BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 3070290 · Received April 16, 2013

    Report

    Report Number
    2023826-2013-00291
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 19, 2013
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD - LENS WORK ORDER SEARCH MEDICAL REVIEW. RESULT - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. MEDICAL REVIEW - REVIEW OF THIS FILE INDICATES THAT THE SURGEON PERFORMED EXTRACAPSULAR CATARACT EXTRACTION AND COULD NOT EFFECTIVELY IMPLANT THE HAPTICS OF THIS LENS IN THE BAG AT THE INFERIOR PORTION. ANOTHER LENS WITH SAME MODEL AND DIOPTER WAS ATTEMPTED TO BE IMPLANTED WITH THE SAME PROBLEM. THE SURGEON THINKS THAT THE IOL HAPTICS HAD LOST IT'S ELASTICITY. AN ANTERIOR CHAMBER LENS WAS IMPLANTED PRIOR TO WOUND CLOSURE. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS CASE. CONCLUSIONS - NO CONCLUSION CAN BE DRAWN. THE PRODUCT PERTAINING TO THIS EVENT WAS DISCARDED. BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED HE INSERTED A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS INTO THE PT'S RIGHT EYE. THE SECOND LOOP WOULD NOT STAY IN THE POSTERIOR CAPSULAR BAG, INFERIORLY AS THROUGH IT HAD LOST ITS ELASTICITY. THIS WAS ATTEMPTED THREE TIMES WITH EACH LENS BUT THE INFERIOR LOOP CONTINUED TO PROLAPSE INTO THE ANTERIOR CHAMBER, ANTERIOR TO THE IRIS. THE LENS WAS REMOVED AND DISCARDED. THERE WERE TWO LENSES USED IN THIS INCIDENT WITH THE SAME RESULTS. A THIRD LENS, AN ANTERIOR CHAMBER LENS WAS IMPLANTED. A SUTURE WAS USED TO CLOSE THE WOUND. SEE MFR #2023826-2013-00292 FOR THE SECOND LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163767 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR CARTRIDGE: MODEL UNK, LOT UNK| INJECTOR: MODEL UNK, LOT UNK