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	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 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.A photo was provided.The photo showed a company cartridge beside the lens case.A yellow lens was visible advanced to the nozzle entry area.The leading haptic appeared to be extended against the right side.This position may indicate a plunger override occurred.Due to the glare and clarity of the photo no other determination can be made.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 during surgery the plunger went over the intraocular lens (iol) and did not inject it.The surgeon thus switched over to a different injector (company provided injector) and an unspecified lens to complete the surgery.There was no patient harm.
Additional Manufacturer Narrative
Correction in section d.10.Monarch iii iol delivery system injector was not used with the complaint product (sn (b)(6)).It was used with the unspecified backup lens to complete the surgery.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: 24791493
• Report Number: 9612169-2026-00769
• Device Sequence Number: 13265001
• Product Code: MJP
• UDI-Device Identifier: 00380652468763
• UDI-Public: (01)00380652468763(17)260912(11)220914(10)25451910
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 06/22/2026

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: 09/12/2026
• Device Model Number: CNWTT3
• Device Catalogue Number: CNWTT3.330
• Device Lot Number: 25451910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 04/06/2026; 05/27/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 04/30/2026; 06/22/2026
• Date Device Manufactured: 09/14/2022
• 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; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Patient Sex: Unknown