BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILCONE COATED I/A 45 HANDHELD INSTRUMENT

    MDR report key: 8586241 · Received May 7, 2019

    Report

    Report Number
    0001920664-2019-00084
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    April 4, 2019
    Report Date
    April 16, 2019
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    PMA / PMN Number
    K073023
    Removal / Correction Number
    G5
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED FROM EXEMPT TO K073023. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE MOST PROBABLE ROOT CAUSE IS USER ERROR. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO FURTHER INVESTIGATION OR CORRECTIVE ACTION IS NECESSARY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED THE HANDPIECE TORE THE CAPSULE WITHOUT VITREOUS LOSS AND THE HYALOID PRESERVED. THE INCISION SIZE WAS 2.2MM.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED, NO DEVIATION OR ISSUE WAS DETECTED. THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED THE IRRIGATION/ASPIRATION SINGLE USE HANDPIECE PRESENTED WITH SHARP IRRIGATION PORTS. THE HANDPIECE TORE THE CAPSULE. CONSEQUENTLY, THE PATIENT NEEDED A SULCUS LENS IMPLANT. A REPLACEMENT PRODUCT WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379321 SILCONE COATED I/A 45 HANDHELD INSTRUMENT UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB 85795ST FS19025220

    Patients

    Seq Age Sex Outcome Treatment
    1