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 Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
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 physician reported that during the intraocular lens (iol) implant procedure, the lens was found to be defective under the microscope and therefore it was not implanted.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 lens stop and plunger lock were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was advanced into the nozzle entry area and has under rode the lens.The lens was advanced into the nozzle.The leading haptic was straight.The trailing haptic was misfolded underneath the optic due to the plunger underride.The misfolded haptic was most likely interpreted as the reported 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.Viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.A plunger underride was observed which has resulted in a misfolded trailing haptic.The misfolded trailing haptic appearance was most likely interpreted as the reported complaint.The root cause for the reported complaint cannot be determined.It is unknown if a qualified viscoelastic was used.The ifu (instructions for use) instructs: during device preparation and implantation of the company iol with the company preloaded delivery system, an company qualified ophthalmic viscoelastic device (ovd) should be used.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.Plunger underride may occur: due to rapid advancement faster than the ifu recommended rate.Due to the use of a non-qualified viscoelastic.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.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.Topcoat 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: 22730854
• Report Number: 1119421-2025-02169
• Device Sequence Number: 9144116
• Product Code: HQL
• UDI-Device Identifier: 00380652394727
• UDI-Public: (01)00380652394727(17)280219(11)250220(10)15996735
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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: 15996735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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
• Patient Sex: Unknown