BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISION ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 950660 · Received November 16, 2007

    Report

    Report Number
    2023826-2007-01927
    Event Type
    Other
    Date Received
    November 16, 2007
    Report Date
    October 17, 2007
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT A HAPTIC PLATE WAS TORN AND A PIECE OF IT WAS TORN OFF AND MISSING. THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED A MICL12.1 IMPLANTABLE COLLAMER LENS AND THE LENS WAS REMOVED. ADDITIONAL INFORMATION WAS REQUESTED BUT NON FORTHCOMING. IF ANY ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. THIS IS ONE OF TWO LENSES INSERTED IN THIS PT. SEE MFR REPORT# 2023826-2007-01928.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISION ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL CO. MICL 12.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR INJECTOR MODEL UNK| CARTRIDGE MODEL UNK