BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLO IA TIP, STRAIGHT, .3MM

    MDR report key: 3251086 · Received July 29, 2013

    Report

    Report Number
    2020664-2013-00062
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCOUNT REPORTED TO SALES REPRESENTATIVE (SR) THAT THEY WERE USING AN AUTOMATIC SURGICAL INSTRUMENT CLEANING MACHINE MADE BY (B)(4) TO PERFORM ULTRASONIC CLEANING OF I/A HANDPIECE AND THE MACHINE USES DETERGENTS AND ANTI-CORROSIVE AGENTS. THIS IS CONTRARY TO THE INSTRUCTIONS FOUND IN THE DIRECTIONS FOR USE PROVIDED WITH THE PRODUCT. THE CUSTOMER THOUGHT THESE SUBSTANCES MAY RESIDE WITHIN THE CANNULA. UPON REVIEWING THE CLEANING PROCEDURE DIRECTIONS FOR USE (DFU) AFTER THE INCIDENTS, THE CUSTOMER HAS DECIDED TO CLEAN THEM WITHOUT ADDING DETERGENTS AND ANTI-CORROSIVE AGENTS. ON A LATER VISIT THE ACCOUNT REPORTED TO SR THAT THEY HANDPIECES ARE CLEANED FOLLOWING THE DFU; ULTRASONIC CLEANING WAS NOT USED.

    Additional Manufacturer Narrative · 1

    PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    INVESTIGATION FROM MANUFACTURER: THE DAMAGE TO THE PORTS COULD HAVE BEEN CAUSED BY THE CUSTOMER TRYING TO REMOVE THE RESIDUE WITH ANOTHER INSTRUMENT AS IT WAS REPORTED TO US BY THE SALES REPRESENTATIVE (SR); CUSTOMER TRIED TO REMOVE CLOG WITH A LENS HOOK AND CLEAN THE TIP. (WORD TIP WAS MISSING FROM SENTENCE.) (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ACCOUNT REPORTED THAT SYMPTOMATIC STATES WERE SUBSIDED BY PRESCRIBING STEROID. THEY ALSO SAID THAT CAUSE OF THE INCIDENTS COULD NOT BE IDENTIFIED; ALTHOUGH, SURGEON SPECULATES THAT ONE OF THE PROBABLE CAUSES COULD BE DENATURIZING OF THE OPTHALMIC VISCOELASTIC DEVICE (OPEGAN HI AND VISCOAT) RESIDED WITHIN IRRIGATION/ASPIRATION HANDPIECE DUE TO INSUFFICIENT CLEANING. THERE ARE FIVE IA HANDPIECES AT THE CUSTOMER SITE THAT ARE REUSED AFTER STERILIZING. ACCOUNT REPORTED TO SALES REPRESENTATIVE (SR) THAT THEY WERE USING AN AUTOMATIC SURGICAL INSTRUMENT CLEANING MACHINE MADE BY SHARP TO PERFORM ULTRASONIC CLEANING OF I/A HANDPIECE AND THE MACHINE USES DETERGENTS AND ANTI-CORROSIVE AGENTS. THE CUSTOMER THOUGHT THESE SUBSTANCES MAY RESIDE WITHIN THE CANNULA. UPON REVIEWING THE CLEANING PROCEDURE DIRECTIONS FOR USE (DFU) AFTER THE INCIDENTS, THE CUSTOMER HAS DECIDED TO CLEAN THEM WITHOUT ADDING DETERGENTS AND ANTI-CORROSIVE AGENTS. ON A LATER VISIT THE ACCOUNT REPORTED TO SR THAT THEY HANDPIECES ARE CLEANED FOLLOWING THE DFU; ULTRASONIC CLEANING WAS NOT USED. INVESTIGATION FROM MANUFACTURER: ALL 5 OF THE RETURNED UNITS HAVE RESIDUE EITHER AROUND OR INSIDE THE PORT AREA, THIS RESIDUE IS MOST LIKELY DRIED VISCOELASTIC. ALSO, ALL 5 OF THE PORTS ON THE RETURNED UNITS ARE DAMAGED TO SOME DEGREE. THE DAMAGE TO THE PORTS COULD HAVE BEEN CAUSED BY THE CUSTOMER TRYING TO REMOVE THE RESIDUE WITH ANOTHER INSTRUMENT AS IT WAS REPORTED TO US BY THE SALES REPRESENTATIVE (SR); CUSTOMER TRIED TO REMOVE CLOG WITH A LENS HOOK AND CLEANED THE . RETURNED UNITS WOULD NOT HAVE SHIPPED IN THIS CONDITION. OTHER SIGNS OF WEAR AND TEAR ARE CONSISTENT WITH UNITS THAT ARE ALMOST 3 YEARS OLD. WITH THE RESIDUE PRESENT AND DAMAGE TO THE PORTS ALONG WITH THE CUSTOMER STATEMENT SHOWING THEIR CLEANING METHODS ARE NOT PER THE RECOMMENDED PROCEDURE WE WILL BE CLOSING THIS COMPLAINT AS A CUSTOMER MAINTENANCE ISSUE.

    Description of Event or Problem · 1

    ONE DAY POST OPERATION, THE SYMPTOMATIC STATES OF TASS (TOXIC ANTERIOR SEGMENT SYNDROME) WERE OBSERVED. NO HISTORY OF PREVIOUS ILLNESS OR NO COMPLICATING DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353714 SOLO IA TIP, STRAIGHT, .3MM PHACO ACCESSORY HQC ABBOTT MEDICAL OPTICS OPO1A20STR

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR OPEGAN HI AND VISCOAT