BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1220522 · Received October 29, 2008

    Report

    Report Number
    2023826-2008-01335
    Event Type
    Other
    Date Received
    October 29, 2008
    Date of Event
    July 11, 2008
    Report Date
    October 2, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER, NO COMPLAINT AGAINST THE LENS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED A CC4204BF COLLAMER PLATE LENS AND DID NOT LIKE THE WAY THE LENS SEATED IN THE EYE. THE LENS WAS REMOVED AND A DIFFERENT TYPE OF LENS WAS IMPLANTED WITHOUT ANY PATIENT INJURY. THE REPORTER STATED THERE WAS NOT A PROBLEM WITH THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE INTRAOCULAR LENS HQL STAAR SURGICAL CO. CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR CARTRIDGE: MODEL SFC-25FP| INJECTOR: MODEL INDIGO-P| FTP INDIGO MODEL