYE WAS UNEVENTFUL WITH 20/15 VISION. IN LEFT EYE, PT DEVELOPED DIFFUSE LAMELLAR KERATITIS AND 360 DEGREES OF EPITHELIAL INGROWTH WHICH REQUIRED A FLAP LIFT AND EPITHELIAL REMOVAL AT 1 WEEK POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55834 ZIEMMER CRYSTALLINE FEMTOSECOND LASER OOE ZIEMER USA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention