BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3791386 · Received May 5, 2014

    Report

    Report Number
    2023826-2014-00329
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 14, 2014
    Report Date
    April 9, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS TORN INTO THREE (3) PIECES AND A PIECE OF THE OPTIC WAS TORN OFF AND MISSING. THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS.(B)(4).

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIMIDE). NO KNOWN CONSEQUENCES OR IMPACT TO THE PATIENT. TORN MATERIAL. EVALUATION CONCLUSION (NOT YET AVAILABLE EVALUATION IN PROGRESS): BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. A CURRENT INVESTIGATION INVOLVING CRACKED OPTICS ON THE SILICONE LENSES IS ONGOING. ONCE THE INVESTIGATION HAS CONCLUDED A SUPPLEMENTAL MEDWATCH FORM WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SURGEON HEARD A "POP" AS THE AQ2010V THREE PIECE SILICONE LENS WAS INSERTED AND NOTED THE OPTIC WAS CRACKED AFTER THE LENS WAS IN THE EYE. THE REPORTER STATED THE LENS SEEMS TO GET JAMMED ON THE RIGHT SIDE OF THE CARTRIDGE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER SAME MODEL LENS WITHOUT ANY HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267650 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 MSI-PM INJECTOR: MODEL, LOT NUMBER UNKNOWN| AQ CARTRIDGE-FP: MODEL, LOT NUMBER UNKNOWN