MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	ACU0T0
Medical Device Problem Codes	Failure to Deliver (2338); Failure to Eject (4010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during an intraocular lens (iol) implant procedure, the lens was implanted into the eye when the doctor was positioning the lens and noticed a scratch.The lens was removed.The second and third lens were jammed in the cartridge.The fourth lens was implanted successfully.
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).H10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.Only the used device was returned.The lens stop and plunger lock were removed.The plunger was oriented correctly.Viscoelastic was observed in the cartridge.The plunger was retracted into the loading area.The lens was not returned.Product history records were reviewed and documentation indicated the product met release criteria.A qualified viscoelastic was used.The root cause cannot be determined for the reported complaint of lens jammed.Only the used device was returned.The plunger was retracted into the loading area.The condition of lens jammed was not observed.Due to the absence of the lens from the used device, it cannot be confirmed from the product evaluation if the reported delivery difficulty of lens jammed occurred.Lens may become stuck in the device if the operating room temperature is too high (> 23 degree celsius / 73 degree fahrenheit) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.File will be reopened if new information is provided.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20736212
• Report Number: 1119421-2024-02264
• Device Sequence Number: 18296266
• Product Code: HQL
• UDI-Device Identifier: 00380652395328
• UDI-Public: (01)00380652395328(17)261004(11)231006(10)15725586
• 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): 02/12/2025

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: 10/04/2026
• Device Model Number: ACU0T0
• Device Lot Number: 15725586
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2023
• 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 OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 86 YR
• Patient Sex: Female