BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 11780848 · Received May 5, 2021

    Report

    Report Number
    2648035-2021-07755
    Event Type
    Injury
    Date Received
    May 5, 2021
    Report Date
    February 7, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474528918
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION/CORRECTED DATA: ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT INDICATED THAT THE LENS IMPLANTED IN HER LEFT EYE WAS A (B)(6), 15.0 DIOPTER, SN (B)(6). THE DATE OF IMPLANT WHICH THE PATIENT INITIALLY HAD REPORTED IT TO BE "(B)(6) 2020" BASED ON THE ADDITIONAL INFORMATION WAS INDICATED TO BE "(B)(6) 2020". THE PATIENT REPORTED THAT SHE EXPERIENCED COMPLICATIONS WHICH INCLUDE: A POSTERIOR CAPSULAR RENT, RETAINED LENS FRAGMENTS, RETAINED VITREOUS STRANDS, ELEVATED EYE PRESSURE I.E. GLAUCOMA, BACTERIAL INFECTIONS, ONGOING INFLAMMATION, LOSS OF VISION AND PAIN. THE PATIENT INDICATED SHE UNDERWENT MULTIPLE ADDITIONAL SURGICAL PROCEDURES TO RESTORE THE VISION AND THE HEALTH OF HER EYE. THAT THE GOAL OF THE ORIGINAL SURGERY WAS 20/30 WHICH WAS HER CORRECTED VISION PRIOR TO THE SURGERY AND AFTER ONGOING TREATMENT WITH DRUG THERAPIES TO RESTORE HER VISION, INCLUDING A CORNEA TRANSPLANT, HER OPHTHALMOLOGIST HAS INFORMED THE PATIENT THAT HER VISION IS 20/400 IN THE AFFECTED EYE. THE VISION IN THE EYE IS CLOUDY AND FOGGY. THE EYE IS SENSITIVE TO GLARE, LIGHT, OFTEN PAINFUL, AND TIRES EASILY. THE PATIENT USES EYEDROPS DAILY THAT ARE NECESSARY TO PREVENT REJECTION OF THE TRANSPLANTED CORNEA, TO REDUCE INFLAMMATION, AND TO REGULATE THE EYE PRESSURE. THE PATIENT INDICATED THAT AT TIMES, THE PAIN HAS BEEN SEVERE REQUIRING PRESCRIPTION PAIN MEDICATIONS. THE PATIENT REPORTED OF CHRONIC INFLAMMATION IN THE OPERATIVE EYE AND THE LOSS OF HER VISION, WHICH HAS BEEN EMOTIONALLY DIFFICULT, CAUSING HER GREAT EMOTIONAL DISTRESS THE PATIENT FEELS THAT SHE IS DEBILITATED WHICH SHE CANNOT PERFORM AND ENJOY THE ACTIVITIES OF HER DAILY LIFE. THE PATIENT HAS TROUBLE READING AND SEEING CLOSE UP. THAT SHE WAS GIVEN GLASSES AND THAT DOES NOT WORK FOR HER EITHER. THE PATIENT USES THREE (3) MEDICATIONS WHICH WERE PRESCRIBED TO HER TWICE/DAILY. THE MEDICATIONS ARE NOT FOR DRY EYE AND PATIENT STATED THAT SHE DOES NOT HAVE DRY EYE. THE PATIENT INDICATED THAT SOMEDAYS HER VISION IS BETTER AND SOMEDAYS IT IS WORSE. THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED, THE BEST ESTIMATE DATE IS (B)(6) 2020. SECTION D4: SERIAL NUMBER: (B)(6). SECTION D4: CATALOG NUMBER: ZA90030150. SECTION D4: EXPIRATION DATE: (B)(6) 2024. SECTION D4: UDI NUMBER: (B)(4). SECTION D6A: IF IMPLANTED, GIVE DATE: (B)(6) 2020. SECTION H3(NO): 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. SECTION H4: DEVICE MANUFACTURE DATE: DEC 12, 2019. ADDITIONAL CODES ADDED: SECTION H6: HEALTH EFFECT - IMPACT CODE: 4625 - ADDITIONAL SURGERY USED TO CAPTURE (CORNEAL TRANSPLANT, SECONDARY SURGICAL INTERVENTION, INCISION ENLARGED, SUTURES, UNPLANNED VITRECTOMY). SECTION H6: HEALTH EFFECT - IMPACT CODE: 4644 - MEDICATION REQUIRED. SECTION H6: HEALTH EFFECT - CLINICAL CODE: 2140 - VISUAL DISTURBANCES. SECTION H6: HEALTH EFFECT - CLINICAL CODE: 2138 - VISUAL IMPAIRMENT. SECTION H6: HEALTH EFFECT - CLINICAL CODE: 2142 - VITREOUS LOSS. SECTION H6: HEALTH EFFECT - CLINICAL CODE: 1875 - GLAUCOMA. SECTION H6: HEALTH EFFECT - CLINICAL CODE: 4466 - EYE INFECTIONS. SECTION H6: HEALTH EFFECT - CLINICAL CODE: 1866 - VITREOUS FLOATERS. SECTION H6: HEALTH EFFECT - CLINICAL CODE: 2329 - DISTRESS. SECTION H6: HEALTH EFFECT - CLINICAL CODE: 1937 - INTRAOCULAR PRESSURE INCREASED. SECTION H6: HEALTH EFFECT - CLINICAL CODE: 4467 - EYE PAIN. NOTE: THE INFORMATION PROVIDED IS FROM THE PATIENT AND NOT FROM THE HEALTHCARE PROVIDER (PHYSICIAN). BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN IF THE ISSUES REPORTED PERTAIN TO THE ORIGINAL LENS OR THE REPLACEMENT LENS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    WEIGHT & ETHNICITY: INFORMATION UNKNOWN, NOT PROVIDED. DATE OF EVENT: EXACT DATES NOT PROVIDED, THE BEST ESTIMATE DATE IS (B)(6) 2020. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. A COMPLETE CATALOG NUMBER IS UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: A COMPLETE UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE (2021 REPORTS) : IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. EXPLANT DATE (2021 REPORTS) : IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. DEVICE EVALUATED BY MFR-OTHER (81): THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, TO DATE, THE INFORMATION HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A PATIENT REPORTED HAVING UNDERGONE CATARACT SURGERY IN THE LEFT EYE IN (B)(6) 2020. AFTER THE LENS WAS INSERTED INTO THE EYE AND UNFOLDED, THE DOCTOR NOTICED THAT THE TRAILING HAPTIC WAS BROKEN. IT WAS INDICATED THAT THE TRAILING HAPTIC PIERCED THE CAPSULE; THEREFORE, THE INCISION WAS ENLARGED AND THE LENS WAS REMOVED FROM THE EYE ON THE SAME DAY. A REPLACEMENT LENS FROM A DIFFERENT COMPANY WAS IMPLANTED AND A SUTURE WAS USED. THE PATIENT HAD SOME EDEMA/SWELLING. ON THE NEXT DAY POST-OPERATIONAL VISIT, THE COMPETITOR¿S LENS HAD DISLOCATED AND AT THAT POINT, THE PATIENT WAS REFERRED TO A RETINA SPECIALIST WHO PERFORMED A VITRECTOMY ON THE EYE. THE PATIENT COMPLAINED OF FLOATERS IN HER EYE WITH HER CURRENT COMPETITOR¿S IMPLANT AND INDICATED THAT SHE HAS HAD SEVERAL SURGERIES SINCE HER CATARACT SURGERY. THE PATIENT REPORTED HAVING UNDERGONE A CORNEA TRANSPLANT AND REPORTEDLY NOW MAY HAVE GLAUCOMA. THE PATIENT DOES NOT SEE WELL OUT OF LEFT EYE AND HER VISION IS BETTER IN THE MORNING, BUT TERRIBLE IN THE EVENINGS. THE PATIENT IS ABLE TO PERFORM HER DAILY TASKS; HOWEVER, SHE STILL HAS PAIN IN HER EYE WITH THE CURRENT IMPLANT. THE PATIENT HAS A JOHNSON AND JOHNSON LENS IN HER RIGHT EYE WITH NO REPORTED ISSUES WITH THAT EYE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677881 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZA9003 05050474528918

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention