BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 2122112 · Received May 24, 2011

    Report

    Report Number
    2023826-2011-00444
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 28, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN (B)(4) THREE PIECE SILICONE LENS AND AFTER THE HAPTICS UNFOLDED, THE SURGEON DID NOT LIKE THE WAY THE LENS WAS POSITIONED IN THE EYE. THE LENS WAS REMOVED AND ANOTHER SAME MODEL LENS WAS IMPLANTED WITHOUT ANY PT INJURY. THE REPORTER STATED, THERE WAS NOT A PROBLEM WITH THE LENS BUT A SURGEON'S PREFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR CARTRIDGE: MODEL AQ CARTRIDGE-FP,| INJECTOR: MODEL MSI-TM, LOT NUMBER UNK| LOT NUMBER 1262098