BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIFLEX

    MDR report key: 16828089 · Received April 27, 2023

    Report

    Report Number
    3012236936-2023-00987
    Event Type
    Injury
    Date Received
    April 27, 2023
    Report Date
    December 22, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474501461
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES . SECTION D9: RETURNED TO MANUFACTURER ON: SEPTEMBER 7, 2023. SECTION H3: DEVICE EVALUATED BY MANUFACTURER¿ YES. DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED WRAPPED IN GAUZE. PRODUCT EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THE LENS WAS RECEIVED COVERED IN A TRANSPARENT SUBSTANCE. A WHITE SUBSTANCE IS ALSO OBSERVED TOWARDS THE CENTER OF THE LENS OPTIC CONSISTENT WITH THE COMPLAINT ISSUE. HAPTIC DAMAGE IS ALSO OBSERVED. BASED ON THE FTIR RESULTS IT WAS CONCLUDED THAT THE LENS SHOULD BE CLEANED AND VISUAL INSPECTION PERFORMED. BROWN SPECS COULD BE OBSERVED INSIDE OF THE LENS MATERIAL. SUBJECT MATTER EXPERT (SME) EVALUATION: THE SME EVALUATION CONCLUDED THAT THE MARKINGS IN THE LENS ARE CONSISTENT WITH A YAG LASER TREATMENT. THEREFORE, NO FURTHER EVALUATION CAN BE PERFORMED. A MATERIAL ANALYSIS REPORT WAS REQUESTED FOR THE FOREIGN MATERIAL. PER THE ANALYSIS, THE BULK OF THE PLASTIC MATERIAL IS A MIXTURE, POSSIBLY COMPOSED OF SOME OR ALL OF THE FOLLOWING: POLYETHYLENE GLYCOL (PEG) OLEATE, ANOTHER GLYCOL DERIVATIVE SUCH AS PEG ETHER/ESTER, POSSIBLY A GLYCOL TALLOWATE (WAXY SOAP), AND OTHER UNIDENTIFIED SPECIES. THE FTIR SPECTRUM RAW DATA OUTPUT FILE GENERATED WAS THEN COMPARED AGAINST THE MANUFACTURING PROCESS FTIR LIBRARY AND DID NOT YIELD ANY RESULTS WITH AT LEAST A 0.90000 CORRELATION. THE TOP HIT WAS ¿THERMAL TRANSFER RIBBON - MATTE SIDE¿ WITH A 0.4940037 CORRELATION. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D6B: IF EXPLANTED; GIVE DATE: EXACT DATE UNKNOWN, ESTIMATED TO BE IN (B)(6) 2023. SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE DUE TO BLURRY VISION AS A RESULT OF THE IOL BEING CLOUDY. THE PATIENT'S REPORTED VISUAL ACUITY WAS 1.2. POSTOPERATIVELY, THE PATIENT'S VISION WAS STATED AS BEING GOOD WITH NO PROBLEMS. SUTURES WERE REQUIRED, BUT THERE WAS NO REPORTED HEALTH DAMAGE AFTER SURGERY. THE REPLACEMENT IOL MODEL IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163955 CLARIFLEX INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. CLRFLXC 05050474501461

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention