BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 1760365 · Received July 18, 2010

    Report

    Report Number
    2648035-2010-00135
    Event Type
    Injury
    Date Received
    July 18, 2010
    Date of Event
    June 21, 2010
    Report Date
    July 1, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081/S032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IOL WAS NOT RECEIVED FOR ANALYSIS. THE CAUSE OF THIS EVENT REASONABLY SUGGESTS IT IS NOT MANUFACTURING RELATED BUT INSTEAD USER RELATED. THE IOL MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. AN UPDATE TO THIS REPORT WILL BE SUBMITTED IF LENS IS RECEIVED FOR ANALYSIS. DEVICE NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED INTRAOCULAR LENS (IOL) SHOWED THE DIOPTER MEASURED CORRECT AS LABELED, 12.0 D. THE INITIAL IMPLANT WAS REPLACED WITH A 15.5 DIOPTER LENS OF THE SAME MODEL. WHILE WE WERE UNABLE TO DETERMINE THE CAUSE OF THIS EVENT, OUR INVESTIGATION REASONABLY SUGGESTS IT IS NOT MANUFACTURING RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INTRAOCULAR LENS WAS EXPLANTED 3 DAYS AFTER THE INITIAL IMPLANT WITHOUT COMPLICATION. REASON STATED WAS THE WRONG DIOPTER WAS IMPLANTED AND WAS CHANGED TO A HIGHER POWER.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CLASSIFIED THIS COMPLAINT BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6), 2010 ALLEGING THAT THE ONETOUCH ULTRALINK METER IS GIVING INACCURATE ERRATIC READINGS OF "237 AND 85 MG/DL." THE PATIENT'S DIABETES IS MANAGED WITH AN INSULIN PUMP. ON (B)(6), 2010 AT 8:00 PM, THE PATIENT OBTAINED THE ALLEGED INACCURATE ERRATIC READINGS. AS A RESULT OF THE LFS METER READING, THE PATIENT ADMINISTERED SELF CARE WITH FOOD AND/OR DRINK. NO OTHER DEVICES WERE USED ON THE TIME OF CONCERN. THE PATIENT DID NOT HAVE ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS AS A RESULT OF THE PRODUCT ISSUE. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THERE WAS NO CONTROL SOLUTION TO PERFORM A QUALITY TEST. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS OF "237 AND 85 MG/DL" EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED INACCURATE ISSUE. THERE IS NO EVIDENCE THAT THE PATIENT SUFFERED A SERIOUS INJURY DUE TO THE PRODUCT ISSUE. THE PATIENT TOOK TREATMENT BASED ON THE LFS METER READINGS AND DID NOT HAVE ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS CL MONOFOCAL LENS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention