BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 20057991 · Received August 23, 2024

    Report

    Report Number
    3012236936-2024-000236
    Event Type
    Injury
    Date Received
    August 23, 2024
    Report Date
    September 24, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474765337
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, DATE OF BIRTH: UNKNOWN/NOT PROVIDED. SECTION A3B, A4, A5, AND A6, PATIENT INFORMATION: UNKNOWN/NOT PROVIDED. SECTION B3, DATE OF EVENT: THE CUSTOMER SAID, ¿POST OPERATIVELY¿. SECTION D6B, IF EXPLANTED, GIVE DATE: UNKNOWN, THE BEST ESTIMATE IS PRIOR TO (B)(6) WHEN WE WERE NOTIFIED THE PRODUCT WAS RECEIVED BY THE JOHNSON AND JOHNSON INVESTIGATION SITE. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION H3: EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: TWO SPECIMEN CONTAINERS WERE RECEIVED. ONE MARKED ON THE CAP WITH A "L" AND THE OTHER MARKED WITH A "R". TWO LENSES WERE RECEIVED. THE COMPLAINT DID NOT SPECIFY WHICH WAS ASSOCIATED WITH THIS EVENT SO BOTH WERE EVALUATED IN THIS COMPLAINT. THE LENS MARKED "L" PRESENTED CUT IN HALF. THE LENS WAS CLEANED AND NO FURTHER ISSUES WERE IDENTIFIED. THE LENS MARKED "R" WAS RECEIVED CUT IN HALF WHICH INCLUDED A HAPTIC THAT WAS CUT AND WAS MISSING. NO FURTHER ISSUES COULD BE IDENTIFIED. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENTS BOTH RIGHT AND LEFT EYE. THE DIRECTIONS FOR USE WERE FOLLOWED. DURING A POST-OPERATIVE EXAMINATION, THE PATIENT REPORTED GLARE AND HALOS. AS OF JUNE 20, 2024, THE PATIENT'S OUTCOME WAS REPORTED AS FULLY RECOVERED. HOWEVER, IT WAS ALSO REPORTED THAT THE PATIENT IS SCHEDULED FOR AN EXPLANT. THE EXPLANT FOR BOTH EYES SUBSEQUENTLY OCCURRED. THE SERIAL NUMBERS WERE PROVIDED BUT THE EYE WAS NOT SPECIFIED. NO FURTHER INFORMATION WAS PROVIDED. NOTE, THE MDR FOR SERIAL # (B)(6) IS CAPTURED IN MANUFACTURER REPORT NUMBER 3012236936-2024-0002362 . THE OTHER EYE SERIAL #: (B)(6) IS CAPTURED IN MANUFACTURER REPORT NUMBER 3012236936-2024-0002363.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481343 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DXW300 05050474765337

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention