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 Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, the surgeon noticed that the injector nozzle tip larger than normal and not able to introduce even after tunnel enlargement.Additional information was requested.
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).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned.A photo was provided.The used device was shown held by two ungloved fingers on the barrel.Only the anterior view of the device of the device was shown, from mid-barrel throughout the tip.The lens stop was removed.The plunger lock area was not visible in this photo.The plunger appeared to be oriented correctly.Viscoelastic was dried in the device.The plunger was advanced just beyond mid-nozzle.The photo was too blurry in order to determine if the clear lens model was present in the device.The nozzle tip has a wound guard which allows the tip to be inserted into the incision up to the connection point of the wound guard.The tip of the nozzle did not appear to be damaged or unusual.The model of the nozzle could not be identified from this photo, as the posterior view was not shown.A physical sample would be necessary in order to make any further determinations.Product history records were reviewed and the documentation indicated the product met release criteria.Only a blurry anterior view of the device was returned.A review of the product history records indicated that an appropriate nozzle was installed onto the device during manufacturing and the product met release criteria.No nozzle anomalies could be confirmed from the provided photo.The product has not been received to evaluate.A physical sample would be necessary in order to make any further determinations.Due diligence has been performed in an attempt to obtain further information on this event.The reporter has not responded to requests for follow-up information.File will be reopened if new information or the sample is received.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: 21774575
• Report Number: 1119421-2025-00930
• Device Sequence Number: 12780749
• Product Code: KYB
• UDI-Device Identifier: 00380652395311
• UDI-Public: (01)00380652395311(17)270708(11)240709(10)15885365
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 06/14/2025

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: 15885365
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 06/14/2025
• Date Device Manufactured: 07/09/2024
• 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