BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H-10

    MDR report key: 2063533 · Received April 19, 2011

    Report

    Report Number
    2023826-2011-00339
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 28, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4) - SURGICAL INCISION, ENLARGEMENT OF, SURGICAL PROCEDURE, LENS SUTURED INTO EYE. (B)(4) - LENS (IOL), TORN, SPLIT, CRACKED. EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN. A PIECE OF THE LENS OPTIC AND BOTH HAPTICS WERE TORN OFF AND MISSING. 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 BUT THE WRONG INJECTION SYSTEM WAS USED IN ERROR AND THE LENS TORE. THE REPORTER STATED THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER SAME MODEL LENS WAS USED WITH THE CORRECT INJECTION SYSTEM BUT THAT LENS ALSO TORE. A PMMA LENS WAS IMPLANTED AND WAS SUTURED INTO THE EYE. THE REPORTER STATED THE CQ2015A WAS A NEW LENS FOR THE SURGEON AND HE WAS UNFAMILIAR WITH IT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INJECTOR: MODEL AND LOT NUMBER UNK| CARTRIDGE: MODEL AND LOT NUMBER UNK