BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 2810015 · Received October 23, 2012

    Report

    Report Number
    2023826-2012-00826
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 25, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULT - A VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE LOOP HAPTIC IS BENT AND OPTIC IS TORN. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSION - AN INVESTIGATION OF THE ROOT CAUSES OF LENS TEARS, SIMILAR TO THAT STATED IN THIS CLAIM, WERE ADDRESSED IN A CAPA OPENED IN 06/2005 (WHICH WAS SUBSEQUENTLY CLOSED). THE CAPA ADDRESSED DELIVERY SYSTEM ISSUES INCLUDING ALL STAGES OF MFG OF THE INJECTORS AND CARTRIDGES. PROCESSES WERE REVIEWED AND REVISED. THE CAPA ALSO ADDRESSED 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. BASED ON THE COMPLAINT HISTORY AND THE EVAL OF THE RETURNED PRODUCT, POSSIBLE ROOT CAUSES FOR LENS TEARS 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 AN AQ2010V THREE PIECE SILICONE LENS. LOOP HAPTIC BENT DURING INSERTION IN THE PT'S LEFT EYE. THE SURGEON DID NOT ENLARGED THE INCISION TO REMOVE THE LENS, BUT SUTURE WAS USED. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED. NO LOT NUMBERS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention INJECTOR: MODEL - MSI-TM, LOT # UNK| CARTRIDGE: MODEL - AQ CARTRIDGE-FP, LOT # UNK