BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2895511 · Received January 3, 2013

    Report

    Report Number
    2023826-2013-00002
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 6, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED HALF OF THE LENS WAS TORN OFF AND MISSING AND 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). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAPTIC OF THE AQ2010V SILICONE THREE PIECE LENS, TORE AS THE SURGEON INSERTED IT IN THE EYE. THE LENS WAS REMOVED WITHOUT ANY PATIENT INJURY. THE REPORTER INDICATED THAT THE INCIDENT WAS THE RESULT OF A USER'S TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2168 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2010V N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR INJECTOR MODEL MSI-PM, LOT NUMBER UNKNOWN| AQ CARTIDGE-FP MODEL, LOT NUMBER UNKNOWN