MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON 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	Headache (1880); Visual Impairment (2138)
Date of Event	06/27/2022
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.There have been no other complaints reported in the lot number.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 could not read and distance vision was 20/60.Additional information has been requested and stated that, the patient had headache also.There are two medical device reports associated with this patient.This report is associated with the right eye.

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15518604
• Report Number: 1119421-2022-02096
• Device Sequence Number: 11435478
• Product Code: POE
• UDI-Device Identifier: 00380652405690
• UDI-Public: 00380652405690
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2022

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: 01/26/2026
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.160
• Device Lot Number: 15346395
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Unknown