MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

Model Number	MA60AC
Medical Device Problem Codes	Material Discolored (1170); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Corneal Edema (1791); Endophthalmitis (1835); Eye Injury (1845); Inflammation (1932); Intraocular Pressure Increased (1937); Blurred Vision (2137); Unspecified Eye / Vision Problem (4471)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient had blurry vision.The patient suspects a possible displacement of the implant.Additional information has been requested, received and patient¿s daughter stated that she does not know exactly what her mother¿s condition was but mentioned having heard about corneal edema at the hospital.
Additional Manufacturer Narrative
The product was not returned.A photo was provided of a company iol product label placed on the front of a patient id card.The serial number was obscured by a by a blue oval.However, the 2d barcode was visible.The product information was obtainable from the 2d barcode.Based on the provided label, the lens serial number is 15156917084, ma60ac 21.5 diopter.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.All iols are terminally sterilized with 100% ethylene oxide sterilization.Company manufacturing site uses an overkill sterilization approach, which greatly exceeds the minimum requirements for sterility.Critical parameters for sterilization cycles are recorded and retained for every sterilization load to demonstrate that the acceptance criteria for the sterilization process are met.The reporters were the patient and the patient caregiver.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received stating that the initial implantation surgery was complicated by an intraoperative capsular rupture, after which the company lens was implanted in the ciliary sulcus.On (b)(6) 2025, the patient developed endophthalmitis requiring an 8-day hospitalization and antibiotic injections.During a slit lamp examination, the implanted iol was observed to present a fine surface deposit described as ¿fogging".Rigid, sharp haptics causing capsular rupture.Suspicion of iol defect from reporter for this capsular rupture or inappropriate choice (by hcp) of a rigid-haptic iol implanted in the sulcus which caused indentation/scratching of the iris at 12 o¿clock, indentation of the sulcus at 6 o¿clock.Loss of vision was avoided by emergency antibiotic injections.Suspected mixed infection: bacterial + fungal.Corticosteroids alone worsen visual acuity and fogging, suggestive of fungal+bacterial involvement according to the reporter.Corticosteroids combined with antibiotics were better tolerated.Persistent purulent rim along the lower eyelid margin, worsening astigmatism probably related to the infection.Secondary glaucoma - intraocular pressure increased to 60 mmhg despite an open iridocorneal angle (which is, according to the reporter a possible signal of underlying viral or bacterial latent infection).Possible pmma allergy reported.

• Brand Name: ACRYSOF MULTIPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23510404
• Report Number: 1119421-2025-02892
• Device Sequence Number: 13230967
• Product Code: HQL
• UDI-Device Identifier: 00380652552554
• UDI-Public: (01)00380652552554(17)260303(11)210305(10)15156917
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2026
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.215
• Device Lot Number: 15156917
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 04/03/2026
• Date Device Manufactured: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTIBIOTIC INJECTIONS
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female