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

Model Number	CNWTT0
Medical Device Problem Codes	Break (1069); Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/02/2025
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 non-healthcare professional reported that during an intraocular lens (iol) implant procedure, lens was damage by company handpiece injector.Haptic was broken or torn or missing.Scratch or mark on optic or blemish or indentation or scuff mark or score mark on optic was observed.Additional information has been requested.
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 was observed on the returned photo.Provided photo shows an iol (intraocular lens) sitting on the edge of the lens case base, outside of the well.One haptic appears to be bent and the tip of the haptic appears to be touching the optic edge.The other haptic appears to be broken/deformed.The optic edge and surface appear to be damaged.It is stated in the file that "lenses were damaged at implant time, routinely loaded, viscoelastic cartridge used and company iv injector used." based on our observation of the attached photo, the lens appears to be damaged.The origin of the observed damage cannot be confirmed based on the returned photo alone and without evaluating the physical product.The product was subject to handling and the reported damage was highlighted at implant time, after loading into cartridge.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).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: 23402370
• Report Number: 9612169-2025-02159
• Device Sequence Number: 10047907
• Product Code: MFK
• UDI-Device Identifier: 00380652408202
• UDI-Public: (01)00380652408202(17)290105(11)250107(10)25964378
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: CNWTT0.240
• Device Lot Number: 25964378
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/08/2026
• Date Device Manufactured: 01/07/2025
• 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.
• Patient Sex: Male