BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1422951 · Received July 23, 2009

    Report

    Report Number
    2023826-2009-00803
    Event Type
    Other
    Date Received
    July 23, 2009
    Date of Event
    June 23, 2009
    Report Date
    June 24, 2009
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS: A VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND HALF OF THE LENS OPTIC AND ONE HAPTIC TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AND REMOVED A CC4204BF COLLAMER PLATE LENS. LENS WAS DAMAGED UPON INSERTION DUE TO LOADING ERROR. NO ENLARGED INCISION OR SUTURES REQUIRED. NO PT INJURY. THERE WERE THREE ATTEMPTS TO IMPLANT A LENS. THE FIRST TWO ATTEMPTS THE LENS WAS DAMAGED DUE TO LOADING ERRORS. ON THE THIRD ATTEMPT THE EYE CAPSULE WAS TOO WEAK TO HOLD LENS. ON THE FOURTH ATTEMPT A SULCUS LENS WAS IMPLANTED, NOT A STAAR LENS. SEE MFR REPORT# 2023826-2009-00804 AND 2023826-2009-00805.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL CO. CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR CARTRIDGE: MODEL SFC-25 FP| INJECTOR: MODEL INDIGO-P| FORM TIP PLUNGER: MODEL FTP INDIGO