BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2122340 · Received June 13, 2011

    Report

    Report Number
    2648035-2011-00110
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P99080/S06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: IN TELEPHONE FOLLOW-UP WITH THE SURGERY CENTER AND FOLLOWING REVIEW OF THE PATIENT FILE IT WAS CONFIRMED THE INCORRECT SERIAL NUMBER AND DIOPTER OF THE EXPLANTED LENS WERE INITIALLY REPORTED TO AMO. THE CORRECT SERIAL NUMBER IS (B)(6) AND NOT SERIAL NUMBER (B)(6) AS INITIALLY REPORTED TO THE MANUFACTURER. CORRECTIONS WERE MADE TO THE FOLLOWING FIELDS: NUMBER OF WEEKS IMPLANTED PRIOR TO EXPLANT. SERIAL # & EXPIRATION DATE. IMPLANTED DATE. DEVICE MANUFACTURE DATE. THE RETURNED IOL WAS MEASURED FOR DIOPTER AND WAS CORRECT AS LABELED, (B)(6). THE IOL MET ALL SPECIFICATIONS FOR OPTICAL PROPERTIES. A REVIEW OF THE IMPLANT DATABASE SHOWS THE LENS WAS EXCHANGED FOR A LOWER DIOPTER LENS OF THE SAME MODEL. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE RETURNED IOL HAS BEEN FORWARDED TO THE MANUFACTURING SITE FOR PRODUCT EVALUATION. ALL INFORMATION AVAILABLE IS INCLUDED IN THIS REPORT. DEVICE SENT TO MFG. SITE FOR EVALUATION.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THAT THE LENS WAS EXPLANTED TEN DAYS AFTER IMPLANT DUE TO IMPROPER INTRAOCULAR LENS POWER. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    THE LENS WAS EXPLANTED 3 WEEKS AFTER IMPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention