BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_MONOFOCAL IOL

    MDR report key: 21952677 · Received May 2, 2025

    Report

    Report Number
    3012236936-2025-000124
    Event Type
    Injury
    Date Received
    May 2, 2025
    Report Date
    May 2, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION A-2 PATIENT AGE/DATE OF BIRTH: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION A-3A PATIENT SEX: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION A-3B PATIENT GENDER: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION A-4 PATIENT WEIGHT: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION A-5 PATIENT ETHNICITY: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION A-6 PATIENT RACE: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION B-3 DATE OF EVENT: ARTICLE ACCEPTANCE DATE: 08-MAY-2024 SECTION D-1 BRAND NAME: UNKNOWN AS DEVICE SERIAL NUMBER WAS NOT PROVIDED SECTION D-4 MODEL NUMBER: UNKNOWN, AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. SECTION D-4 CATALOG NUMBER: UNKNOWN AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. SECTION D-4 DEVICE SERIAL NUMBER: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION D-4 DEVICE EXPIRATION DATE: UNKNOWN AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. SECTION D-4 UDI NUMBER: THE UNIQUE DEVICE IDENTIFIER (UDI) NUMBER IS UNKNOWN AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. SECTION D-6A DATE IMPLANTED: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION D-6B DATE EXPLANTED: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SECTION H-3 DEVICE EVALUATED BY MANUFACTURER: DEVICE SERIAL NUMBER IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. SECTION H-4 DEVICE MANUFACTURE DATE: UNKNOWN, AS DEVICE SERIAL NUMBER WAS NOT PROVIDED. CITATION: WANG, SERENA, FREEDMAN, SHARON F. COMPLICATIONS, VISUAL ACUITY, AND REFRACTIVE ERROR 3 YEARS AFTER SECONDARY INTRAOCULAR LENS IMPLANTATION FOR PEDIATRIC APHAKIA. 2024 AMERICAN ACADEMY OF OPHTHALMOLOGY. 131(10), 1196 - 1206. AN ATTEMPT WAS MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION REGARDING COMPLAINT HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A PEDIATRIC CATARACT REGISTRY STUDY WAS DONE TO REPORT THE CUMULATIVE INCIDENCE OF COMPLICATIONS AND TO DESCRIBE REFRACTIVE ERROR AND VISUAL ACUITY (VA) OUTCOMES IN CHILDREN UNDERGOING SECONDARY INTRAOCULAR LENS (IOL) IMPLANTATION AFTER PREVIOUS SURGERY FOR NONTRAUMATIC CATARACT. A TOTAL OF 108 EYES OF 80 CHILDREN (60 BILATERAL AND 48 UNILATERAL) UNDERWENT SECONDARY IOL PLACEMENT. ONLY ONE EYE WAS IMPLANTED WITH TECNIS IN THE UNILATERAL GROUP WHILE 2 EYES WERE IMPLANTED WITH AMO IN THE BILATERAL GROUP. ALL OTHER EYES WERE IMPLANTED WITH EITHER HOYA, ALCON 1-PIECE, ALCON 3-PIECE, OR ALCON UNKNOWN. AT 5-YEARS POST-OP, COMPLICATIONS REPORTED ON THE BILATERAL GROUP INCLUDE GLAUCOMA (N=13 EYES), GLAUCOMA SUSPECT (N=4 EYE), VISUAL AXIS OPACIFICATION (N=14 EYES), PERIPHERAL ANTERIOR SYNECHIAE (N=1 EYE), AND IRIS-POSTERIOR SYNECHIAE (N=3 EYES) WHILE IN THE UNILATERAL GROUP, COMPLICATIONS REPORTED INCLUDE GLAUCOMA (N=5 EYES), GLAUCOMA SUSPECT (N=1 EYE), VISUAL AXIS OPACIFICATION (N=7 EYES), RETINAL DETACHMENT (N=1 EYE), IRIS-POSTERIOR SYNECHIAE (N=4 EYES), AND AN UNSPECIFIED OTHER COMPLICATION (N=1 EYE). INTERVENTIONS PERFORMED IN THE BILATERAL GROUP INCLUDE GLAUCOMA SURGERY (N=4 EYES) AND SURGERY TO CLEAR VISUAL AXIS (N=14 EYES) WHILE IN THE UNILATERAL GROUP, INTERVENTIONS PERFORMED INCLUDE GLAUCOMA SURGERY (N=3 EYES) AND SURGERY TO CLEAR VISUAL AXIS (N=5 EYES). AT 5-YEARS POST-OP, POSTOPERATIVE SPHERICAL EQUIVALENT REFRACTIVE ERROR AFTER SECONDARY INTRAOCULAR LENS IMPLANTATION BY LATERALITY REPORTED THE MEAN MEASURED POSTOPERATIVE REFRACTIVE ERROR OF +1.72 (+0.22 TO +3.22) AND +1.24 (+0.15 TO +2.34) IN THE BILATERAL GROUP AND UNILATERAL GROUP RESPECTIVELY. A MEAN REFRACTIVE ERROR OF +0.08 (-1.63 TO +1.78) AND -0.53 (-1.35 TO +0.28) WERE REPORTED ON THE BILATERAL GROUP AND UNILATERAL GROUP RESPECTIVELY. A MEAN MYOPIC SHIFT OF -2.11 (-3.10 TO -1.12) AND -2.31 (-3.61 TO -1.01) WERE REPORTED ON THE BILATERAL GROUP AND UNILATERAL GROUP RESPECTIVELY. THE MEDIAN VISUAL ACUITY (VA) WAS 20/63 (INTERQUARTILE RANGE (IQR), 20/50 - 20/100) FOR 42 BILATERAL CASES AND 20/400 (IQR, 20/ 160-20/800) FOR 33 UNILATERAL CASES. IT IS UNCLEAR IF THESE COMPLICATIONS OCCURRED IN THE EYES IMPLANTED WITH JNJ DEVICES (TECNIS AND AMO), OR THE OTHER NON-JNJ DEVICES." SERIOUS INJURY: YES DEVICE MALFUNCTION: UNKNOWN INTERVENTIONS: YES A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194692 UNK_MONOFOCAL IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention