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

Model Number	AU00T0
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned loose in the carton.The plunger lock and lens stop were removed.No damage was observed to the door or door lock.The nozzle was returned separated from the device.There was no visual evidence that the nozzle was fully seated during manufacturing.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 non-qualified viscoelastic was indicated.The root cause was determined to be manufacturing related.The product was returned.The nozzle was separated from the device.There was no visual evidence that the nozzle was fully seated during the manufacturing process.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A pharmacist reported that during cataract surgery with an intraocular lens (iol) implant procedure, the injector tip was unstable and detaches/falls off during use.The surgery was completed during the same procedure, used another implant.The medical device didn't touch the patient's eye.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The device was returned loose in the carton.The plunger lock and lens stop were removed.No damage was observed to the door or door lock.The nozzle was returned separated from the device.There was no visual evidence that the nozzle was fully seated during manufacturing.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 non-qualified viscoelastic was indicated.The root cause was determined to be manufacturing related.The product was returned.The nozzle was separated from the device.There was no visual evidence that the nozzle was fully seated during the manufacturing process.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH 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: 23323093
• Report Number: 1119421-2025-02714
• Device Sequence Number: 13248969
• Product Code: KYB
• UDI-Device Identifier: 00380652394888
• UDI-Public: (01)00380652394888(17)280330(11)250401(10)16017217
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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: 16017217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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: VISCOELASTIC SOLUTION USED : IXIUM TWIN.
• Patient Age: 74 YR
• Patient Sex: Unknown