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

Model Number	SN60AT
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A healthcare professional reported that following an intraocular lens (iol) implant procedure the patient had iols with significant glistening's that seem to be visually significant.The symptoms continued.There are two medical device reports associated with this patient.This report is associated with the right eye.
Additional Manufacturer Narrative
Correction information was provided in d.10.Additional information was provided in h.3., h.6.And h.11.The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified cartridge and non qualified viscoelastic were indicated.It is unknown if a qualified handpiece was used.The product investigation could not identify a root cause for the reported complaint.The product was not returned.The implantation was in 2022.The lens remains implanted.Each lens is subjected to a 100 percentage assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.File will be reopened if new information or the sample is returned.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 22011247
• Report Number: 1119421-2025-01374
• Device Sequence Number: 17481560
• Product Code: HQL
• UDI-Device Identifier: 00380650130334
• UDI-Public: (01)00380650130334(17)240229(11)190321(10)12698127
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.215
• Device Lot Number: 12698127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 07/10/2025
• Date Device Manufactured: 03/21/2019
• 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 III IOL , CARTRIDGE C.; PROVISC OVD.; UNSPECIFIED HANDPIECE INJECTOR.
• Patient Sex: Unknown