MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CNWTT0
Medical Device Problem Codes	Break (1069); Optical Decentration (1360); Device Damaged by Another Device (2915); Scratched Material (3020); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Corneal Edema (1791); Intraocular Pressure Increased (1937); Visual Impairment (2138)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A non-healthcare professional reported that during cataract surgery with intraocular lens (iol) implantation, the lens was damaged (by the retractable tip of the injector) and the optical zone was scratched and the haptics were torn off.Patient experienced deterioration in vision and had incorrect optical zone.According to current information the patient is fine.An explant has been planned.According to the additional information received, the patient's lens was cut into 3 pieces using scissors under local anesthesia, followed by explantation of the lens through the original wound.Than a company replacement lens was implanted.Postoperatively there was a slight elevation of intraocular pressure (iop) and edema at the site of the surgical wound.The hospital is currently following up with the patient.
Additional Manufacturer Narrative
The product was returned for analysis and damage was observed to the intraocular lens (iol).No cartridge or handpiece returned.Iol returned in three segments, on a piece of surgical material inside an opened company pouch.Solution is dried on both surfaces of the optic and haptics.One haptic is broken/torn and not returned, the other haptic is intact with loose fibers.The optic is torn/split-cut dividing the iol in three and is scratched/marked rejectable with loose fibers and particulate.We are unable to determine the root cause for the reported complaint "damaged iol during surgery, explant".The lens was returned in three segments.The condition of the returned iol is consistent with lens having been explanted.The file states that lens was damaged by the tip of the injector and the optical zone was scratched and the haptics were torn off.It is unknown if the reporter suspects iol to be the cause of the event.Additional record was initiated for injector but the product was not returned for evaluation.No cartridge was returned.Based on these investigation findings, we are unable to verify if the iol contributed to the event.Based on the results from the product history record, the products met release criteria.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.
Event or Problem Description
Additional information was received on 02-oct-2025, indicating that a crack was observed on the intraocular lens (iol) following implantation.It was reported that the damage occurred due to the injector during the implantation process.Additionally, the lens was found to be decentered.
Additional Manufacturer Narrative
Additional information provided in sections a1, a2, b2, b5, and h6.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 HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19320500
• Report Number: 9612169-2024-00448
• Device Sequence Number: 7659671
• Product Code: MFK
• UDI-Device Identifier: 00380652408172
• UDI-Public: (01)00380652408172(17)260930(11)221002(10)25487304(21)25487304049
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.225
• Device Lot Number: 25487304
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 09/03/2024; 10/02/2025
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 10/02/2024; 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2022
• 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.; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Unknown