BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1841275 · Received September 15, 2010

    Report

    Report Number
    2023826-2010-00913
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 18, 2010
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED A HAPTIC WAS TORN OFF AND MISSING AND THERE WERE TEARS IN THE OPTIC. THERE WAS EVIDENCE OF A CLEAR SURGICAL RESIDUE. CONCLUSION: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAPTIC OF A CC4204A COLLAMER PLATE LENS TORE AS THE LENS WAS INSERTED. THE LENS WAS REMOVED WITHOUT ANY PATIENT INJURY AND ANOTHER SAME MODEL LENS WAS IMPLANTED.

    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 COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR NANOPOINT INJECTOR: MODEL, LOT NUMBER UNKNOWN| NANOPOINT CARTRIDGE: MODEL, LOT NUMBER UNKNOWN