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 Fold (1255); Failure to Advance (2524); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device 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-healthcare professional reported that before an intraocular lens (iol) implant procedure, when the surgeon was folding the lens, it did not fold correctly.The piston went over the lens and damaged it.There was no patient contact and patient impact.Surgery was completed on same with a unspecified back up lens.Additional information has been requested.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The device with the lens was returned loose in the carton.The plunger lock and the lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was advanced to mid-nozzle and has underrode the lens.The lens was still within the lens loading area, positioned on top of the plunger.The trailing portion of the optic was misfolded under, broken, and torn by the advancing plunger underride.The leading haptic was extended on the plunger.The trailing haptic was broken in the gusset area and positioned to the left in the loading area.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.Qualified viscoelastics were indicated.The root cause for the reported complaint could not be determined.A plunger underride was observed and may have been interpreted as the reported complaint.The lens was still inside the loading area on the plunger.The trailing optic portion was misfolded under, broken, and torn.The trailing haptic was also broken.The plunger advanced to mid-nozzle with the lens still in the loading area may indicate the plunger was advanced too rapidly, resulting in the observed plunger underride.Plunger underride may occur: due to rapid advancement faster than the instructions for use (ifu) recommended rate.If the device is overfilled with ophthalmic viscosurgical device (ovd), this can prevent the trailing haptic from being placed properly or move the lens out of position resulting in misfolding.If the operating room temperature is too high (> 23°c / 73° 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: 22175093
• Report Number: 1119421-2025-01629
• Device Sequence Number: 12717268
• Product Code: HQL
• UDI-Device Identifier: 00380652394628
• UDI-Public: (01)00380652394628(17)251030(11)221101(10)15521316
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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 Expiration Date: 10/30/2025
• Device Model Number: AU00T0
• Device Lot Number: 15521316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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: DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown