MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNWET3
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported following an intraocular lens (iol) implant procedure, the patient experienced nighttime glare and halos.The lens was explanted and replaced with other lens in a secondary procedure.The clinical reason for the explant was lens slightly rotated.Additional information was requested and received stating the intolerance of edof optics due to larger scotopic pupil size was the cause of the event.
Additional Manufacturer Narrative
A sample device 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).

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 16815012
• Report Number: 9612169-2023-00321
• Device Sequence Number: 5695261
• Product Code: MJP
• UDI-Device Identifier: 00380652466295
• UDI-Public: 00380652466295
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2026
• Device Model Number: CNWET3
• Device Catalogue Number: CNWET3.130
• Device Lot Number: 25341982
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2022
• 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 PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female