BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR FOAM TIP PLUNGER

    MDR report key: 1120011 · Received August 14, 2008

    Report

    Report Number
    2023826-2008-01061
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 23, 2008
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MSS
    PMA / PMN Number
    K980696
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT PERTAINING TO THIS COMPLAINT WAS NOT RETURNED, HOWEVER, THE LENS WAS RETURNED AND EVALUATED. A HAPTIC WAS TORN OFF AND THERE WAS CLEAR SURGICAL RESIDUE ON THE LENS. CONCLUSIONS: AN INVESTIGATION WAS OPENED TO EVALUATE A COMPLAINT TREND ASSOCIATED WITH LENS TEARS THAT WAS ORIGINALLY IDENTIFIED IN 2005. THE DAMAGE TO THE LENS, AS OBSERVED AND PHOTOGRAPHED UPON THE RETURN OF THE LENS TO STAAR, CANNOT BE DEFINITIVELY AND EXCLUSIVELY CORRELATED TO A SPECIFIC ROOT CAUSE. POSSIBLE ROOT CAUSES FOR LENS TEARS INCLUDE BOTH DELIVERY SYSTEM ISSUES AND POSSIBLE HANDLING ERRORS BY THE CUSTOMER. TO ADDRESS DELIVERY SYSTEM ISSUES, ALL STAGES IN THE MANUFACTURING OF THE INJECTORS AND CARTRIDGES WERE REVIEWED AND REVISED AS OPPORTUNITIES FOR IMPROVEMENT WERE REVEALED. TO ADDRESS HANDLING ERRORS, ALL INJECTOR/CARTRIDGE DIRECTIONS FOR USE (DFU) HAVE BEEN MODIFIED TO ADD FURTHER CLARIFICATIONS TO INSTRUCT THE USERS IN THE PROPER DELIVERY TECHNIQUES THAT ARE EFFECTIVE, AND MINIMIZE THE POTENTIAL FOR DAMAGING THE LENS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED A CC4204BF COLLAMER PLATE LENS AND THE FOAM TIP PLUNGER DID NOT SPREAD OPEN AND TORE THE LENS. THE LENS WAS REMOVED WITHOUT ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR FOAM TIP PLUNGER INTRAOCULAR LENS FOLDERS AND INJECTORS MSS STAAR SURGICAL COMPANY FOAM TIP PLUNGER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 LENS MODEL: CC4204BF| INJECTOR MODEL: UNKNOWN| CARTRIDGE MODEL: SFC-25 FP