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	Visual Impairment (2138); Eye Pain (4467); Unspecified Eye / Vision Problem (4471); Eye Irritation (4803)
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, the patient experienced eye pain, discomfort, and a pressure feeling from behind the eye.The patient had a macular pucker in the right eye prior to surgery.The eye was too big for the socket.The patient having issues with the ground looking uneven when she goes outside.The right eye makes objects look bigger.She cannot drive since surgery.The surgeon has seen her multiple times and restarted her on nonsteroidal anti-inflammatory drug to help with the discomfort but maybe it was making the eye feel worse.She was seen also by her retina doctor who said the macular pucker was stable.The patient feels that eyelid does not blink as it used to be.She had a long history of product and environmental allergies and wonders if her body is allergic or rejecting the lens implant.She will speak with her surgeon at next appointment.Additional information has been requested.

• 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: 22306766
• Report Number: 9612169-2025-01273
• Device Sequence Number: 15452988
• Product Code: POE
• UDI-Device Identifier: 00380652405621
• UDI-Public: (01)00380652405621(17)250406(11)211113(10)25307381
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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: 04/06/2025
• Device Model Number: CCWET0
• Device Lot Number: 25307381
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 06/23/2025
• Date Device Manufactured: 11/13/2021
• 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: BLINK AT; DICLOFENAC OPHTH SOL
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female