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

Model Number	CNWTT0
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2026
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that during unknown time of an intraocular lens (iol) implant procedure, the lens was torn.
Event or Problem Description
Additional information received and stated that the lens had been replaced on the same day, and the surgery had been completed without harm to the patient.
Additional Manufacturer Narrative
Additional information was provided in b.5., h.3., h.6.And h.11.The product was not returned for analysis.Only photo was returned.The reported complaint can be observed on the returned photo.Photo review: received photo shows an (intraocular lens) iol in a lens case base.The iol is damaged and one haptic is broken torn and not observed.Based on our observation of the attached photo, the iol is damaged and one haptic is broken torn and not observed.A definitive determination of the reported complaint cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• 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: 24290615
• Report Number: 9612169-2026-00272
• Device Sequence Number: 13118271
• Product Code: MFK
• UDI-Device Identifier: 00380652408134
• UDI-Public: (01)00380652408134(17)260717(11)220719(10)25443162
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2026

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 Expiration Date: 07/17/2026
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.205
• Device Lot Number: 25443162
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 04/13/2026; 06/09/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 05/04/2026; 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; UNSPECIFIED INJECTOR.; UNSPECIFIED VISCOELASTIC.
• Patient Sex: Unknown