BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1841492 · Received September 16, 2010

    Report

    Report Number
    2023826-2010-00930
    Event Type
    Malfunction
    Date Received
    September 16, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 19, 2010
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND LENS OPTIC TORN AND HAPTIC TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. (B)(4).

    Description of Event or Problem · 1

    THE RPTR STATED THE SURGEON INSERTED A CC4204A COLLAMER ASPHERIC SINGLE PLATE LENS. AFTER LENS WAS INSERTED, NOTICED LENS HAD TORN. LENS WAS REMOVED WITH NO PT INJURY. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED. THE RPTR STATED THE CAUSE OF THIS INCIDENT WAS DUE TO TECHNICAL ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 FOAM TIP PLUNGER - LOT NUMBER - UNK| INJECTOR MODEL - MSI-PF - LOT NUMBER - UNK| CARTRIDGE MODEL - SFC-25 FP - LOT NUMBER - UNK