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	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
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 lens was not unfolding as expected with no patient contact.The procedure was completed on same day by another unspecified lens without any harm to the patient.Additional information has been requested, but no further information available.
Additional Manufacturer Narrative
Additional information has been provided in d.9.,h.3., h.6., and h.11.The device with the lens was returned in the blister tray in the carton.The lens stop and plunger lock were removed.The plunger was oriented correctly.Inadequate viscoelastic was observed in the device.The plunger has advanced the lens to the fill line and has underrode the right side of the optic.Both haptics were folded onto the anterior optic surface.The right side of the optic was misfolded up due to the plunger underride.This was most likely interpreted as the complaint.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Top coat 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 used.A plunger underride was observed.The lens was misfolded at the fill line due to the plunger underride.This was most likely interpreted as the reported compliant.The root cause was most likely due to a failure to follow the ifu (instructions for use).An inadequate amount of viscoelastic was observed in the device.The ifu instructs: fully insert the ovd (ophthalmic viscosurgical device) cannula, perpendicular to the device, through the viscoelastic port, located in the lens stop portion of the device.Fill the device until ovd can be observed flowing to the ¿fill-to¿ line on the nozzle tip.This will require approximately 0.2 ml of ovd.Only use an alcon ovd qualified for use with the ultrasert¿ pre-loaded delivery system that has been allowed to come to the operating room temperature.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.Plunger underride may occur: due to rapid advancement faster than the ifu 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 advance incorrectly or become ¿stuck¿ in the device allowing the plunger to underride the lens.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.Top coat dye stain testing was conducted with acceptable results.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: 23347017
• Report Number: 1119421-2025-02727
• Device Sequence Number: 18527790
• Product Code: HQL
• UDI-Device Identifier: 00380652394642
• UDI-Public: (01)00380652394642(17)261125(11)231127(10)15756758
• 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): 11/28/2025

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: AU00T0
• Device Lot Number: 15756758
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• 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.
• Patient Sex: Unknown