BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 1760778 · Received July 19, 2010

    Report

    Report Number
    2648035-2010-00133
    Event Type
    Injury
    Date Received
    July 19, 2010
    Date of Event
    April 29, 2010
    Report Date
    June 29, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P99080/S06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND INSPECTED UNDER 10X MAGNIFICATION. RESULTS SHOWED ONE DISTORTED HAPTIC. IN FOLLOW-UP WITH THE ACCOUNT THE REPORTER STATED THE INTRAOCULAR LENS DID NOT CAUSE THE EVENT, PATIENT HAD A WEAK CAPSULAR BAG. WILL CONTINUE TO MONITOR AND TREND ALL REPORTS.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) HAS NOT BEEN RECEIVED FOR ANALYSIS. THE LENS MET ALL MANUFACTURING SPECIFIDATIIONS PRIOR TO RELEASE. AN UPDATE WILL BE SENT FOLLOWING RECEIPT AND ANALYSIS OF THE LENS. IOL NOT RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER ONETOUCH ULTRA2 METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE BEGAN ON (B)(6), 2010. THE PATIENT INFORMED THE CSR THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATIONS. DESPITE THE ALLEGED ISSUE, THE PATIENT DENIED MAKING ANY CHANGES TO HER USUAL DIABETES REGIMEN. ON THE AFTERNOON OF (B)(6), 2010, THE PATIENT CLAIMED SHE FELT DIZZY, VERY THIRSTY AND DEVELOPED A HEADACHE; SYMPTOMS SHE ASSOCIATED WITH A HIGH BLOOD GLUCOSE. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THAT THE PATIENT HAD REPLACED THE SUBJECT METER'S BATTERIES AS RECOMMENDED IN THE OWNER'S BOOKLET. THE ALLEGED POWER ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Description of Event or Problem · 1

    A NURSE REPORTED THE PATIENT'S POSTERIOR CAPSULAR BAG TORE AFTER IMPLANTATION OF THE INTRAOCULAR LENS(IOL). THE INCISION WAS ENLARGED, THE IOL REMOVED AND REPLACED WITH AN ALTERNATE LENS WITHOUT FURTHER COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MONOFOCAL LENS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention