MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CCWET0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Headache (1880)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-health care professional reported following the intraocular lens implantation the patient had experienced swollen and puffy eyes and headaches.Additional information has been requested and received stating symptoms are continuing, seeing allergist to do patch testing.There are two medical device reports associated with this event.This is 2 of 2.
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.There have been one other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING 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: 16476271
• Report Number: 9612169-2023-00181
• Device Sequence Number: 7325964
• Product Code: POE
• UDI-Device Identifier: 00380652405690
• UDI-Public: 00380652405690
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2023

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: 03/28/2025
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.160
• Device Lot Number: 25289904
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female