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	Device Difficult to Setup or Prepare (1487); Failure to Prime (1492); Failure to Deliver (2338); Failure to Advance (2524); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A healthcare professional reported that during the intraocular lens (iol) implant procedure, the lens was stuck in injector.Additional information has been received that there was no patient contact.Additional information received that iol became wedged between plunger and injection cannula.In surgeon¿s opinion the increased resistance when pressed the plunger and stopped when noticed the iol/plunger mishap was the cause of the event.
Additional Manufacturer Narrative
Corrected information provided in h.6.Correction: on initial mdr the product problem code a0502 was submitted.Additional information provided in a.2., a.4., b.5.And h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received that there was patient contact with the device.

• 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: 22731095
• Report Number: 1119421-2025-02170
• Device Sequence Number: 13047460
• Product Code: KYB
• UDI-Device Identifier: 00380652395250
• UDI-Public: (01)00380652395250(17)260725(11)230727(10)15685502
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 09/12/2025

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 Expiration Date: 07/25/2026
• Device Model Number: ACU0T0
• Device Lot Number: 15685502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/12/2025
• Date Device Manufactured: 07/27/2023
• 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: PROVISC.
• Patient Sex: Unknown