BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2981650 · Received February 27, 2013

    Report

    Report Number
    2023826-2013-00155
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 29, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS WITH ASPHERIC. NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. TORN MATERIAL, SHARP EDGE. PRODUCT EVALUATION METHOD - LENS WORK ORDER SEARCH. RESULTS - VISUAL INSPECTION OF THE RETURNED LENS SHOWED LENS THE DEVICE WAS RETURNED IN LIQUID, BOTH HAPTICS WERE TORN OFF AND ONE HAPTIC HAD A SCRAPED MARK ON IT. NO SHARP EDGE WAS NOTED. A LENS WORK ORDER SEARCH WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOUND. CONCLUSION - (UNABLE TO CONFIRM): BASED ON THE COMPLAINT HISTORY, LENS WORK ORDER SEARCH AND PRODUCT EVALUATION, WE WERE UNABLE TO CONFIRM THIS REPORT. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED AFTER THE SURGEON INSERTED THE CC4204A COLLAMER SINGLE PIECE LENS IN THE EYE AND SHARP EDGE WAS NOTED. THE LENS WAS REMOVED WITHOUT ENLARGING THE INCISION AND ANOTHER SAME MODEL LENS WAS IMPLANTED. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83375 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR INDIGO-P INJECTOR MODEL, LOT NUMBER UNKNOWN| CARTRIDGE MODEL SFC25 FP, LOT NUMBER UNKNOWN| FTP INDIGO MODEL, LOT NUMBER UNKNOWN