BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H-10

    MDR report key: 2921104 · Received January 17, 2013

    Report

    Report Number
    2023826-2013-00055
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    October 2, 2012
    Report Date
    December 21, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS.(B)(4): EVALUATION:RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. THE LENS WAS RETURNED IN LIQUID. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS AND THE LENS WAS REMOVED DURING THE SAME SURGERY DUE TO A CAPSULE WEAKNESS/SUBCAPSULAR TEAR, WHICH POSSIBLY HAD OCCURRED PRIOR TO LENS INSERTION. THE SURGEON WAS AWARE OF THE CAPSULE TEAR AS HE CHOSE TO INSERT A THREE PIECE LENS, HE WAS AWARE THERE WAS A PROBLEM WITH THE CAPSULE BUT AFTER THE LENS WAS INSERTED, DECIDED THE LENS WAS NOT SUITABLE FOR THE PATIENT'S EYE, SO THE INCISION WAS ENLARGED TO REMOVE AND AN ANTERIOR CHAMBER LENS WAS IMPLANTED. SUTURES WERE REQUIRED TO CLOSE THE INCISION. AN ANTERIOR VITRECTOMY WAS PERFORMED. THE REPORTER STATED THE FACILITY USES A COMPETITOR'S PHACOEMULSIFICATION SYSTEM. THE REPORTER STATED THE EVENT WAS DUE TO A PATIENT PROBLEM/ISSUE AND WAS NOT LENS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26053 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention INJECTOR MODEL MSI-PM - LOT NUMBER UNK| CARTRIDGE MODEL CQ CARTRIDGE-FP - LOT NUMBER UNK