BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 3241107 · Received March 16, 2006

    Report

    Report Number
    2023826-2006-00303
    Event Type
    Malfunction
    Date Received
    March 16, 2006
    Date of Event
    February 8, 2006
    Report Date
    February 14, 2006
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT PART OF THE OPTIC AND ONE HAPTIC HAD BEEN TORN COMPLETELY OFF. THERE WAS EVIDENCE OF A CLEAR SURGICAL RESIDUE. CONCLUSION: (NO CONCLUSION CAN BE DRAWN). BASED ON THE COMPLAINT HISTORY AND EVAL OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN CQ2015 THREE PIECE COLLAMER LENS AND THE LENS TORE DURING INSERTION. THE LENS WAS REMOVED WITHOUT ENLARGING THE INCISION AND THERE WERE NO SUTURES REQUIRED. ANOTHER CQ2015 LENS WAS IMPLANTED. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. CQ2015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR INJECTOR: MODEL MSI-PM, LOT NUMBER UNK| CARTRIDGE: MODEL CQ CARTRIDGE-FP, LOT NUMBER UNK