MAUDE Adverse Event Report: Alcon Research, LLC - Huntington AcrySof Singlepiece IOL; Intraocular Lens

Model Number	SA60AT
Medical Device Problem Codes	Break (1069); Failure to Deliver (2338)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A non healthcare professional reported that during an intraocular lens implantation surgery the lens haptic gets stuck in the injector, causing the haptic to break when the injector was retracted.Surgery was completed on the same day by using the replacement lens.
Additional Manufacturer Narrative
A product was not returned for analysis.A batch 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 medical device file were met.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 ; +1(800)757-9780
• MDR Report Key: 50614435
• Report Number: 1119421-2026-01827
• Device Sequence Number: 10559695
• Product Code: HQL
• UDI-Device Identifier: 00380652555890
• UDI-Public: (01)00380652555890(17)300510(11)250512(10)16035630
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2026

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: Health Professional
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.245
• Device Lot Number: 16035630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 05/12/2025
• 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
• Patient Sex: Unknown