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

Model Number	CCWET3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Intraocular Pressure Decreased (4468); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/14/2023
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 consumer reported that following intraocular lens (iol) implantation, the distance vision was bad but near vision was better.Consumer had some swelling and also the intraocular pressure (iop) was low (10), which caused bad vision at distance.Consumer was told to continue drops and to wait for the swelling to go down.The consumer was home bound and could not drive.Additional information was received.The vision was 5-10% better, but later it was back to the way it was previously.The patient had improved a lot.The blurry vision was caused due to swelling in the back of the eye.The doctor has been tapering off the steroid drops and would continue to see how the symptoms improve.As of now, the patient has a bit of myopic outcome, measuring -1.50.The vison was much better the last couple of days, though recently there was worse fluctuation in vision.The patient would consult the doctor to see if there is a need to alter the drops again.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
The patient's symptoms showed slow gradual improvement, but then stopped as the patient developed posterior capsular pacification (pco).Yttrium-aluminum-garnet (yag) laser surgery has been planned to open up the capsular bag which could help the cloudiness.The doctor could see this has developed along with a 60 degree fold line in bag causing glare lines in patient's vision.Prior to pco the patient noticed that it was difficult to see clear while driving on cloudy days or indoors in dim lighting.

• 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: 18301084
• Report Number: 9612169-2023-00885
• Device Sequence Number: 3225282
• Product Code: MJP
• UDI-Device Identifier: 00380652455411
• UDI-Public: 00380652455411
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2024

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: 04/23/2026
• Device Model Number: CCWET3
• Device Catalogue Number: CCWET3.265
• Device Lot Number: 25399213
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female