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 Codes	Failure to Advance (2524); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2025
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 healthcare professional reported that during an intraocular lens (iol) implant procedure, nurse called to report an issue.While implanting the lens using the company injector, the plunger suddenly broke, the lens that was implanted inside the bag and the haptic was cut off.Lens was inside the patient's eye a replacement lens is requested to facilitate explantation and investigation, with the procedure to be scheduled upon receipt of the replacement.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The device with the lens was returned in the blister tray inside the carton.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted prior to the loading area.The lens has been advanced by the plunger into the nozzle tip.A broken haptic was observed in the nozzle tip.The distal haptic of the trailing haptic was broken in two places with the distal haptic tip located on the right side of the device, oriented toward the loading area.The plunger was removed and examined.The plunger was not broken.The plunger was reinserted into the device with no abnormalities observed.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was used.The root cause for the complaint could not be determined.The plunger was not broken.The reported haptic damage was observed.The trailing haptic was broken in two places in the nozzle tip with distal tip oriented toward the loading area.The trailing haptic position may indicate it was not in a proper position for advancement per the provided diagrams in the instructions for use ifu.The ifu instructs: after the lens has been advanced to the fill-to line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.No part of the lens should exit the nozzle prior to insertion through the incision.Once the lens is in position at the fill-to line, it should be implanted within 3 minutes.Proceeding with implantation of a misfolded haptic or a lens that appears to be out of position can result in a broken haptic or other negative outcome, since the haptic may be trapped and stretched, and or pinched and sheared by the moving plunger.Broken haptics may occur: if the operating room temperature is too high less than 23c or 73 fahrenheit lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.In addition, haptic strength modulus decreases as the temperature increases and is more likely to break under stress.If a straight trailing haptic occurs and it was not properly detected to be out of position.If the plunger is not fully advanced, or if the plunger is allowed to retract, the trailing haptic may not release properly from the device.Any of the above listed causes alone or in combination may create the reported event.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: 21394130
• Report Number: 1119421-2025-00430
• Device Sequence Number: 15526784
• Product Code: KYB
• UDI-Device Identifier: 00380652394710
• UDI-Public: (01)00380652394710(17)260605(11)230607(10)15659030
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2025

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: 06/05/2026
• Device Model Number: AU00T0
• Device Lot Number: 15659030
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2023
• 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: DISCOVISC OVD
• Patient Sex: Unknown