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

Model Number	CNWTT0
Medical Device Problem Codes	Failure to Deliver (2338); Dent in Material (2526)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during intraocular lens implantation surgery, the lens was chipped on the md peripheral central rings and the physician couldn't insert the lens with a 2.2 incision and it felt stuck in the company injector.So, they removed and noticed that the lens was chipped.The procedure was completed on the same day with unspecified replacement lens.Additional information has been requested.
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.Provided photo shows an iol sitting on the lens case base, outside of the well.The reported damage to the lens cannot be confirmed from the returned photo.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information has been provided in h.3., h.6., and h.11.The product was not returned for analysis.Only photo was returned.The reported complaint cannot be confirmed from the returned photo.Provided photo shows an iol (intraocular lens) sitting on the lens case lid.The reported damage to the lens cannot be confirmed from the returned photo due to the quality of the photo.We cannot confirm the reported event based on the returned photo and without the evaluation of the physical product.The reported complaint cannot be confirmed from the provided photo.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).
Additional Manufacturer Narrative
Additional information has been provided in d.9., h.3., h.6., and h.11.The product was returned for analysis and damage was observed to the iol (intraocular lens).No cartridge was returned.Iol returned posterior surface up instead of anterior surface up in the iol case.Substantial amount of solution is dried on the iol.The reported chip cannot be confirmed due to the condition of the sample.The sample was cleaned for further evaluation.There are a few deep scratches and fractures in the optic, which could be interpreted as the reported chip.There are marks on the haptics.The iol met specifications when dimensionally measured for edge thickness and plan view.Provided photo shows an iol sitting on the lens case lid.The reported damage to the lens cannot be confirmed from the returned photo due to the quality of the photo.We are unable to determine the root cause for the reported complaint lens stuck in the injector and it was chipped.There are a few deep scratches and fractures in the optic, which could be interpreted as the reported chip.The reported damage was observed when the iol was removed from the cartridge.No cartridge was returned; due to this, we are unable to complete a thorough investigation to determine a root cause.In addition to this, all iols are 100 percent cosmetically inspected as per approved manufacturing procedures and the observed lens condition would not meet our current release criteria.The iol met specifications when dimensionally measured for edge thickness and plan view.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).

• 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: 22036873
• Report Number: 9612169-2025-01068
• Device Sequence Number: 8112209
• Product Code: MFK
• UDI-Device Identifier: 00380652408165
• UDI-Public: (01)00380652408165(17)280926(11)240928(10)25897894
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2025

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: CNWTT0.220
• Device Lot Number: 25897894
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 11/19/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/01/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2024
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; UNSPECIFIED LENS
• Patient Sex: Female