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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
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 non-health care professional reported that during an intraocular lens (iol) implant procedure, there was a faulty lens haptic which was inside the device.There was no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in d.2.,d.4.,d.9.,h.3.,h.6 and h.11.The device with the lens was returned loose inside the carton.The lens stop and plunger lock were removed.The plunger was oriented correctly.An inadequate amount of viscoelastic was observed in the device.The plunger was correctly in contact with the trailing optic edge.The plunger has advanced the lens to mid-nozzle.The leading haptic and the trailing haptic were in acceptable positions per the instructions for use (ifu).The trailing haptic was folded into the optic with the distal tip oriented slightly toward the left inside the folded optic.The trailing haptic position may have been interpreted as the complaint.Product history records were reviewed and documentation indicated the product met release criteria.A qualified viscoelastic was used.The reported faulty lens haptic was not observed.No problems were observed with the returned device.The plunger, lens and haptic positions were acceptable.The trailing haptic position inside the optic fold may have been interpreted as the reported complaint.The trailing haptic position was not a malfunction.This is an acceptable position per the diagram in the ifu.The ifu indicates to proceed with full plunger advancement to fully deliver lens.The evaluation of the sample displayed evidence of inadequate viscoelastic usage which could have been a contributing factor for the trailing haptic position.The manufacturer internal reference number is: (b)(4).

• 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: 22393976
• Report Number: 1119421-2025-01812
• Device Sequence Number: 21099719
• Product Code: KYB
• UDI-Device Identifier: 00380652395281
• UDI-Public: (01)00380652395281(17)270811(11)240812(10)15901961
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: 15901961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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 OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown