BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 2440723 · Received January 31, 2012

    Report

    Report Number
    2023826-2012-00070
    Event Type
    Injury
    Date Received
    January 31, 2012
    Date of Event
    January 17, 2012
    Report Date
    January 20, 2012
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND LOOP HAPTIC AND PIECE OF OPTIC STUCK INSIDE CARTRIDGE. NO VISIBLE DAMAGE TO CARTRIDGE. 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 JUNE 2005 (WHICH WAS SUBSEQUENTLY CLOSED). THE CAPA ADDRESSED DELIVERY SYSTEM ISSUES INCLUDING ALL STAGES OF MANUFACTURING OF THE INJECTORS AND CARTRIDGES. PROCESSES WERE REVIEWED AND REVISED AS OPPORTUNITIES FOR IMPROVEMENT WERE REVEALED. THE CAPA ALSO ADDRESSED HANDLING ERRORS. ALL INJECTOR/CARTRIDGE DIRECTIONS FOR USE (DFU) HAVE BEEN MODIFIED TO ADD FURTHER CLARIFICATION 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 EVALUATION 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 AQ2015A SILICONE ASPHERIC THREE PIECE LENS. THE TRAILING HAPTIC BROKE OFF WHILE INSERTING INTO THE EYE. LENS WAS REMOVED, NO ENLARGED INCISION. BACKUP LENS, SAME MODEL AND SIZE WAS IMPLANTED AND ONE SUTURE USED TO CLOSE THE WOUND.

    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 CO. AQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INJECTOR: MODEL MSI-TM, LOT NUMBER UNKNOWN| CARTRIDGE: MODEL AQ CARTRIDGE-FP, LOT NUMBER UNK| VISCOELASTIC: STAARVISC II, LOT NUMBER UNKNOWN