BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1822116 · Received August 24, 2010

    Report

    Report Number
    2023826-2010-00834
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 29, 2010
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LENS INSERTED UPSIDE DOWN, UNLABELED. EVALUATION CONCLUSION: BASED ON THE COMPLAINT HISTORY, THE ROOT CAUSE OF THE EVENT IS A USER ERROR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY LOADING THE LENS AND THE MICL12.6 IMPLANTABLE COLLAMER LENS WAS INSERTED IN THE EYE UPSIDE DOWN. THE LENS TORE AS IT WAS REMOVED. THERE WAS NO PATIENT INJURY. THE REPORTER STATED THE INCIDENT WAS DUE TO A USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INJECTOR: MODEL MSI-PF, LOT NUMBER UNKNOWN| CARTRIDGE: MODEL SFC-45FP, LOT NUMBER UNKNOWN| FOAM TIP PLUNGER: MODEL, LOT NUMBER UNKNOWN