BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 17386315 · Received July 24, 2023

    Report

    Report Number
    2023826-2023-03116
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    July 13, 2023
    Report Date
    July 14, 2023
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: H6 - WORK ORDER SEARCH: NO SIMILAR COMPLAINT WAS REPORTED FOR UNITS WITHIN THE SAME LOT. CORRECTED DATA: A1: PATIENT IDENTIFIER: (B)(6). D2: COMMON DEVICE NAME: PHAKIC TORIC INTRAOCULAR LENS, PRODUCT CODE: QCB. CLAIM # (B)(4).

    Additional Manufacturer Narrative · 0

    A2: UNK. A3: UNK. A4: UNK. A5: UNK. A6: UNK. B3: UNK. D4: EXPIRATION DATE UNK. D6A: UNK. D6B:UNK. H4: UNK. CLAIM # (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED AN ICL IMPLANTABLE COLLAMER LENS, BROKE DURING LOADING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513994 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5_13.7 NA
    470619 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5_13.7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male CARTRIDGE MODEL SFC-45 - LOT # UNK| FOAM TIP PLUNGER MODEL FTP - LOT # UNK| INJECTOR MODEL MSI-PF - LOT # UNK