BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ RESTOR SINGLEPIECE IOL

    MDR report key: 18824971 · Received March 4, 2024

    Report

    Report Number
    1119421-2024-00378
    Event Type
    Injury
    Date Received
    March 4, 2024
    Date of Event
    October 30, 2019
    Report Date
    May 28, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. LITERATURE CITATION: N,K. ET AL., EFFECT OF TOPICAL 0.05% CYCLOPENTOLATE ON ASTHENOPIA AFTER CATARACT SURGERY. JAPANESE JOURNAL OF CLINICAL OPHTHALMOLOGY. 2023 SEP; 77 (9): 1203-1208. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED. THE COMPLAINT WAS FOR CREATED FOR PATIENT 3 OF 3, BASED ON A LITERATURE REPORT. THE LITERATURE REPORT WAS REVIEWED. THE COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ASSOCIATED PRODUCTS ARE UNKNOWN. THE ROOT CAUSE COULD NOT BE DETERMINED. A MALFUNCTION HAS NOT BEEN INDICATED AGAINST THE LENS. THE FILE HAS BEEN OPENED FROM A LITERATURE REPORT: EFFECT OF TOPICAL 0.05% ANTI-MUSCARINIC EYE DROPS ON ASTHENOPIA AFTER CATARACT SURGERY. IN THIS RETROSPECTIVE, OBSERVATIONAL CLINICAL STUDY, PATIENTS WITH ASTHENOPIA AFTER CATARACT SURGERY, WITH NO KNOWN CAUSE OTHER THAN ACCOMMODATIVE SPASMS WERE INCLUDED. TOPICAL TREATMENT WITH 0.05 % ANTI-MUSCARINIC EYE DROPS MAY BE EFFECTIVE FOR ASTHENOPIA DEVELOPING AFTER CATARACT SURGERY, ESPECIALLY AMONG PATIENTS WITH MULTIFOCAL INTRAOCULAR LENSES (IOLS). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A RESEARCH ARTICLE WAS PUBLISHED WITH PURPOSE OF WE ENCOUNTER CASES OF OCULAR FATIGUE AFTER CATARACT SURGERY. IT HAS BEEN REPORTED THAT APPLICATION OF 0.05 % CYCLOPENTOLATE IS EFFECTIVE FOR PHAKIC PATIENTS WITH ASTHENOPIA WITH ACCOMMODATIVE SPASMS. WE EVALUATED THE EFFECT OF TOPICAL 0.05% CYCLOPENTOLATE ON PSEUDOPHAKIC PATIENTS WITH ASTHENOPIA. IN THIS RETROSPECTIVE, OBSERVATIONAL CLINICAL STUDY, PATIENTS WITH ASTHENOPIA AFTER CATARACT SURGERY, WITH NO KNOWN CAUSE OTHER THAN ACCOMMODATIVE SPASMS WERE INCLUDED. THERE WERE 6 PATIENTS (3 MALE, 3 FEMALE) WITH 11 EYES. 4 EYES HAD MONOFOCAL INTRAOCULAR LENSES (IOLS), AND 7 EYES HAD MULTIFOCAL IOLS. THE AVERAGE AGE WAS 68.8 TO 5.4. RESULT OF STUDY INCLUDED THE PATIENTS STARTED THEIR TOPICAL TREATMENT 6.8 SAT 3.0 MONTHS POSTOPERATIVELY AND THE EVALUATION DAY WAS 1.7 SAT 1.2 MONTHS AFTER INITIATING THE TREATMENT ON AVERAGE. ALL PATIENTS HAD ELEVATED HFC VALUES (68.6 SAT 5.0) ON THE DAY OF TREATMENT INITIATION AND HAD SIGN SURFACE CANDY LOWER HFC VALUES (58.8 SAT 2.4, P< 0.01) ON THE EVALUATION DAY. FOUR OF SIX PATIENTS, ALL OF WHOM HAD MULTIFOCAL IOLS, EXPERIENCED RELIEF FROM SUBJECTIVE SYMPTOMS. THE STUDY WAS CONCLUDING THAT TOPICAL TREATMENT WITH 0.05 % CYCLOPENTOLATE MAY BE EFFECTIVE FOR ASTHENOPIA DEVELOPING AFTER CATARACT SURGERY, ESPECIALLY AMONG PATIENTS WITH MULTIFOCAL IOLS. THIS FILE BELONGS TO A 68-YEAR-OLD FEMALE PATIENT EXPERIENCED ASTHENOPIA AFTER CATARACT SURGERY AND IOL IMPLANTATION AND WAS TREATED WITH 0.05% CYCLOPENTOLATE HYDROCHLORIDE OPHTHALMIC SOLUTION EYE DROPS. THE PATIENT WAS IMPROVING ON (B)(6) 2019. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 3 OF 3. LITERATURE CITATION: N,K. ET AL., EFFECT OF TOPICAL 0.05% CYCLOPENTOLATE ON ASTHENOPIA AFTER CATARACT SURGERY. JAPANESE JOURNAL OF CLINICAL OPHTHALMOLOGY. 2023 SEP; 77 (9): 1203-1208.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060008 ACRYSOF IQ RESTOR SINGLEPIECE IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON SV25T0 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention