MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	AU00T0
Medical Device Problem Codes	Failure to Deliver (2338); Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/04/2025
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, they noticed that the plunger got stuck which didn¿t directly affect a patient.Additional information has been requested and received stating that procedure was completed on the same day with the alternate lens.Event occurred following priming as the surgeon was preparing for insertion.The surgeon made contact with the patient eye ready for the implant but was unable to proceed as the lens was stuck in the plunger.Surgeon stated he was unable to move the plunger forward and felt there was a misplacement with the alignment.
Additional Manufacturer Narrative
The device with the lens was returned.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Inadequate viscoelastic was observed in the device.The plunger was advanced to mid-nozzle.The plunger overrode the trailing half of the lens.The trailing half of the lens was misfolded and damaged.The leading haptic was extended.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Topcoat dye stain testing was conducted with acceptable results.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.A qualified viscoelastic was indicated.A plunger override was observed that may have been interpreted as the reported complaint.The root cause may be related to a failure to follow the ifu.Inadequate viscoelastic was observed in the device.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 allowing the plunger to override the lens.Lens may become stuck in the device: ¿ if inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to become ¿stuck¿ in the device ¿ if the operating room temperature is too high (> 23 degree c / 73 degree f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.Plunger override may occur: due to rapid advancement faster than the dfu recommended 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 become ¿stuck¿ in the device if the operating room temperature is too high (> 23 degree c / 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.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH 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: 23952967
• Report Number: 1119421-2026-00026
• Device Sequence Number: 7946275
• Product Code: HQL
• UDI-Device Identifier: 00380652394789
• UDI-Public: (01)00380652394789(17)280625(11)250627(10)16060888
• 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): 02/06/2026

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: 16060888
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/03/2026
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2025
• 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