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); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device 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 health care professional reported that during an intraocular lens (iol) implant procedure, while injector was pushed through on the company cartridge, the lens haptic was pinched and damaged.The iol got stuck in the cartridge nozzle before being inserted into the anterior chamber of the eye.Due to damage, the lens was not implanted.There was no patient contact.The surgery was completed without iol implantation.The patient remained aphakic and stayed in the hospital for observation and in a subsequent procedure, implantation of the unspecified appropriate iol was done.There was no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Correction information provided in d.10.(unspecified ophthalmic viscosurgical device was inadvertently captured in the initial mdr submitted).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
Additional information 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.The first photo showed the carton endcap.The second photo showed a yellow lens model in a piece of a cartridge nozzle.The nozzle had been cut off from the rest of the cartridge.The tip of the nozzle had also been cut off.Lens appeared to be folded correctly.However, we are unable to determine if there was haptic damage.A physical sample would be necessary to make further determinations.It cannot be determined if the cartridge was placed into a handpiece.Viscoelastic amount cannot be verified.The complainant indicates the use of apavisk as a viscoelastic which is not qualified for use with the associated iol model.The reported complaint cannot be confirmed from the returned photo, however, based on the information provided by the customer, the most likely root cause is failure to follow instructions for use (ifu), as the surgeon states the use of non-qualified viscoelastic.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 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: 23671211
• Report Number: 9612169-2025-02371
• Device Sequence Number: 18612307
• Product Code: MFK
• UDI-Device Identifier: 00380652408011
• UDI-Public: (01)00380652408011(17)280211(11)240213(10)25794910
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.145
• Device Lot Number: 25794910
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 12/16/2025; 01/27/2026
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 01/07/2026; 02/14/2026
• Date Device Manufactured: 02/13/2024
• 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: APAVISK.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; UNSPECIFIED INJECTOR.; UNSPECIFIED OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown