BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 2113837 · Received May 17, 2011

    Report

    Report Number
    2023826-2011-00413
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 20, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED AFTER THE SURGEON INSERTED THE (B)(4) SILICONE PLATE LENS, THE SURGEON DISCOVERED THE 2.0 DIOPTER WAS TOO MUCH FOR THE PT. THE LENS WAS REMOVED IMMEDIATELY AND A SMALLER DIOPTER LENS WAS IMPLANTED. THERE WAS NO PT INJURY. THE REPORTER STATED THE INCIDENT WAS THE RESULT OF WRONG DIOPTER SELECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE: MODEL MTC-60CFP, LOT NUMBER UNK| INJECTOR: MODEL MSI-TR, LOT NUMBER UNK