MAUDE Adverse Event Report: Alcon Research, LLC - Huntington AcrySof IQ Singlepiece IOL with ULTRASERT Delivery System; Lens, Guide, Intraocular

Model Number	AU00T0
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during surgery, it was noted that the lens had been preloaded upside down.As a result, when the surgeon deployed the lens, it had to be flipped within the eye.There was no patient harm.However, if corrective action had not been taken, patient harm was considered likely.Additional information has been requested but is not available at the time of this report.This report was received via regulatory agency.
Additional Manufacturer Narrative
The product was not returned for analysis.A device history 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 IQ Singlepiece IOL with ULTRASERT Delivery System
• Common Device Name: Lens, Guide, Intraocular
• 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: 50208152
• Report Number: 1119421-2026-01677
• Device Sequence Number: 5521387
• Product Code: KYB
• UDI-Device Identifier: 00380652394789
• UDI-Public: (01)00380652394789(17)281124(11)251126(10)16161131
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: Health Professional
• Device Model Number: AU00T0
• Device Lot Number: 16161131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 11/26/2025
• 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