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 Code	Failure to Eject (4010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device with the lens was returned in the blister tray in the carton.The plunger lock and the lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted to the starting point of the loading area.The lens was slightly advanced forward inside the lens loading area.The leading haptic was ahead of the optic.The trailing haptic was folded toward the optic with the distal haptic tip placed on the optic surface.The plunger was removed from the device and evaluated.There was no damage observed to the plunger.The plunger was reinserted into the device with no difficulties observed.Product history records were reviewed and documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The root cause for the reported complaint cannot be determined.The lens only slightly advanced, still in the loading area.The trailing haptic was folded toward the optic with the distal haptic tip placed onto the optic.There appeared to have been adequate viscoelastic added into the device.Upon return, the plunger was retracted to the starting point of the loading area.It is not possible to confirm the position of the plunger in relation to the lens prior to the retraction of the plunger.The plunger was removed and evaluated.There was no damage observed to the plunger.The plunger was reinserted into the device with no difficulties.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
An inventory coordinator reported that during intraocular lens implant procedure, the plunger would not engage.There was patient contact with the product.No information was provided related to patient harm.

• 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: 17074258
• Report Number: 1119421-2023-01056
• Device Sequence Number: 6130236
• Product Code: HQL
• UDI-Device Identifier: 00380652395250
• UDI-Public: 00380652395250
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2023

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: 10/05/2025
• Device Model Number: ACU0T0
• Device Lot Number: 15505405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• 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: DUOVISC VISCOELASTIC SYSTEM
• Patient Age: 78 YR
• Patient Sex: Male