BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 6159876 · Received December 9, 2016

    Report

    Report Number
    2023826-2016-01746
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    September 21, 2016
    Report Date
    November 10, 2016
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    UDI-DI
    00841542103220
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER?: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS RETURNED IN AN SFC-45 FP CARTRIDGE. THERE WAS NO VISIBLE DAMAGE TO THE CARTRIDGE. THE WAS EVIDENCE OF CLEAR DRY RESIDUE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED. THE REPORTER STATED THE LENS WAS LOADED AND PREPARED FOR SURGERY BUT WAS NOT USED DUE TO PATIENT RELATED MEDICAL ISSUE. THERE WAS NO PATIENT CONTACT AND THE SURGERY HAD NOT BEGUN/ABORTED UNTIL A LATER DATE, WHEN ANOTHER ICL LENS WILL BE IMPLANTED. (B)(4).

    Description of Event or Problem · 1

    RECEIVED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -6.5 DIOPTER, FROM THE CUSTOMER STUCK INSIDE AN SFC-45 FP CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814173 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL13.2 NA 00841542103220

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK| FOAM TIP PLUNGER MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK