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

Model Number	SA60AT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned in a specimen cup.Solution was dried on the lens.The lens was removed and cleaned with klrp for further evaluation.A power and resolution verification was conducted.The optical resolution is acceptable; lens meets specification for focal length equaling a 22.0 diopter lens.No lens issues observed.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.Associated products were provided; however, they would be unrelated to the "blurred vision" complaint.The product investigation could not identify a root cause for the reported complaint.The lens was returned and was cleaned with klrp for further evaluation.A power and resolution verification was conducted.The focal length and resolution were within specifications for a 22.0 diopter lens.No lens issues observed.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.Information was provided that the company 22.0 diopter lens model was replaced with a company 22.5 diopter lens model.Due to the exchange for a 0.5 higher diopter difference lens may suggest that the replacement lens model may have been an improved choice for the patient's vision needs.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
An administrative assistant reported that following intraocular lens (iol) implantation in the right eye, the patient experienced blurred vision the next day.The lens was removed and replaced with a company lens of different model and half diopter more power sulcus lens in a secondary procedure.The clinical reason for explant was that the lens was unstable in the patient's eye.There was no further impact to the patient.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
Additional information provided in section b.5.And h.11.Upon further review of the available information, it was determined that the initial report did not meet reporting criteria per regulation since the reported events were related to the anatomical condition of the patient (posterior capsule was unstable) and not related to product.No further reports required.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
According to the additional information received, the posterior capsule was unstable, that's why the lens kept falling to the back of the eye.Consequently, a secondary sulcus lens implantation was performed using a different lens.According to the surgeon, the event was not related to the product.

• Brand Name: ACRYSOF SINGLEPIECE 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: 24831881
• Report Number: 1119421-2026-00722
• Device Sequence Number: 18753708
• Product Code: HQL
• UDI-Device Identifier: 00380652555845
• UDI-Public: (01)00380652555845(17)301001(11)251003(10)16117876
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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 Model Number: SA60AT
• Device Catalogue Number: SA60AT.220
• Device Lot Number: 16117876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2025
• 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: MONARCH II LOADING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female