BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 2455411 · Received February 6, 2012

    Report

    Report Number
    2023826-2012-00097
    Event Type
    Malfunction
    Date Received
    February 6, 2012
    Date of Event
    December 27, 2011
    Report Date
    January 9, 2012
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULT: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE OPTIC IS TORN. BOTH LOOP HAPTICS ARE TORN OFF AND MISSING. LENS WAS RETURNED DRY. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSION: - BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, A LIKELY ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE DUE TO THE OFF-LABEL USE OF THE CARTRIDGE WITH THIS MODEL LENS.

    Description of Event or Problem · 1

    THE REPORTER STATED, THE SURGEON INSERTED A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS. THE LENS WAS REMOVED DUE TO LENS TEAR. THERE WAS NO PT INJURY. BACKUP LENS, SAME MODEL AND SIZE WAS IMPLANTED. THIS INCIDENT WAS DUE TO LOADING ERROR. THE SURGEON USED A COMPETITOR'S CARTRIDGE. THE CARTRIDGE USED HAS NOT BEEN APPROVED BY THE MFR FOR USED WITH THIS MODEL LENS. STATED THEY ARE AWARE THIS IS CONSIDERED OFF-LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1