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 Code	Dry Eye(s) (1814)
Date of Event	01/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product was not returned for analysis.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 non-healthcare professional reported that following an intraocular lens (iol) implantation procedure, the patient had been unable to read and experienced dry eyes.The patient stated that they had been going back and forth getting plugs inserted for dry eye management, but continued to experience symptoms, describing a sensation as if a shield came over their eyes, preventing them from reading more than one or two pages.They reported having tried different prescription lenses and glasses without relief.The patient also questioned whether there had been an issue with the intraocular lens used during their cataract surgery in 2021.They expressed significant distress regarding their vision since the surgery and indicated that they were planning to visit their eye doctor that morning due to ongoing problems.Additional information has been requested but is not available at the time of this report.There are two medical reports associated with this patient.This file belongs to 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: 25271546
• Report Number: 1119421-2026-01122
• Device Sequence Number: 21297500
• Product Code: HQL
• UDI-Device Identifier: 00380655093184
• UDI-Public: (01)00380655093184(17)260711(11)210713(10)15232045
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/11/2026
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.195
• Device Lot Number: 15232045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/25/2026
• Date Device Manufactured: 07/13/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Unknown