BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS

    MDR report key: 12840574 · Received November 18, 2021

    Report

    Report Number
    2023826-2021-04401
    Event Type
    Injury
    Date Received
    November 18, 2021
    Date of Event
    October 28, 2021
    Report Date
    November 3, 2021
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A 12.1MM VTICM5_12.1 LENS WAS IMPLANTED INTO THE PATIENT'S EYE ON (B)(6) 2021. ON (B)(6) 2021 THE LENS WAS EXPLANTED DUE TO LOW VAULT AND LENS ROTATION. ON (B)(6) 2021 A LONGER LENS WAS IMPLANTED. THE PROBLEM IS RESOLVED. THE CAUSE OF THE EVENT IS REPORTED AS UNKNOWN. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION: UNK. DATE OF REPORT: UNK. COMMON DEVICE NAME: PRODUCT CODE UNK. SERIAL NUMBER, IMPLANT DATE: UNK. DATE REC¿D BY MFR: PMA/510(K): THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. DEVICE MANUFACTURE DATE: UNK. CLAIM# (B)(4).

    Description of Event or Problem · 0

    HOLD FOR DD 2.11THE REPORTER STATED THAT THE SURGEON IMPLANTED AN IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS). THE SURGEON REPORTS LOW VAULT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737214 IMPLANTABLE COLLAMER LENS PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5_12.1 N/A
    1737220 IMPLANTABLE COLLAMER LENS PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5_12.1 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention CARTRIDGE MODEL-SFC-45, LOT#-UNK| FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK| INJECTOR MODEL-MSI-PF, LOT#-UNK