MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CNWET0
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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).
Event or Problem Description
A non-healthcare professional reported during an intraocular implant lens procedure, lens was detected as damaged and defective.Additional information has been received and stated that, the lens was clamped due to an incorrect position in the container and during advancing an iol into the cartridge at the stage of implantation a defect in the haptic element was revealed.
Additional Manufacturer Narrative
The product was not returned for analysis.Only photo was returned.The reported complaint defect in the haptic element can be observed on the returned photo.Photo provided shows an intra ocular lens (iol) in a lens case base.The iol appears to be positioned incorrectly and is pushed against two of the lens case posts.One haptic is broken/torn and is visible on top of the optic.Based on our observation of the attached photo, the iol appears to be positioned incorrectly in a lens case base and is pushed against two of the lens case posts.One haptic is broken/torn and is visible on top of the optic.The product was subject to handling and it was reported that the iol was loaded into a cartridge.We are unable to confirm that the lens was position incorrectly in the lens case when opened prior to loading into the cartridge.A definitive determination of the reported complaint 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).

• Brand Name: CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• 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: 23617428
• Report Number: 9612169-2025-02321
• Device Sequence Number: 15961910
• Product Code: POE
• UDI-Device Identifier: 00380652405300
• UDI-Public: (01)00380652405300(17)280821(11)240823(10)25897908
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: CNWET0
• Device Catalogue Number: CNWET0.230
• Device Lot Number: 25897908
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 02/13/2026
• Date Device Manufactured: 08/23/2024
• 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; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Patient Age: 49 YR
• Patient Sex: Unknown