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

Model Number	SN60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	06/11/2025
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 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).
Event or Problem Description
A physician via study reported that following cataract surgery with an intraocular lens (iol) implant procedure, patient had a mild hyperopic residual refraction since visits 2 (b)(6) 2024, and visit 2a (b)(6) 2024, at that moment patient vision quality was deemed as good and it was not considered as an adverse event since no symptoms where present.On visit 5a (b)(6) 2025, patient had a visual acuity of less than 20/20, so they made an unscheduled appointment to evaluate if patient was eligible for lasik which was performed on (b)(6) 2025, after the appointment patient was deemed as a good candidate for lasik surgery since visual acuity was caused by mild hyperopia but after the appointment patient told that had to think about having another surgery before accepting the procedure, the procedure was performed on (b)(6) 2025, after that an unscheduled visit was performed on (b)(6) 2025 where we found a good refractive result and the event was deemed as a resolved event.There are two medical device reports associated with this patient.This file is for right eye.

• Brand Name: ACRYSOF IQ NATURAL 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: 23069781
• Report Number: 1119421-2025-02487
• Device Sequence Number: 10065069
• Product Code: HQL
• UDI-Device Identifier: 00380655093276
• UDI-Public: (01)00380655093276(17)270322(11)220324(10)15378697
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.240
• Device Lot Number: 15378697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 09/16/2025
• Date Device Manufactured: 03/24/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female