BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 4103541 · Received September 19, 2014

    Report

    Report Number
    2023826-2014-00736
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 25, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER MEDICAL REVIEW - REPORTEDLY, INTRAOPERATIVE LENS (3-PIECE COLLAMER) EXCHANGE WAS PERFORMED TO ADDRESS LENS DAMAGE DURING INSERTION. ANOTHER LENS OF THE SAME MODEL WAS IMPLANTED SUCCESSFULLY. INCISION WAS NOT ENLARGED AND NO OTHER TISSUE DAMAGE WAS REPORTED. ACCORDING TO THE REPORT FROM THE FACILITY DATED 9/16/2014, THE MOST LIKELY REASON OF THE EVENT WAS UNKNOWN. IT SHOULD BE NOTED THAT AT THE TIME OF THE SURGERY, THE PATIENT WAS (B)(6) YEARS OLD, AND PER FDA APPROVED DFU INDICATIONS: "THE COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE-PIECE FOLDABLE INTRAOCULAR LENSES ARE GENERALLY INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY CATARACT EXTRACTION." THEREFORE, THERE IS NO SUFFICIENT DATA TO SUPPORT IMPLANTATION IN SUCH PATIENTS. BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, PRODUCT EVALUATION, AND MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE FOLLOWING STATEMENT SHOULD HAVE BEEN ADDED IN SUPPLEMENTAL #2: DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE MANUFACTURING, INSPECTION, AND PACKAGING PROCESS CONCLUDED THERE WAS NOTHING FOUND TO SUGGEST A CONTRIBUTORY FACTOR TO THIS COMPLAINT. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THIS IS A RE-SUBMISSION OF MFR# 2023836-2014-00736 DUE TO PREVIOUS INCORRECT MFR#. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 1

    COLLAMER® ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT. FRACTURE, IOL. EVALUATION METHOD: WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND BOTH LOOP HAPTICS AND HALF OF THE LENS OPTIC IS TORN OFF AND MISSING. LENS WAS RETURNED IN LIQUID. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, POSSIBLE ROOT CAUSES FOR LENS TEARS INCLUDE BOTH DELIVERY SYSTEM ISSUES AND POSSIBLE HANDLING ERRORS BY THE CUSTOMER. A MULTIFUNCTIONAL TEAM INVESTIGATED COMPLAINTS REGARDING LENS TEARS ASSOCIATED WITH THE CQ CARTRIDGE: THE RESULTANT CORRECTIVE ACTIONS INCLUDED IMPROVEMENTS IN MANUFACTURING, RELEASE TESTING, AND EVALUATION OF TEST RESULTS. ADDITIONALLY, THE 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. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS IN PATIENT'S EYE. THE LENS WAS REMOVED DUE TO A TORN LENS. THERE WAS NO PATIENT INJURY. CAUSE OF LENS TEAR IS UNKNOWN. ANOTHER SAME MODEL, DIOPTER LENS WAS IMPLANTED. THE PHYSICIAN CUT THE LENS TO REMOVE IT. NO LOT NUMBERS FOR THE INJECTOR OR CARTRIDGE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583862 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR CARTRIDGE MODEL - CQ CARTRIDGE - LOT NUMBER - UNK