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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported with a description of lens mechanical breakdown.Additional information has been received and stated as patient had no improvement in eye after initial surgery.Surgeon stated that the initial iol was removed and replaced with basic iol and the symptoms were resolved after the explant.In surgeon opinion mechanical breakdown contributed to poor vision.
Additional Manufacturer Narrative
The product was returned for analysis.Intraocular lens (iol) returned wrapped in surgical gauze.Solution is dried on the iol.Both haptics are intact.The optic is scratched or marked rejectable.The reported complaint cannot be confirmed from the returned sample the reporter stated the company iol was replaced with another model company iol.The root cause for the reported complaint could not be determined.The exchange to a monofocal lens may suggest that the replacement lens model was an improved choice for the patient's vision needs.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: 21405333
• Report Number: 9612169-2025-00232
• Device Sequence Number: 13089314
• Product Code: POE
• UDI-Device Identifier: 00380652405287
• UDI-Public: (01)00380652405287(17)260907(11)220909(10)25487992
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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 Expiration Date: 09/07/2026
• Device Model Number: CNWET0
• Device Catalogue Number: CNWET0.220
• Device Lot Number: 25487992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2022
• 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 ASPHERIC HYDROPHOBIC ACRYLIC IOL.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Age: 69 YR
• Patient Sex: Female