BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE¿ SYSTEM

    MDR report key: 2874512 · Received December 14, 2012

    Report

    Report Number
    2020664-2012-00093
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 22, 2012
    Report Date
    May 14, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SALES REPRESENTATIVE REPORTED THAT HE TALKED TO THE SURGEON AND THE HANDPIECE DID NOT SEEM TO BE THE CAUSE OF THIS ISSUE. AFTER DISCUSSION WITH SURGEON, A RECENT CHANGE IN HER SURGICAL TECHNIQUE (2.2MM, LONGER, TIGHTER INCISION ARCHITECTURE PROBABLY ¿CHOKING¿¿ THE INFUSION FOR A BRIEF MOMENT LIMITING THE BALANCED SALT SOLUTION FROM COOLING THE TIP) AND THE PARTICULARITY OF THE PATIENT MIGHT HAVE CAUSED THE CORNEAL BURN.

    Additional Manufacturer Narrative · 1

    METHOD, RESULTS AND CONCLUSION: SIGNATURE SYSTEM WAS CHECKED BY FIELD SERVICE SPECIALIST ON (B)(4) 2013 AND HE PERFORMED SYSTEM SOFTWARE UPGRADE, PREVENTIVE MAINTENANCE, COMPLETED SERVICE CHECKLIST AND CALIBRATION TO MEET AMO SPECIFICATIONS. HE ALSO TESTED HANDPIECE FX ELLIPS SERIAL (B)(4) AND NO PROBLEM WAS FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING FIELDS OF INFORMATION THAT WERE SUBMITTED IN 2020664-2012-00093 SUPPLEMENTAL REPORT #3 ARE ACTUALLY CORRECTIONS: SIGNATURE SYSTEM WAS CHECKED BY FIELD SERVICE SPECIALIST ON (B)(4) 2013 AND HE PERFORMED SYSTEM SOFTWARE UPGRADE, PREVENTIVE MAINTENANCE, COMPLETED SERVICE CHECKLIST AND CALIBRATION TO MEET AMO SPECIFICATIONS. HE ALSO TESTED HANDPIECE FX ELLIPS SERIAL (B)(4) AND NO PROBLEM WAS FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL WILL BE SUBMITTED AS SOON AS ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CATARACT PROCEDURE PATIENT EXPERIENCED A CORNEAL BURN AT THE WOUND SITE. SIX SUTURES WERE NEEDED INDUCING ASTIGMATISM. DOCTOR REPORTED 6/120 POST OPERATIVE ONE DAY VISION DUE TO INDUCED ASTIGMATISM AND CORNEA WAS CLEAR. IT WAS ALSO REPORTED THAT THIS WAS THE SECOND TO THE LAST CASE OF THE DAY. THE CASES BEFORE AND AFTER WERE UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHITESTAR SIGNATURE¿ SYSTEM SIGNATURE HQC ABBOTT MEDICAL OPTICS NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ELLIPS HANDPIECE, SERIAL #(B)(4)