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

Model Number	CNWTT0
Medical Device Problem Codes	Break (1069); Optical Decentration (1360)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 physician reported that during an intraocular lens (iol) implant procedure, a crack was found in the leading haptic and the center portion was shifted.The lens remains in the patient eye and there was no harm to the patient.Additional information was received and stated, the central portion of the iol is decentered.The patient visual acuity was good and the patient will be followed up.
Additional Manufacturer Narrative
The lens was not returned.Two videos were provided.The cataract removal was shown.The lens and cartridge preparation was not shown.The lens loading and initial advancement was not shown.The cataract removal took over five minutes.The cartridge tip came into view as it was inserted into the incision at 5:27.The yellow single-piece lens was advanced to parting line.Both haptics were tucked in the optic fold.The lens was advanced into the eye.Fold lines were observed, which may indicate the lens was folded for an extended period of time.The multifocal lens unfolded.The lens was positioned and irrigation and aspiration (i/a) was conducted.The lens was shifted to the left.The video ended.The second video started with a view of the off-center implanted multifocal, single-piece lens.The lens was manipulated with an i/a tip and a cannula tip.One haptic appeared to be cracked-gusset area, still attached.The video ended.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 handpiece and cartridge were used with a non-qualified viscoelastic.The root cause may be related to a failure to follow the instruction for use (ifu).A non-qualified viscoelastic was indicated.The ifu instructs: company foldable intra ocular lens (iols) are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an 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 lens remains implanted.Two videos were provided.The lens and cartridge preparation was not shown.The lens loading and initial advancement was not shown.The cataract removal took over five minutes.It is unknown when the lens loaded.After the lens was delivered fold lines were observed.This may indicate the lens was loaded for an extend period of time.The lens was slightly off-center, shifted to the left.The second video showed what appeared to be a crack at the gusset are with the haptic still attached.Fold lines may occur when the lens is advanced too rapidly, when the or room temperature is too cold, or if inadequate viscoelastic was placed in the device.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.The ifu instructs: follow the section regarding directions for use for information on the maximum allowed time for the intra ocular lens (iol) to stay in the folded condition.Failure to adhere to manufacturer 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.Information was provided that the patient is reportedly doing well both currently and postoperatively.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received and stated, the patient was reportedly doing well both currently and postoperatively.

• Brand Name: CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL 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: 24453558
• Report Number: 1119421-2026-00388
• Device Sequence Number: 15771354
• Product Code: MFK
• UDI-Device Identifier: 00380652408134
• UDI-Public: (01)00380652408134(17)280526(11)240528(10)15862167
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: CNWTT0
• Device Catalogue Number: CNWTT0.205
• Device Lot Number: 15862167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/06/2026
• Date Device Manufactured: 05/28/2024
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH IOL DELIVERY SYSTEM, CARTRIDGE; OPELEAD OPHTHALMIC VISCOELASTIC DEVICE
• Patient Age: 60 YR
• Patient Sex: Male