BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1359661 · Received March 3, 2009

    Report

    Report Number
    2023826-2009-00166
    Event Type
    Malfunction
    Date Received
    March 3, 2009
    Date of Event
    January 28, 2009
    Report Date
    February 2, 2009
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT A HAPTIC WAS TORN OFF AND PIECES OF THE OPTIC WERE TORN OFF AND MISSING. THERE WAS EVIDENCE OF A CLEAR SURGICAL RESIDUE. CONCLUSION: AN INVESTIGATION WAS OPENED TO EVALUATE A COMPLAINT TREND ASSOCIATED WITH LENS TEARS THAT WAS ORIGINALLY IDENTIFIED IN JUNE 2005. THE DAMAGE TO THE LENS, AS OBSERVED AND PHOTOGRAPHED UPON THE RETURN OF THE LENS TO STAAR, CAN NOT BE DEFINITIVELY AND EXCLUSIVELY CORRELATED TO A SPECIFIC ROOT CAUSE. POSSIBLE ROOT CAUSES FOR LENS TEARS INCLUDED: 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 SCRUB TECH HAD DIFFICULTY LOADING THE AQ2003V SILICONE THREE PIECE LENS AND THE HAPTIC TORE OFF, AS THE SURGEON INSERTED IT IN THE EYE. THE LENS WAS REMOVED WITHOUT ANY PT INJURY. THE REPORTER STATED THE INCIDENT WAS DUE TO A LOADING ERROR.

    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. AQ2003V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR CARTRIDGE: MODEL UNKNOWN| INJECTOR: MODEL UNKNOWN