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

Model Number	AU00T0
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A clinician reported that during an intraocular lens (iol) implant procedure, the plunger was primed and depressed; however, it exhibited no resistance.As a result, the lens adhered to the plunger and remained visible within the cartridge.Upon insertion, the lens wouldn't sit correctly and was subsequently removed during the initial procedure.The procedure was completed with the replacement lens on the same day.
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 was returned loose in the carton.The plunger lock and lens stop have been removed from the device.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was advanced outside the nozzle tip.No damage or abnormalities observed to the returned device.The lens was returned outside the device inside a specimen cup.One haptic was broken in the distal tip area (not returned).The optic was cut from edge past center, typical of insertion and removal.The provided photo appears to be of the returned product.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.The product investigation could not identify a root cause for the reported complaint.No damage, abnormalities, or issues observed to the returned device.The lens was returned outside the device inside a specimen cup.One haptic was broken in the distal tip area.The optic was cut from edge past center, typical of insertion and removal.The ifu (instructions for use) instructs: take at least 7 seconds to gently fold the iol(intraocular lens) by advancing the plunger forward in one smooth, continuous motion until the front edge of the optic is even with the ¿fill-to¿ line on the nozzle.Do not allow any portion of the lens to exit the nozzle tip.At this position the blue spring will contact the clear main body.It is important to not advance the plunger abruptly to fold the iol as improper folding and lens damage may occur.The ifu instructs: after the lens has been advanced to the nozzle 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.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.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 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: 23497966
• Report Number: 1119421-2025-02880
• Device Sequence Number: 9037988
• Product Code: HQL
• UDI-Device Identifier: 00380652394826
• UDI-Public: (01)00380652394826(17)280419(11)250421(10)16029850
• 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): 01/12/2026

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: 16029850
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/12/2026
• Date Device Manufactured: 04/21/2025
• 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 OVD.
• Patient Sex: Unknown