BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFICIENT PHACO NEEDLE

    MDR report key: 2211405 · Received August 8, 2011

    Report

    Report Number
    2020664-2011-00057
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K951462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHACO TIP WAS TESTED BY THE AMO PRODUCT SPECIALIST WHO CONFIRMED THE TIP WAS OCCLUDED; HOWEVER, THE PRODUCT SPECIALIST WAS ABLE TO FLUSH THE TIP AND CLEAR THE BLOCKAGE. THE TIP WAS TESTED ON A PHACO MACHINE AND PASSED PRIMING AND TUNING. THE PHACO TIP WAS RETURNED TO THE MFR AND EXAMINED FOR ANY UNUSUAL CONDITIONS THAT WOULD CAUSE BLOCKAGE DURING SURGERY. THE RESULTS OF THE INSPECTION REVEALED THAT THE TIP WAS CORRECTLY MACHINED AND THERE WAS NO EVIDENCE THAT ANY TITANIUM MATERIAL WAS BLOCKING THE TIP. THE CUSTOMER DECLINED TO PROVIDE FURTHER INFO ON THIS EVENT. ALL INFO THAT IS AVAILABLE HAS BEEN SUBMITTED, SHOULD ANY ADD'L INFO BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT A PT EXPERIENCED A CORNEAL BURN DURING A PHACOEMULSIFICATION (PHACO) PROCEDURE. THE PHACO TIP HAD OCCLUDED DURING THE PROCEDURE AND RESULTED IN THE BURN. THE PT EXPERIENCED WOUND LEAKAGE FOR A WEEK. IT IS UNK IF SUTURES WERE REQUIRED TO CLOSE THE INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFICIENT PHACO NEEDLE HQC ABBOTT MEDICAL OPTICS OPOR1521G 850498

    Patients

    Seq Age Sex Outcome Treatment
    1 Other