MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CCWTT0
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, first lens was explanted in initial procedure due to scratch along posterior side of iol.Second lens had a torn haptic, explanted, and the third one was successful.The procedure was completed with another iol.There was no patient harm.Additional information was requested.There are two medical device reports associated with this report.This report is about scratch along posterior side of iol.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.Half of the optic was found loose in the bag with the disassembled lens case.The other portion was adhered to the outside of the lens case.Viscoelastic was observed.The optic had been cut across the center.The haptic was broken on one portion (found in the bag).There was a narrow scratch that was across both returned portions of the lens on the anterior surface.This scratch was perpendicular to the travel path.A second shorter narrow scratch was observed on the anterior surface near the edge.This damage was similar in appearance to damage caused by forceps.This damage would not have occurred during lens delivery.Other instrument marks were observed on the edge near the cut mark.These were most likely caused during the removal.Complaint and product history records were reviewed, and documentation indicated the product met release criteria.Qualified associated products were indicated.The root cause may be related to a failure to follow the ifu (instructions for use).There was a narrow scratch that was across both returned portions of the lens on the anterior surface.This scratch was perpendicular to the travel path.A second shorter narrow scratch was observed on the anterior surface near the edge.This damage was similar in appearance to damage caused by forceps.This damage would not have occurred during lens delivery.Inadequate viscoelastic was observed in the returned used cartridge.Top coat dye stain testing was conducted with acceptable results the root cause for the reported damage may be related to a failure to follow the ifu.The ifu instructs to completely fill the cartridge with ovd (ophthalmic viscosurgical device) 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.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.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 alcon.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 (intraocular lens) 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 company 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 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: CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 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: 21167477
• Report Number: 1119421-2025-00180
• Device Sequence Number: 4538454
• Product Code: MFK
• UDI-Device Identifier: 00380652413626
• UDI-Public: (01)00380652413626(17)270730(11)230801(10)15682593
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: CCWTT0
• Device Catalogue Number: CCWTT0.190
• Device Lot Number: 15682593
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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: CLAREON MONARCH IV IOL, INJECTOR; DUOVISC VISCOELASTIC SYSTEM; MONARCH II LOADING FORCEPS; MONARCH III IOL, CARTRIDGE D
• Patient Sex: Unknown