BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1616836 · Received February 16, 2010

    Report

    Report Number
    2023826-2010-00153
    Event Type
    Other
    Date Received
    February 16, 2010
    Date of Event
    June 2, 2009
    Report Date
    January 18, 2010
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) - OTHER, NO PRODUCT ALLEGATION - EVAL: RESULTS (OTHER): VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED A DRIED DARK RESIDUE, HOWEVER, THERE WAS NO VISIBLE DAMAGE TO THE LENS. (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN AQ21010V THREE PIECE SILICONE LENS AND IT WOULD NOT IN THE SULCUS. THE LENS WAS REMOVED AND AN ACL WAS IMPLANTED WITHOUT ANY PT INJURY. THE REPORTER STATED THE INCIDENT WAS DUE TO A PRE-EXISTING PT CONDITION.

    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. AQ2010V NA

    Patients

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