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	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/15/2025
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 health care professional reported that during surgery while trying to load the lens, the blue plunger did not engage with the lens within the pre-loaded delivery system, whilst the blue plunger did advance, the lens remained in the body of the delivery system.The surgery was able to continue by a new unspecified lens of the same diopter.Additional information has been requested.
Additional Manufacturer Narrative
The device with the lens was returned loose in a plastic bag.The plunger lock and lens stop have been removed.The plunger was oriented correctly.No viscoelastic was observed in the loading area or nozzle entry area.Only a very small amount of viscoelastic was observed in the nozzle tip only.The plunger and lens were advanced to mid nozzle.The lens was in an acceptable folded position.The plunger has slightly overrode a trailing portion of the optic edge.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was indicated.A plunger override was observed.The root cause appears be related to a failure to follow the instructions for use (ifu).No viscoelastic was observed in the loading area or nozzle entry area.Only a very small amount of viscoelastic was observed in the nozzle tip only.The ifu instructs: fill the device until viscoelastic can be observed flowing to the line on the nozzle tip.This will require approximately 0.2 ml of viscoelastic.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become stuck in the device.Only use an company ophthalmic viscosurgical device (ovd) qualified for use with the company pre loaded delivery system that has been allowed to come to the operating room temperature.Plunger override may occur: due to rapid advancement faster than the ifu recommend rate.If inadequate viscoelastic is placed in the device, this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become stuck in the device allowing the plunger to underride the lens.If the operating room temperature is too high (more than 23 degree c or 73 degree f) 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.Due diligence has been performed in an attempt to obtain further information on this event.File will be reopened if new information 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: 21664447
• Report Number: 1119421-2025-00782
• Device Sequence Number: 7614507
• Product Code: KYB
• UDI-Device Identifier: 00380652395311
• UDI-Public: (01)00380652395311(17)270506(11)240507(10)15851507
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: 15851507
• 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: 02/24/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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