BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISERT 231

    MDR report key: 5233948 · Received November 18, 2015

    Report

    Report Number
    3006723646-2015-00431
    Event Type
    Injury
    Date Received
    November 18, 2015
    Date of Event
    April 13, 2015
    Report Date
    July 23, 2015
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL MDR STATED: MANUFACTURER REQUESTED ADDITIONAL INFORMATION FROM THE DOCTOR'S OFFICE ON THE PATIENT'S CONDITION. AS OF (B)(6) 2015, PATIENT'S PROGNOSIS WAS NOTED AS "RESOLVED AS OF (B)(6) 2015. UNCORRECTED VISION 20/20-." LENS WAS NOT EXPLANTED AFTER PATIENT EXPERIENCED POSTOPERATIVE ENDOPHTHALMITIS. ANALYSIS SHALL CONSIST OF DEVICE HISTORY REVIEW TO VERIFY REQUIREMENTS WERE MET AND ENSURE NO NON-CONFORMANCES WERE DETECTED DURING MANUFACTURE OF PRODUCT. A SUPPLEMENTAL REPORT WILL BE FILED WITH FDA AFTER THESE INVESTIGATIONS ARE CONCLUDED. THE PURPOSE OF THIS FOLLOW UP REPORT IS TO PROVIDE THE FOLLOWING ADDITIONAL INFORMATION: A POSTOPERATIVE INFLAMMATION SUMMARY (POIS) REPORT WAS PROVIDED BY (B)(6), WHERE DR. (B)(6) PERFORMED THE PROCEDURE. THE FORM WITH THE REQUESTED INFORMATION WAS MAILED TO HOYA AND RECEIVED ON 11-AUG-2015. A REVIEW OF THE INFLAMMATION COMPLAINT, INCLUDING THE POIS FORM, WAS PERFORMED BY (B)(4), MEDICAL DEVICE CONSULTANT FOR HOYA SURGICAL OPTICS, INC. MS. (B)(4) REVIEW CONCLUDED THAT, "THE HIGH INCIDENCE OF ENDOPHTHALMITIS EXPERIENCED BY DR. KOHLER CANNOT BE EXPLAINED BASED ON THE INFORMATION AVAILABLE TO HOYA. IT IS, HOWEVER, BELIEVED TO BE UNRELATED TO THE HOYA LENSES, WHICH WERE STERILE AS SUPPLIED AND THERE HAVE BEEN NO CHANGES TO THE LENS MATERIAL OR THE MANUFACTURING PROCESS OF THE LENSES BASED ON HOYA'S INTERNAL INVESTIGATION. FURTHER, THE INCIDENCE OF ENDOPHTHALMITIS AFTER IMPLANTATION OF HOYA LENSES IN THE U.S. FOR THE PAST THREE YEARS IS 0.017%, WHICH IS VERY LOW." INTRAOCULAR LENS WAS NOT EXPLANTED.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REQUESTED ADDITIONAL INFORMATION FROM THE DOCTOR'S OFFICE ON THE PATIENT'S CONDITION. AS OF (B)(6) 2015, PATIENT'S PROGNOSIS WAS NOTED AS "RESOLVED AS OF (B)(6) 2015. UNCORRECTED VISION 20/20-." LENS WAS NOT EXPLANTED AFTER PATIENT EXPERIENCED POSTOPERATIVE ENDOPHTHALMITIS. ANALYSIS SHALL CONSIST OF DEVICE HISTORY REVIEW TO VERIFY REQUIREMENTS WERE MET AND ENSURE NO NON-CONFORMANCES WERE DETECTED DURING MANUFACTURE OF PRODUCT. A SUPPLEMENTAL REPORT WILL BE FILED WITH FDA AFTER THESE INVESTIGATIONS ARE CONCLUDED. INTRAOCULAR LENS WAS NOT EXPLANTED.

    Description of Event or Problem · 1

    DATE OF INTRAOCULAR LENS IMPLANT OCCURRED (B)(6) 2015. PATIENT EXPERIENCED EYE INFLAMMATION THREE DAYS AFTER SURGERY. INTRAOCULAR LENS WAS NOT EXPLANTED. PATIENT RECEIVED TREATMENT FOR POSTOPERATIVE ENDOPHTHALMITIS. THIS EVENT IS BEING REPORTED AT THE TIME COMPANY BECAME AWARE, WHICH WAS ON JULY 23, 2015, VIA COMPANY'S SALES REPRESENTATIVE WHO WAS NOTIFIED BY OPHTHALMIC SURGEON.

    Description of Event or Problem · 1

    DATE OF INTRAOCULAR LENS IMPLANT OCCURRED (B)(6) 2015. PATIENT EXPERIENCED EYE INFLAMMATION THREE DAYS AFTER SURGERY. INTRAOCULAR LENS WAS NOT EXPLANTED. PATIENT RECEIVED TREATMENT FOR POSTOPERATIVE ENDOPHTHALMITIS. THIS EVENT IS BEING REPORTED AT THE TIME COMPANY BECAME AWARE, WHICH WAS ON (B)(6) 2015, VIA COMPANY'S SALES REPRESENTATIVE WHO WAS NOTIFIED BY OPHTHALMIC SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762064 ISERT 231 INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. 231 AK008

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention