BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 18430037 · Received January 2, 2024

    Report

    Report Number
    2023826-2024-00047
    Event Type
    Injury
    Date Received
    January 2, 2024
    Date of Event
    September 11, 2023
    Report Date
    December 5, 2023
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    UDI-DI
    00840311300600
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE REPORTER INDICATED THAT A 12.6MM VICM5 12.6 IMPLANTABLE COLLAMER LENS OF -10.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) AS A REPLACEMENT LENS ON (B)(6) 2023. REFRACTIVE SURPRISE WAS OBSERVED. THIS WAS DUE TO THE SURGEON IMPLANTING THE WRONG LENS INTO THE PATIENTS EYE. ANGLE BLOCK WITH ELEVATED IOP AND ANGLE CLOSURE WITH ELEVATED IOP WAS REPORTED DUE TO THE INITIAL LENS IMPLANT. ON (B)(6) 2023 THE LENS WAS REMOVED AND ON THE SAME DAY A REPLACEMENT LENS OF TORIC MODEL AND SAME SIZE WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. SEE MFR# 2023826-2024-00046 FOR INITIAL LENS. CLAIM# (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) AS A REPLACEMENT LENS ON 11-SEPT-2023. REPORTER STATES THE WRONG LENS WAS IMPLANTED. ON 13-SEPT-2023 REPORTER STATES THE "GOOD LENS IMPLANTED." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. SEE MFR# 2023826-2024-00046 FOR INITIAL LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156038 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICM5 12.6 NA 00840311300600
    479602 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICM5 12.6 NA 00840311300600

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male Required Intervention INJECTOR MODEL: MSI-TF, LOT# UNK