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	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device 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 nurse reported during an intraocular lens (iol) implant procedure, while inserting the lens the plunger failed to deploy the lens into the patient's eye.As a result, a replacement lens was used.No harm occurred to the patient.Additional information was requested.
Additional Manufacturer Narrative
The device with the lens was returned.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was advanced to mid nozzle and overrode the lens.The lens was partially advanced into the nozzle entry area.The trailing haptic was folded onto the anterior optic surface.The leading haptic was extended along the right side of the plunger.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The root cause cannot be determined for the reported complaint.A plunger override was observed.The plunger was advanced to mid nozzle.The lens was partially advanced into the nozzle entry area.Plunger override may occur due to rapid advancement faster than the ifu recommended rate, if the device is overfilled with ovd this can prevent the trailing haptic from being placed properly or move the lens out of position resulting in misfolding, or if the operating room temperature is too high greater than 23c or 73f lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.Any of the above listed causes alone or in combination may create the reported event.Top coat dye stain testing was conducted with acceptable results.File will be reopened if new information is received.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 ; 8007579780
• MDR Report Key: 22112663
• Report Number: 1119421-2025-01543
• Device Sequence Number: 14480663
• Product Code: KYB
• UDI-Device Identifier: 00380652394802
• UDI-Public: (01)00380652394802(17)270902(11)240903(10)15913605
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: AU00T0
• Device Lot Number: 15913605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/29/2025
• Date Device Manufactured: 09/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROVISC OVD.
• Patient Sex: Unknown