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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	02/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional information has been received from consumer stating he had second opinion.According to him, he was advised to try spectacles with approximately ±2.0 diopter correction, which was also not working some time.Additional information was received and surgeon stated that temporal incision planned to reduce astigmatism.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
A consumer reported that after intraocular lens (iol) implantation surgery, he was suffering from blur vision at all distance.He still has refractive error of +0.50 spherical and -1.5 cylindrical.Additional information has been received from consumer stating he had second opinion.According to him, he was advised to try spectacles with approximately ±2.0 diopter correction, which was also not working some time.
Additional Manufacturer Narrative
Correction: on previous smdr, the method code b14 should have been submitted.Additional information was provided in h3., h6 and h11.The product was not returned for analysis.The root cause for the reported complaint could not be determined.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: 24629711
• Report Number: 9612169-2026-00614
• Device Sequence Number: 15666664
• Product Code: POE
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: CNWET0
• Device Catalogue Number: CNWET0.200
• Device Lot Number: 25920549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2026
• Supplement Date Received by Manufacturer: 03/29/2026; 05/26/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/20/2026; 06/22/2026
• Date Device Manufactured: 10/01/2024
• 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: INTAVISC/ZYONATE; INTAVISC/ZYONATE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male