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

Model Number	SA60AT
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A non-health care professional reported with a description of defect in the lens.There was no patient harm and no delay in surgery.Additional information has been requested but is not available at the time of this report.
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).

• 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: 24482480
• Report Number: 1119421-2026-00423
• Device Sequence Number: 14703200
• Product Code: HQL
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

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: Other
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.230
• Device Lot Number: 16074894
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown