MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number	TFNT00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that, lens presented an opacity and a risk point in the central halo, required an explanation of the lens.Additional information has been requested and received stating, when implanting the iol, the doctor noticed an opacity and mark.The lens was then explanted and a new one implanted on the same day.No patient harm.
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.A photo was provided of the removed lens in a specimen container.The lens had been cut into to two pieces.The portions were on top if each other.Both haptics were intact.A dark area was observed near the center of the lens.Unable to determine the nature of the darkened area from the photo.Two brief videos were provided, which showed the lens in a specimen container held by an ungloved hand.The lens pieces were in liquid in the specimen container.The dark area was observed near the center of the lens.Unable to determine the nature of the darkened area from the video.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information has been provided in h.3., h.6., and h.11.The product was not returned.A photo was provided of the removed lens in a specimen container.The lens had been cut into to two pieces.The portions were on top if each other.Both haptics were intact.A dark area was observed near the center of the lens.Unable to determine the nature of the darkened area from the photo.Two brief videos were provided, which showed the lens in a specimen container held by an ungloved hand.The lens pieces were in liquid in the specimen container.The dark area was observed near the center of the lens.Unable to determine the nature of the darkened area from the video.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.A qualified cartridge and handpiece were used with a non-qualified viscoelastic.Based on the photo and short videos, the lens was cut into two pieces, typical of an insertion and removal, and placed into a specimen jar.A dark area was observed on the short video near the optic center; however, it is not possible to determine the nature of the darkened area from the video.It cannot be confirmed if the observed area was the reported opacity or damage.The root cause for the reported complaint may be related to a failure to follow the ifu.A non-qualified viscoelastic was used.The ifu instructs: company foldable iols are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The ifu instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd-filled cartridge.The lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.The ifu instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.Important: the plunger should make initial contact with the cartridge at the ramp.In the event the plunger does not contact the cartridge at the ramp, do not use the handpiece and contact company.The handpiece ifu instructs: verify that the plunger tip is properly engaging the lens optic and that the lens moves forward at the same rate as the plunger while slowly advancing the plunger forward to avoid damaging the lens.When the threads on the knob make contact with the barrel, turn the knob clockwise approximately ½ turn to engage the threads and then stop.The iol will now be in the dwell position.Inspect to ensure the plunger is behind the optic.The ifu instructs: follow the section regarding directions for use for information on the maximum allowed time for the iol to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in iol damage.Ifu note: during lens loading and insertion, do not allow the clareon iol to remain in a folded condition within the selected iol delivery system for more than 3 minutes prior to completing insertion into the capsular bag.The file indicated only the photo/videos were available.Information indicated that when implanting the iol, the doctor noticed an opacity and a risk point in the central halo of the lens.The lens was then explanted and a new one implanted that same day.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• 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: 23041986
• Report Number: 1119421-2025-02467
• Device Sequence Number: 18614431
• Product Code: MFK
• UDI-Device Identifier: 00380652357777
• UDI-Public: (01)00380652357777(17)281208(11)231211(10)15768767
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: TFNT00
• Device Catalogue Number: TFNT00.220
• Device Lot Number: 15768767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/31/2025
• Date Device Manufactured: 12/11/2023
• 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: HEALON.; MONARCH III IOL, CARTRIDGE D.; MONARCH III IOL, INJECTOR.
• Patient Sex: Male