BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1923571 · Received December 2, 2010

    Report

    Report Number
    2023826-2010-01231
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 8, 2010
    Manufacturer
    STARR SURGICAL CO
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED A CLEAR SURGICAL RESIDUE ON THE LENS AND THERE WAS NO VISIBLE DAMAGE OBSERVED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED AS THE SURGEON THAT THE AQ2010V THREE PIECE SILICONE LENS WAS INSERTED AND REMOVED FROM THE EYE. A VITRECTOMY WAS PERFORMED, BUT THERE WAS NO DAMAGE TO THE CAPSULE. THE REPORTER STATED THE INCIDENT WAS DUE TO THE CONDITION OF THE PATIENT'S EYE AND NOT DUE TO THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STARR SURGICAL CO AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR MODEL UNK, LOT NUMBER UNK| CARTRIDGE MODEL AQ CARTRIDGE FP, LOT NUMBER UNK