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	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; it was discarded.Complaint history and product history records were reviewed, and documentation indicated the product met release criteria.Root cause has not been identified.A photo was provided.The photo showed the device from part of the loading bay to the end of the nozzle tip.The view was from the top (door side).There appeared to be viscoelastic in the device.The plunger was oriented correctly.The plunger was retracted to mid-nozzle.The lens was visible partially exiting the tip of the device.The trailing haptic was correctly folded on the optic.Two thirds of the lens was advanced outside the tip.The leading haptic was unfolded or extended.Unable to determine as it was outside of the device.A photo of a label was also provided the serial number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported an issue which occurred during a cataract surgery involving intraocular lens (iol) implantation.While advancing the iol through the preloaded injector for implantation into the patient¿s eye, the leading haptic did not unfold properly inside the injector and could not be implanted as intended.Patient contact occurred.The procedure was completed using a backup iol of the same diopter on same day.The product is not available for return, it was discarded.

• 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 ; 8007579780
• MDR Report Key: 24232501
• Report Number: 1119421-2026-00211
• Device Sequence Number: 10229916
• Product Code: KYB
• UDI-Device Identifier: 00380652394765
• UDI-Public: (01)00380652394765(17)280511(11)250513(10)16035910
• Combination Product (Y/N): N
• Initial Reporter Country: NC
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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: 16035910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 02/02/2026
• Date Device Manufactured: 05/13/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC VISCOELASTIC SYSTEM
• Patient Sex: Unknown