BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF SINGLEPIECE IOL

    MDR report key: 23850122 · Received December 19, 2025

    Report

    Report Number
    1119421-2025-03189
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Report Date
    December 19, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED. THE LITERATURE REPORT DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. LOT SPECIFIC REVIEWS FOR SIMILAR COMPLAINTS OR NON-CONFORMANCES COULD NOT BE CONDUCTED. HOWEVER, BEFORE PRODUCTION RELEASE, EACH DEVICE HISTORY RECORD IS REVIEWED TO ENSURE THAT THE PRODUCT MET THE REQUIRED SPECIFICATIONS AND RELEASE CRITERIA. ROOT CAUSE COULD NOT BE DETERMINED. THIS FILE WAS OPENED FROM A LITERATURE REPORT: LITERATURE REPORT: ARAVIND PSEUDOEXFOLIATION STUDY (APEX): 10-YEAR POSTOPERATIVE RESULTS. THE PURPOSE OF THE STUDY WAS TO COMPARE LONG-TERM (10-YEAR) BEST CORRECTED VISUAL ACUITY (BCVA) AND COMPLICATION RATES OF INTRAOCULAR LENS (IOL) DECENTRATION AND NEODYMIUM DOPED YTTRIUM ALUMINUM GARNET (ND:YAG) CAPSULOTOMY FOR POSTERIOR CAPSULE OPACIFICATION (PCO) IN EYES WITH AND WITHOUT PSEUDOEXFOLIATION (PEX) AFTER UNDERGOING CATARACT SURGERY. THE STUDY CONCLUDED: THIS IS THE ONLY LONG-TERM, LARGE SCALE PROSPECTIVE COMPARATIVE STUDY USING EXPERIENCED SURGEONS EVALUATING BOTH CAPSULAR TENSION RINGS (CTRS)AND IOL TYPES IN EYES WITH PEX WITHOUT PREOPERATIVE AND INTRAOPERATIVE ZONULAR WEAKNESS AND SMALL PUPILS. AT 10 YEARS POSTOPERATIVELY (MOST OF A LIFE EXPECTANCY), WE FOUND NO DIFFERENCES BETWEEN EYES WITH AND WITHOUT UNCOMPLICATED PEX AND HAVING A 1- OR 3-PIECE IOL OR CTRS. HARIPRIYA A ET.AL., ARAVIND PSEUDOEXFOLIATION STUDY (APEX): 10-YEAR POSTOPERATIVE RESULTS IN THE AMERICAN JOURNAL OF OPHTHALMOLOGY. 2025; (VOL. 270: PP. 1¿10) THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED VIA LITERATURE ARTICLE TO COMPARE LONG-TERM (10-YEAR) BEST- CORRECTED VISUAL ACUITY (BCVA) AND COMPLICATION RATES OF INTRAOCULAR LENS (IOL) DECENTRATION AND NEODYMIUM- DOPED YTTRIUM ALUMINUM GARNET (ND:YAG) CAPSULOTOMY FOR POSTERIOR CAPSULE OPACIFICATION (PCO) IN EYES WITH AND WITHOUT PSEUDOEXFOLIATION (PEX) AFTER UNDERGOING CATARACT SURGERY. DESIGN: CLINICAL COHORT STUDY USING RANDOMIZED CONTROL TRIAL DATA. SUBJECTS AND CONTROLS: A TOTAL OF 930 EYES WITH CATARACT AND PEX WITHOUT PHACODONESIS, CLINICALLY SHALLOW ANTERIOR CHAMBERS, OR PUPIL SIZE < 4 MM AND 476 CON- TROLS WITH CATARACT BUT WITHOUT PEX. METHODS: THEY RANDOMIZED BOTH GROUPS SEPARATELY TO RECEIVE EITHER A SINGLE-PIECE ACRYLIC IOL (INTRAOCULAR LENS) OR A 3-PIECE ACRYLIC IOL. THEY FURTHER RANDOMIZED THE PEX GROUP TO RECEIVE OR NOT RECEIVE CAPSULAR TENSION RINGS (CTRS). EXPERIENCED SURGEONS PERFORMED PHACOEMULSIFICATION WITH THE INSERTION OF AN IOL IN ALL EYES, AND WE FOLLOWED ALL PATIENTS AT 1 DAY, 1 MONTH, 3 MONTHS, 1 YEAR, AND YEARLY THEREAFTER FOR 10 YEARS. THIS FILE IS ABOUT THE STUDY EVALUATED COMPLICATION RATES ASSOCIATED WITH SINGLE-PIECE COMPANY IOL SPECIFICALLY FOCUSING ON THE INCIDENCE OF IOL DECENTRATION. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 3 OF 4. HARIPRIYA A ET.AL., ARAVIND PSEUDOEXFOLIATION STUDY (APEX): 10-YEAR POSTOPERATIVE RESULTS IN THE AMERICAN JOURNAL OF OPHTHALMOLOGY. 2025; (VOL. 270: PP. 1¿10).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2387392 ACRYSOF SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SA60AT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown