BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHAKIC INTRAOCULAR LENS (ICL)

    MDR report key: 15070719 · Received July 20, 2022

    Report

    Report Number
    2023826-2022-02341
    Event Type
    Malfunction
    Date Received
    July 20, 2022
    Date of Event
    June 18, 2022
    Report Date
    June 20, 2022
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: LENS RETURNED IN A DEVICE TRAY. VISUAL INSPECTION FOUND FOREIGN MATERIAL ON /IN DEVICE. HAIR-LIKE FIBER STUCK BETWEEN THE LABEL STICKER AND TRAY. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    H6- METHOD CODE 3331: DEVICE HISTORY RECORD (DHR) REVIEW: BASED ON THE RESULTS OF THE INVESTIGATION, THE PROBABLE CAUSE OF THE FAILURE IS LIKELY DUE TO OPERATOR ERROR. TO HELP PREVENT FURTHER OCCURRENCES OF THIS TYPE OF ERROR, OPERATORS INVOLVED IN THE MANUFACTURING OF THIS NONCONFORMING DEVICE WILL BE RE-TRAINED AND MADE AWARE OF THE IMPORTANCE OF THAT THERE IS NO FOREIGN MATTER PRESENT IN THE PRODUCT TRAY. CLAIM# (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT A HAIR WAS MIXED IN THE PACKAGE OF SFC-45 SUPPER FUNNEL CARTRIDGE LOT # 1560627. IT WAS NOT USED ON THE PATIENT. ANOTHER SFC-45 WAS USED AND THE PROBLEM WAS RESOLVED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241362 PHAKIC INTRAOCULAR LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CARTRIDGE MODEL: SFC-45: LOT# UNK| FOAM TIP PLUNGER (FTP), LOT# 1560627| INJECTOR MODEL: MSI-PF, LOT# UNK