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

Model Number	CCWET5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurry vision/difficulty with vision, cannot read well and having trouble with intermediate vision.The lens was explanted in a secondary procedure with monofocal lens.The clinical reason for the explant was patient was only correctable to distance 20/30, intermediate 20/40.Reading jio.Additional information has been requested.There are two medical device reports associated with this patient.This report is one of two.
Event or Problem Description
Additional information was requested and received stating a 16.5 toric diopter lens was exchanged for a 17.5 diopter toric lens due to blurry vision/difficulty with vision, cannot read well and trouble with intermediate.This does not meet criteria for reporting based on applicable medical device regulations.A lens exchange from one power to a different power is an attempt to adjust or fine tune the refractive outcome trying to achieve a desired target when the initial lens calculations did not achieve the intended outcome.There is no reported defect or fault with the lens.In the surgeon's opinion, product did not cause or contribute to the event and patient has other ocular diagnosis has suspected the cause.
Additional Manufacturer Narrative
Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING 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: 16868690
• Report Number: 9612169-2023-00347
• Device Sequence Number: 6099971
• Product Code: MJP
• UDI-Device Identifier: 00380652455930
• UDI-Public: 00380652455930
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2025
• Device Model Number: CCWET5
• Device Catalogue Number: CCWET5.165
• Device Lot Number: 25298433
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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: REPLACEMENT LENS: UNSPECIFIED TORIC MONOFOCAL LENS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown