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 Code	Dent in Material (2526)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2025
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 physician reported that during an intraocular lens (iol) implant procedure, an uneven iol edge was noticed and surgery was completed with the same lens.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photo and video were returned.The reported complaint was observed on the returned photo and video.Provided photos show an intraocular lens (iol) in a lens case base.The lens is not positioned correctly in the lens case base well, the lens is off the centre, at an angle.The optic appears to be pressed against the posts of the lens case base well.The optic edge appears to be damaged.Provided video shows an iol in a lens case base.The lens case base is being held by a person.The lens is not positioned correctly in the lens case base well, the lens is off the centre, at an angle.The optic appears to be pressed against the posts of the lens case base well.The optic edge appears to be damaged.The complainant indicates the use of rumex as a viscoelastic which is not qualified for use with the associated iol model.Based on our observation of the attached photo/video, the optic edge appears to be damaged.The origin of the observed damage cannot be confirmed based on the returned photos/video alone and without evaluating 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).

• 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: 23390701
• Report Number: 9612169-2025-02148
• Device Sequence Number: 13274930
• Product Code: POE
• UDI-Device Identifier: 00380652405263
• UDI-Public: (01)00380652405263(17)280908(11)240910(10)25920565
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: CNWET0.210
• Device Lot Number: 25920565
• 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: 10/27/2025
• Supplement Report FDA Received Date: 01/06/2026
• Date Device Manufactured: 09/10/2024
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C.; RUMEX VISCOELASTIC.
• Patient Age: 79 YR
• Patient Sex: Unknown