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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
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.Photos were provided.Photo one showed an upside down image of the end cap of the carton which displayed the product information.The used device was placed on the carton in the photo.The device as shown from thumb push of the plunger to mid nozzle.The lens stop and plunger lock were removed.The plunger was oriented correctly.The trailing haptic appeared to be extended backward over the plunger at mid nozzle.It cannot be confirmed if viscoelastic was present in the device.Photo two displayed the used device anterior surface, from mid barrel throughout the tip the lens was advanced to mid nozzle.There appears to be viscoelastic in the device.The image is blurry upon magnification.The plunger tip appears to be in contact with the optic trailing edge.The trailing haptic was mispositioned, extended straight backward with the distal haptic portion extended over top the advancing plunger.The distal haptic tip appeared to be positioned on the right side of the plunger.The leading haptic position and condition cannot be determined from this image.A physical sample would be necessary in order to make final determinations.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during an intraocular lens(iol) implant procedure during injection the trailing haptic unfolded and was straight inside the cartridge.There was a patient contact.The procedure was completed with another lens.There was no patient harm.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 loose in the carton.Lens stop and plunger lock were removed.The plunger was oriented correctly upon return.Viscoelastic was observed in the device.The plunger has advanced the lens to the fill line and was in contact with the trailing optic edge.The optic was folded correctly.The leading haptic was in an acceptable question mark shape in the nozzle tip.The trailing haptic was extended backward and on top of the plunger to mid nozzle.A photo was provided that matched the product.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was used.The root cause could not be determined for the reported complaint.The trailing haptic was extended backward on top of the plunger.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.The trailing haptic may become stuck if the plunger is not fully advanced the haptic may not release properly from the device if the operating room temperature is too high (more than 23 degree or 73 degree f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.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 ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• 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: 21677864
• Report Number: 1119421-2025-00801
• Device Sequence Number: 7740381
• Product Code: HQL
• UDI-Device Identifier: 00380652395175
• UDI-Public: (01)00380652395175(17)270404(11)240405(10)15831080
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 04/23/2025

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: ACU0T0
• Device Lot Number: 15831080
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2024
• 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 OVD.
• Patient Sex: Unknown