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	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, haptic was not in position.The surgery was completed on the same day and there was no patient harm.Additional information has been requested.
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 d.9., h.3., h.6 and h.11.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.No viscoelastic was observed in the nozzle or the tip of the device.Viscoelastic was only observed on/at the area of the lens.The plunger was observed to be retracted back.The lens was advanced to mid-nozzle.The lens was misfolded up against the roof of the nozzle.The leading haptic was misfolded and broken, facing back towards the loading area.The trailing haptic was misfolded with the distal tip extended backwards facing the loading area in the device.The haptic was on top of and extended on the of the retracted plunger.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.It is unknown if the complaint was in regards to the leading haptic or the trailing haptic.The trailing haptic position is not a qualified haptic position per the instructions for use (ifu).The plunger was retracted, which may have resulted in the misfolded, extended trailing haptic.The root cause for the reported complaint may be related to a failure to follow the ifu.Inadequate viscoelastic was observed in the device.No viscoelastic was observed in the nozzle or the tip of the device.Viscoelastic was only observed on or at the area of the lens.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 milliliter(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.The ifu instructs: after the lens has been advanced to the fill-to line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.No part of the lens should exit the nozzle prior to insertion through the incision.Once the lens is in position at the fill-to line, it should be implanted within 3 minutes.Proceeding with implantation of a misfolded haptic or a lens that appears to be out of position can result in a broken haptic or other negative outcome, since the haptic may be trapped and stretched, and or pinched and sheared by the moving plunger.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: 24034493
• Report Number: 1119421-2026-00088
• Device Sequence Number: 9141332
• Product Code: KYB
• UDI-Device Identifier: 00380652395212
• UDI-Public: (01)00380652395212(17)280610(11)250612(10)16053249
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: ACU0T0
• Device Lot Number: 16053249
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• 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