BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2082427 · Received May 10, 2011

    Report

    Report Number
    2023826-2011-00384
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 14, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIMIDE). (B)(4). LENS NOT RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN (B)(4) SILICONE THREE PIECE LENS BUT THE CAPSULE WOULD NOT SUPPORT THE POSTERIOR CHAMBER LENS DUE TO THE PATIENT BEING APHAKIC. THE LENS WAS REMOVED WITH NO PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE REPORTER STATED THE CAPSULE COULD NOT SUPPORT THE LENS DUE TO WEAK ZONULES AND THE PATIENT'S ANATOMY. AN ANTERIOR CHAMBER LENS WAS IMPLANTED. THE REPORTER STATED THEY USE A COMPETITOR'S PHACOEMULSIFICATION SYSTEM. THE REPORTER STATED THE LENS AND INJECTION SYSTEM DID NOT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2010V

    Patients

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