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

Model Number	CNWTT3
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A healthcare professional reported that during an intraocular lens (iol) implant procedure, lens damaged by handpiece injector.At the time of implantation, the intraocular lens found resistance at the exit of the intraocular lens.Lens was stuck in the cartridge and only half of the lens entered the anterior chamber.Therefore, decided to remove the intraocular lens and noticed after the extraction that lens was a little damaged (scratched) then immediately decided to replace that intraocular lens with a new one.Additional information has been requested and received stating that the procedure was completed on same day.The patient was progressing excellently on their third postoperative day.
Additional Manufacturer Narrative
Additional information was provided in d9, h.3., h.6.And h.11.The product was returned for analysis, and the reported complaint was observed.Iol returned posterior surface up instead of anterior surface up in the iol case.The lens is positioned at an angle in the lens case base well, the lens is pressed against a post of the lens case base well.Solution is dried on the iol.The haptics are deformed.The optic is deformed.There are cracks in the optic edge.Sample was cleaned for further evaluation.There are fractures and scratches in the optic.The iol met specifications when dimensionally measured for edge thickness and plan view.A product history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Additional information: the complainant indicates the use of optheis pro as a viscoelastic, which is not qualified for use with associated model, this is not a qualified company product combination.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.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 combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.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 TORIC TRIFOCAL HYDROPHOBIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 24329570
• Report Number: 9612169-2026-00311
• Device Sequence Number: 21279661
• Product Code: MJP
• UDI-Device Identifier: 00380652468534
• UDI-Public: (01)00380652468534(17)281120(11)241122(10)25960905
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: CNWTT3
• Device Catalogue Number: CNWTT3.200
• Device Lot Number: 25960905
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• 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: CENTURION VISION SYSTEM.; CLAREON MONARCH IV IOL DELIVERY SYSTEM INJECTOR.; OPTHEIS PRO VISCOELASTIC.; UNSPECIFIED CARTRIDGE.
• Patient Age: 59 YR
• Patient Sex: Female