BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 17477732 · Received August 8, 2023

    Report

    Report Number
    2023826-2023-03353
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 11, 2023
    Report Date
    July 11, 2023
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 - TYPE OF INVESTIGATION - LENS WORK ORDER SEARCH: NO SIMILAR COMPLAINT TYPE EVENTS REPORTED FOR UNITS WITHIN THE SAME LOT. CLAIM# (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT A 13.7MM VTICM5_13.7 IMPLANTABLE COLLAMER LENS OF -12.50/2.5/030 WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) (B)(6) 2023. EXCESSIVE VAULT WAS OBSERVED, HOWEVER THE VAULT NORMALIZED AND THE PROBLEM RESOLVED. NO FURTHER INTERVENTION NEEDED. CUASE OF EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466053 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5_13.7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK| INJECTOR MODEL: MSI-PF, LOT# UNK