MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number	ACU0T0
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907); Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported an issue that occurred during a cataract surgery involving the implantation of an intraocular lens (iol).At the iol insertion stage, they observed that the plunger of the iol cartridge was loose and had fallen back into the tray.They reinserted the plunger and depressed it, at which point it was noticed that the distal end had advanced past the lens.The plunger was then removed, rotated at 180°, and readvanced.Following this adjustment, the lens advanced through the cartridge as expected.Once the iol was placed in the eye, a central scratch on the lens was identified.They reconfirmed the presence of scratch by aspirating in front of and behind the lens; the defect remained persistent.As a result, the lens was explanted and replaced with a new lens in an initial procedure.The physician suspects that the scratch was caused due to initial advancement of the plunger in the incorrect orientation¿allowing the distal end to pass beyond the lens.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
The 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).
Additional Manufacturer Narrative
The product was not returned.The root cause could not be determined without physical evaluation of the product.Plungers are inserted with a device that ensures correct placement.The plunger lock holds the plunger in position until removed.The customer indicated they reinserted the plunger upside down causing it to advance over the lens.The customer indicated they removed the plunger and reinserted it again after rotating it 180 degrees.The lens was delivered and exhibited damage most likely caused by the previous override.It is unknown if the plunger was inadvertently retracted.Per the instructions for use (ifu), do not attempt to retract the plunger after the plunger lock has been removed or plunger damage may result.Retracting the plunger can pull the tabs outside of the barrel and cause the plunger to release from the device.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH 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 ; 8007579780
• MDR Report Key: 24614662
• Report Number: 1119421-2026-00555
• Device Sequence Number: 9575742
• Product Code: KYB
• UDI-Device Identifier: 00380652395304
• UDI-Public: (01)00380652395304(17)280723(11)250725(10)16078354
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: ACU0T0
• Device Lot Number: 16078354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/30/2026
• Date Device Manufactured: 07/25/2025
• 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