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

Model Number	ACU0T0
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that unfortunately the iol did not work.The procedure was completed by using company another lens of same model and diopter.
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 b.5., d.9., h.3., h.6.And h.11.The device with the lens was returned loose in the carton.The lens stop was removed and not returned.The plunger lock was intact upon return.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was located at the start position upon return.The lens door was slightly ajar.The door lock, lack, and hinge were undamaged.The lens door closed and locked securely.The lens was inside the loading area.The trailing haptic was slightly raised upon return.No damage was observed to the device.Product history records were reviewed, and the documentation indicated the product met release criteria.Viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The product investigation could not identify the root cause for the reported complaint of "the plunger did not push the intraocular lens (iol) forward".The device was returned with steps of preparation already completed.The plunger was located at the start position upon return.Viscoelastic was present in the device.The lens stop was removed.Upon return, the lens door was slightly ajar.No damage was observed to the door or components.It is unknown if the lens had been removed from the device to inspect and then replaced.The lens door latch and hinge worked correctly and were undamaged.It is unknown if the lens stop was removed incorrectly during preparation.This could potentially allow the lens door to be forcibly unlocked.Per the instructions for use (ifu): remove the blue colored lens stop by gripping the arrow tab portion and bending it forward slightly while lifting up and away from the device.It is unknown if a qualified viscoelastic was used.The ifu instructs: during device preparation and implantation of the company iol with the company preloaded delivery system, a company qualified ophthalmic viscoelastic device (ovd) should be used.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stating that the plunger did not push the (intraocular lens) iol forward.

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• 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: 21716031
• Report Number: 1119421-2025-00858
• Device Sequence Number: 20019950
• Product Code: HQL
• UDI-Device Identifier: 00380652395359
• UDI-Public: (01)00380652395359(17)270505(11)240506(10)15851563
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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: 15851563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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