BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 18834782 · Received March 5, 2024

    Report

    Report Number
    1119421-2024-00399
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    October 21, 2020
    Report Date
    May 27, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN H.3., H.6., AND H.10. THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. 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% CYCLOPENTOLATE 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 % CYCLOPENTOLATE MAY BE EFFECTIVE FOR ASTHENOPIA DEVELOPING AFTER CATARACT SURGERY, ESPECIALLY AMONG PATIENTS WITH MULTIFOCAL 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 66-YEAR-OLD MALE PATIENT EXPERIENCED ASTHENOPIA AFTER CATARACT SURGERY AND IOL IMPLANTATION AND WAS TREATED WITH 0.05% CYPLEGIN OPHTHALMIC SOLUTION EYE DROPS. THE PATIENT WAS IMPROVING ON (B)(6) 2020. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 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
    165520 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SN60WF 12652345

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention