BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 14222057 · Received April 27, 2022

    Report

    Report Number
    2023826-2022-01278
    Event Type
    Injury
    Date Received
    April 27, 2022
    Date of Event
    December 17, 2021
    Report Date
    March 28, 2022
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNK. NA. THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4). WORK ORDER SEARCH: NO SIMILAR COMPLAINT WAS REPORTED FOR UNITS WITHIN THE SAME LOT. DEVICE HISTORY RECORD (DHR) REVIEW: BASED ON THE RESULTS OF THE INVESTIGATION, ALL RELEASED DEVICES FROM THE ASSOCIATED WORK ORDER(S), INCLUDING THE SUSPECTED DEVICE, HAVE BEEN MANUFACTURED WITHIN ESTABLISHED PROCESS PARAMETERS; AND THERE IS NO INDICATION THAT THE MANUFACTURING AND PROCESSING OF THE DEVICE CONTRIBUTED TO THE COMPLAINT ISSUE. CLAIM # (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H6- HEALTH IMPACT- CLINICAL CODE:4581- IRIS CONTRACTION. CLAIM# (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VICM5 12.6 IMPLANTABLE COLLAMER LENS, -03.00 DIOPTER, INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. THE REPORTER INDICATED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS OBSERVED AFTER LENS IMPLANTATION. DIAGNOSTICS WERE NOT PERFORMED. INTRAOCULAR RINSING AND REMOVAL OF FIBRIN WAS PERFORMED. THE PROBLEM WAS RESOLVED AND THE LENS REMAINED IMPLANTED. THERE WAS IRIS CONTRACTION. THE CAUSE OF THE EVENT WAS DUE TO USER ERROR (ALLERGIES TO LENSES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096573 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICM5_12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Required Intervention UNK.