BEUDAMED
    FDA Adverse Event Injury Summary report: N

    23GA COMBINED WIDE-FIELD ELITE PACK

    MDR report key: 11739692 · Received April 28, 2021

    Report

    Report Number
    0001920664-2021-00050
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    April 9, 2021
    Report Date
    April 9, 2021
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    UDI-DI
    00757770059959
    PMA / PMN Number
    K170052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THERE IS A NC/CAPA 941845 OPENED FOR THIS TYPE OF COMPLAINT. THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND STERILIZATION RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THREE ESA HUB AND SLEEVE ASSEMBLIES, AND PART OF AN INFUSION LINE WERE RETURNED INSIDE OF A TEST CHAMBER THAT HAD A CASSETTE PLUG INSERTED IN THE BACK (MAKE SHIFT STOPPER). THE TEST CHAMBER AND OTHER COMPONENTS WERE INSIDE OF AN OPENED SMALL PARTS POUCH. THE ASSEMBLIES WERE DIRTY. THE RETURNED SECTION OF THE INFUSION LINE WAS INSERTED INTO ONE ESA HUB AND SLEEVE ASSEMBLY. THE ESA HUB AND SLEEVE ASSEMBLY WERE REMOVED FROM THE INFUSION LINE FOR INSPECTION. MICROSCOPIC EXAMINATION FOUND THE ESA HUB AND SLEEVE ASSEMBLY THAT WERE RECEIVED ATTACHED TO THE INFUSION LINE HAD A GAP BETWEEN THE FLAPS ON THE VALVE. ONE OF THE OTHER TWO ASSEMBLIES HAD OFF CENTER SLITS IN THE VALVE. THE THIRD ASSEMBLY HAD NO VISIBLE DAMAGE, THE SLITS WERE CENTER AND THERE WERE NO GAPS. IT SHOULD BE NOTED THAT A GAP BETWEEN THE FLAPS OF THE VALVE COULD CONTRIBUTE TO LEAKING. HOWEVER, DUE TO THE RETURNED CONDITION, A CAUSE FOR THE GAPS IN THE FLAPS COULD NOT BE DETERMINED. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. A CAPA IS CURRENTLY OPEN FOR MONITORING COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ONGOING.

    Description of Event or Problem · 1

    THE USER FACILITY IN THE (B)(4) OBSERVED DURING SURGERY FOLLOWING THE INITIAL TROCAR INSERTION, THE EYE BECAME SOFT DUE TO THE TROCAR LEAKING. THE TROCAR APPEARED TO BE INSERTED WITH THE CORRECT TECHNIQUE. INFUSION LINE WAS CONNECTED TO RE-PRESSURIZE THE EYE AND PLACE TWO OTHER TROCARS, BUT THE TROCARS CONTINUED TO LEAK DURING THE CASE. THE PATIENT WAS NOT ADVERSELY AFFECTED, AND NO ADDITIONAL TREATMENT WAS REQUIRED. THE INFUSION PRESSURE WAS 35MMHG DURING THE OBSERVED LEAKING. THIS OCCURRED DURING A GENE THERAPY CASE WHICH SHOULD HAVE INCLUDED A DRY SAMPLE OF VITREOUS BEFORE APPLYING INFUSION, BUT THIS COULD NOT OCCUR DUE TO THE EYE BEING TOO SOFT TO INSERT A SECOND TROCAR FOR THE SAMPLE. THEREFORE, NO PATIENT IMPACT, BUT CAUSED A DEVIATION FROM A STRICT PROTOCOL. THE PATIENT WILL NOT UNDERGO AN ADDITIONAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635633 23GA COMBINED WIDE-FIELD ELITE PACK UNIT PHACOFRAGMENTATION HQC BAUSCH + LOMB SE5523WV 222 00757770059959

    Patients

    Seq Age Sex Outcome Treatment
    1 STELLARIS UNIT.| STELLARIS UNIT.| STELLARIS UNIT.