BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SENSAR

    MDR report key: 13983059 · Received April 1, 2022

    Report

    Report Number
    3012236936-2022-00844
    Event Type
    Injury
    Date Received
    April 1, 2022
    Report Date
    April 1, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE: 63.3 ± 7.0. SEX/GENDER: MALE:FEMALE: 27:23. WEIGHT & ETHNICITY: INFORMATION UNKNOWN, NOT PROVIDED. DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS (B)(6) 2020. A COMPLETE CATALOG NUMBER IS UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: THE UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS REMAINS IMPLANTED. THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS THE LENS REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. AS THE SERIAL NUMBER OF THE DEVICE IS UNKNOWN NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: DO, JR., PARK, SJ., MUKAI, R., KIM, HK., SHIN, JP., PARK, DH., A 1-YEAR PROSPECTIVE COMPARATIVE STUDY OF SUTURELESS FLANGED INTRAOCULAR LENS FIXATION AND CONVENTIONAL SUTURED SCLERAL FIXATION IN INTRAOCULAR LENS DISLOCATION, OPHTHALMOLOGICA 2021; 244(1):PP.68¿75. 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: A 1-YEAR PROSPECTIVE COMPARATIVE STUDY OF SUTURELESS FLANGED INTRAOCULAR LENS FIXATION AND CONVENTIONAL SUTURED SCLERAL FIXATION IN INTRAOCULAR LENS DISLOCATION. THIS PROSPECTIVE, COMPARATIVE COHORT STUDY WAS DONE TO COMPARE SURGICAL OUTCOMES OF SUTURELESS FLANGED INTRAOCULAR LENS (IOL) FIXATION AND CONVENTIONAL SUTURED SCLERAL FIXATION (SF) FOR SECONDARY IOL IMPLANTATION IN PATIENTS WITH IOL DISLOCATION. THE STUDY INCLUDED 53 PATIENTS (N=53 EYES) FROM THE SUTURED SF GROUP AND 50 PATIENTS (N=50 EYES) FROM THE FLANGED IOL SENSAR AR40E (ABBOTT MEDICAL OPTICS INC.) FIXATION GROUP. WITHIN 1 POSTOPERATIVE MONTH, EARLY COMPLICATIONS WERE VITREOUS HEMORRHAGE (N=2), HYPOTONY (N=1) AND INTRAOCULAR PRESSURE (IOP) ELEVATION (N=1); AND BETWEEN 1 AND 12 MONTHS, LATE COMPLICATIONS WERE IRIS CAPTURE OF IOL (N=3) AND CYSTOID MACULAR EDEMA (CME) (N=1). THERE WERE NO FURTHER INTERVENTIONS REPORTED. IT WAS ALSO STATED THAT OPERATING TIME WAS SIGNIFICANTLY SHORTER FOR THE FLANGED IOL FIXATION GROUP IN TREATING IOL DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869605 UNK_SENSAR INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other