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	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Non-healthcare professional reported with a description of lens scratched after implantation.The lens was explanted and replaced with another lens during initial procedure.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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The product was returned for analysis and damage was observed to the intraocular lens (iol).Iol returned positioned incorrectly in the iol case with the optic pressed against the lens case well posts and one haptic adhered to the optic.Solution is dried on the iol.One haptic is bent deformed, the other haptic is bent and adhered to the optic with solution.The optic of the lens is fractured/split-cut almost in two pieces.There is one large scratch and another smaller scratch in the centre of the optic.We are unable to determine the root cause for the reported complaint "lens scratched noted after implantation¿.The iol was returned in three segments, which is consistent with lens having been explanted.The product was subject to handling and the reported damage was highlighted post implantation.We are unable to verify if the product contributed to the event.In addition to this, all iols are 100 percent cosmetically inspected as per approved manufacturing procedures and the observed lens damage/condition would not meet our current release criteria.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: 21512949
• Report Number: 9612169-2025-00313
• Device Sequence Number: 4501683
• Product Code: POE
• UDI-Device Identifier: 00380652405317
• UDI-Public: (01)00380652405317(17)270529(11)230531(10)25653607
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: CNWET0
• Device Catalogue Number: CNWET0.235
• Device Lot Number: 25653607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Sex: Unknown