BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16464735 · Received March 1, 2023

    Report

    Report Number
    3012236936-2023-00300
    Event Type
    Injury
    Date Received
    March 1, 2023
    Report Date
    March 1, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE/DATE OF BIRTH: NO EXACT AGES WERE PROVIDED, MEAN ± SD (RANGE) 69 ± 9.2 (52 TO 88). GENDER: 31 PATIENTS WERE INCLUDED IN THE ANALYSIS, 15 (48 %) MEN AND 16 (52%) WOMEN. DATE OF EVENT: EXACT DATES NOT PROVIDED. ARTICLE ACCEPTANCE DATE IS (B)(6) 2022. THE STUDY WAS CONDUCTED BETWEEN NOVEMBER 2015 AND MAY 2021. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: UNKNOWN/ NOT PROVIDED EXPLANT DATE: N/A, AS LENS REMAINS IMPLANTED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED (THE LENS REMAINS IMPLANTED). THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED, AND THE REPORTED EVENT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED, AND COMPLAINT HISTORY WERE NOT REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. CITATION: STEWART, S.A.; MCNEELY, R.N.; CHAN, W.C.; MOORE, J.E.; VISUAL AND REFRACTIVE OUTCOMES FOLLOWING EXCHANGE OF AN OPACIFIED MULTIFOCAL INTRAOCULAR LENS; (B)(6) 2022; CLINICAL OPHTHALMOLOGY 2022:16 1883¿1891 ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: VISUAL AND REFRACTIVE OUTCOMES FOLLOWING EXCHANGE OF AN OPACIFIED MULTIFOCAL INTRAOCULAR LENS A RETROSPECTIVE COHORT STUDY WAS DONE TO ASSESS THE VISUAL AND REFRACTIVE OUTCOMES FOLLOWING EXCHANGE OF AN OPACIFIED MULTIFOCAL INTRAOCULAR LENS (IOL). A TOTAL OF 37 EYES OF 31 PATIENTS UNDERWENT IOL EXCHANGE DUE TO THE OPACIFICATION OF A MULTIFOCAL IOL (LENTIS MPLUS MULTIFOCAL IOL; OCULENTIS GMBH). OF THE 37 EYES THAT UNDERWENT IOL EXPLANTATION, 3 TECNIS ZA9003 3-PIECE MONOFOCAL (JOHNSON & JOHNSON VISION) WERE USED AS THE EXCHANGE (2 WERE IMPLANTED IN THE SULCUS AND 1 WAS IMPLANTED IN THE SULCUS WITH OPTIC CAPTURE). INTRAOPERATIVE COMPLICATIONS REPORTED INCLUDE VITREOUS PROLAPSE (N=9 EYES; ANTERIOR VITRECTOMY WAS PERFORMED AS MANAGEMENT), IRIS PROLAPSE (N=2 EYES), IRIS HAEMORRHAGE (N=1 EYE), LIMITED ZONULODIALYSIS (N=3 EYES), AND CAPSULAR RUPTURE (N=1 EYE). POSTOPERATIVE COMPLICATIONS REPORTED INCLUDE MYOPIC ASTIGMATISM (0.00/-1.25 × 80) (N=1 EYE) WHO UNDERWENT LASER IN SITU KERATOMILEUSIS (LASIK) 6 MONTHS POST-EXCHANGE, MYOPIC REFRACTIVE ERROR (-1.00/-0.25 × 5) (N=1 EYE) WHO UNDERWENT PHOTOREFRACTIVE KERATECTOMY (PRK) 12 MONTHS POST-EXCHANGE, DRY EYE (N=3 EYES), POSTERIOR CAPSULAR THICKENING (N=1 EYE), AND BORDERLINE ELEVATED INTRAOCULAR PRESSURE (N=1 EYE) WITH A 3-PIECE IOL IN THE SULCUS, AND FURTHER FOLLOW-UP WAS PLANNED. IT WAS FURTHER REPORTED THAT IN THE MULTIFOCAL TO MONOFOCAL GROUP, 33% OF EYES WERE NOT WITHIN THE ±1.0 D OF THE ATTEMPTED SPHERICAL EQUIVALENT (SE). IT IS NOT CLEAR IF THESE COMPLICATIONS OCCURRED IN THE EYES IMPLANTED WITH TECNIS ZA9003 3-PIECE MONOFOCAL (JOHNSON & JOHNSON VISION) OR THE OTHER PRODUCTS. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011522 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention