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
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.
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
Additional information provided in d.9., h.3., h.6 and h.11.The device with the lens was returned with the removed plunger.The plunger lock and lens stop have been removed.Viscoelastic was observed in the device.The lens was still in the loading area and showed no signs of advancement.There was no damage observed to the body of the device.The plunger was undamaged.The plunger was reinserted inside the barrel.The plunger did not appear loose once it was reinserted into the device.No plunger anomalies were observed.It is unknown if the qualified product was used.The root cause could not be determined for the reported complaint of "lens jammed".The device with the lens was returned with the plunger removed.The lens was still in the loading area and showed no signs of advancement.It is unknown if the plunger was inadvertently retracted.Per the ifu, do not attempt to retract the plunger after the plunger lock has been removed or plunger damage may result.Retracting the plunger can pull the tabs outside of the barrel and cause the plunger to release from the device.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: 20737791
• Report Number: 1119421-2024-02263
• Device Sequence Number: 15546679
• Product Code: HQL
• UDI-Device Identifier: 00380652395328
• UDI-Public: (01)00380652395328(17)260918(11)230920(10)15718386
• 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: 09/18/2026
• Device Model Number: ACU0T0
• Device Lot Number: 15718386
• 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: 09/20/2023
• 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: ACRYSOF IQ ULTRASERT DELIVERY SYSTEM; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 86 YR
• Patient Sex: Female