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	Dry Eye(s) (1814); Visual Disturbances (2140); Unspecified Eye / Vision Problem (4471); Eye Irritation (4803)
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that after cataract surgery with intraocular lens (iol) implantation, he experienced positive dysphotopsia.He also experienced flickering light, sometimes he could see the lens with a bright side light and a dark room, worse indoors with side light, not as bad outside if sunny and pupils were dilated.The vision was worst indoors with ambient light or a room with lots of windows.Consumer also had dry eyes.His right eye developed a stye on the top and the bottom of the lid.The top stye was gone, the bottom was still there.He was not sure if that was related.Consumer reported that since surgeries, it felt like he was wearing hard contact lenses that need to be taken out for relief.He squinted a lot, which felt like it helped with the flickering.The consumer had discussed these concerns with his eye care provider, who advised to wait a year/or take drops to dilate eyes.There are two medical device reports associated with this patient.This report is associated with the right eye.
Additional Manufacturer Narrative
A product 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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 20425490
• Report Number: 9612169-2024-01007
• Device Sequence Number: 8735700
• Product Code: POE
• UDI-Device Identifier: 00380652405652
• UDI-Public: (01)00380652405652(17)250404(11)211111(10)25307300
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2024

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: 04/04/2025
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.140
• Device Lot Number: 25307300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2024
• Initial Report FDA Received Date: 10/11/2024
• Date Device Manufactured: 11/11/2021
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male