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

Model Number	CNWTT0
Medical Device Problem Codes	Particulates (1451); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.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
A health care professional reported that after intraocular lens implantation procedure, during examination some particle¿s structure and crack like structure was noticed in the optic of the lens.The patient's immediate post-op was 6/9, and it was affecting the vision.As per the surgeon's opinion it was a lens burst due to which the patient did not received any desired outcomes.Hence the surgeon planned to do an explant of the lens.The current patient condition was symptoms still continuing.
Additional Manufacturer Narrative
Additional information was provided in h.6.And h.11.The product was not returned for analysis.Only photo was returned.The reported crack and particles cannot be confirmed from the returned photo.Provided photo shows an implanted intra ocular lens (iol).There appear to be white marks on/over the lens and light reflections.The reported crack and particles cannot be confirmed from the returned photo.The complainant indicates the use of epsilon shooter and non-company ophthalmic viscosurgical device (ovd) which are not qualified for use with the associated iol model.The ot temperature was reported as 24 degrees.Based on our observation of the attached photo, there appear to be white marks on/over the lens and light reflections.The reported crack and foreign particles cannot be confirmed from the returned photo.The origin of the observed marks cannot be confirmed based on the returned photo alone and without evaluating the physical product.The root cause of the reported events cannot be determined.The surgeon states the use of non-qualified injector and viscoelastic.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.Also, the ot temperature was reported as 24 degrees.Company instructions for use (ifu) instructs: use the company cartridge at operating room temperatures between 18° c (64 degree f) and 23° c (73 degree f).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.
Additional Manufacturer Narrative
The product was not returned for analysis.Only photo was returned.The reported crack and particles cannot be confirmed from the returned photo.Provided photo shows an implanted iol.There appear to be white marks on/over the lens and light reflections.The reported crack and particles cannot be confirmed from the returned photo.The complainant indicates the use of non company shooter and non company ovd which are not qualified for use with the associated iol model.The ot temperature was reported as 24 degrees.Based on our observation of the attached photo, there appear to be white marks on/over the lens and light reflections.The reported crack and foreign particles cannot be confirmed from the returned photo.The origin of the observed marks cannot be confirmed based on the returned photo alone and without evaluating the physical product.However, based on the information provided by the customer, the most likely root cause is failure to follow ifu, as the surgeon states the use of non-qualified handpiece and viscoelastic.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.The ot temperature was reported as 24 degrees.Company ifu instructs: use the company cartridge at operating room temperatures between 18° c (64° f) and 23° c (73° f).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.

• 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: 23452757
• Report Number: 9612169-2025-02194
• Device Sequence Number: 18394285
• Product Code: MFK
• UDI-Device Identifier: 00380652408103
• UDI-Public: (01)00380652408103(17)270609(11)230611(10)25653418
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2026

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: CNWTT0.190
• Device Lot Number: 25653418
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 02/16/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 01/12/2026; 03/11/2026
• Date Device Manufactured: 06/11/2023
• 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: AUROVISC OVD.; EPSILON SHOOTER.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C.
• Patient Sex: Male