BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING CHAMBER SIBGLE FOLDABLE INTRAOCULAR LENS (ELASTIC

    MDR report key: 3802397 · Received February 21, 2014

    Report

    Report Number
    2023826-2014-00136
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 24, 2014
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: LENS WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND HALF OF THE LENS IS TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE SAME WORK ORDER. CONCLUSION: AN INVESTIGATION OF THE ROOT CAUSES OF LENS TEARS, SIMILAR TO THAT STATED IN THIS CLAIM WAS PERFORMED. THE INVESTIGATION ADDRESSED DELIVERY SYSTEM ISSUES INCLUDING ALL STAGED OF MANUFACTURING OF THE INJECTORS AND CARTRIDGES. PROCESSES WERE REVIEWED AND REVISED AS OPPORTUNITIES FOR IMPROVEMENT WERE REVEALED. THE INVESTIGATION ALSO ADDRESSED HANDLING ERRORS. ALL INJECTORS/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. BASED ON THE COMPLAINT HISTORY AND THE EVAL OF THE RETURNED PRODUCT, POSSIBLE ROOT CAUSES FOR LENS INCLUDE BOTH DELIVERY SYSTEM ISSUES AND HANDLING ERRORS BY THE CUSTOMER #(B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A AA4203TL SILICONE SINGLE PIECE LENS WITH TORIC OPTIC INTO THE PATIENT'S LEFT EYE. IT WAS NOT NOTED UNTIL THE PHYSICIAN STARTED ADVANCING THE LENS INTO THE PATIENT'S EYE, THAT A PART OF THE PLUNGER ON THE INJECTOR WAS MISSING. AFTER LENS INSERTION NOTICED THERE WAS A PIECE OF THE LENS MISSING. THE LENS WAS REMOVED. THERE WAS NO PT INJURY. A BACKUP LENS WAS IMPLANTED, SAME MODEL AND SIZE. THE CARTRIDGE AND INJECTOR WERE DISCARDED. NO LOT NUMBERS ARE AVAILABLE. UNK HOW MANY TIMED THE INJECTOR WAS USED PRIOR TO THIS INCIDENT. CAUSE OF THIS INCIDENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110323 SILICONE ULTRAVIOLET-ABSORBING CHAMBER SIBGLE FOLDABLE INTRAOCULAR LENS (ELASTIC INTRAOCULAR LENS HQL STAAR SURGICAL CO. AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR MODEL: MSI-PR, LOT#:UNK| CARTRIDGE MODEL: MTC-60C FP, LOT#:UNK