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	Material Discolored (1170)
Health Effect - Clinical Code	Posterior Capsule Opacification (4807)
Date of Event	07/03/2025
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).
Event or Problem Description
A healthcare professional reported that during an intraocular lens (iol) implant procedure, spikes on the anterior side of the lens.The lens optics had spiculae on their anterior face that completely cover the optics, they were very thin tiny spiculae that appear as on the anterior face of the lens and that are not due to scratches or manipulation.Additional information was received by stating, the patient who underwent cataract surgery in his left eye, one week postoperatively changes in the iol were observed.The patient's visual acuity was 0.2, but the patient had posterior capsule fibrosis, which awaits a capsulotomy.The patient was treated with corticosteroid and quinolone antibiotic.Additional clarification was received by stating, the patient had opacity in his posterior capsule, but in addition, the lens had optical imperfections.
Additional Manufacturer Narrative
The product was not returned for analysis.Only photos were returned.The reported complaint cannot be confirmed from the returned photos.Provided photos show what appears to be close-up images of an implanted lens, although this cannot be determined from the provided photos.There are marks present on the visible surface.We cannot confirm the reported event based on the returned photos and without the evaluation of the physical product.The reported complaint cannot be confirmed from the provided photos.A definitive determination of the reported complaint cannot be made without the evaluation of 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: 22666399
• Report Number: 9612169-2025-01511
• Device Sequence Number: 11681905
• Product Code: POE
• UDI-Device Identifier: 00380652405225
• UDI-Public: (01)00380652405225(17)280516(11)240518(10)25853445
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 10/22/2025

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: CNWET0.190
• Device Lot Number: 25853445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 10/22/2025
• Date Device Manufactured: 05/18/2024
• 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
• Patient Age: 33 YR
• Patient Sex: Male