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	Headache (1880); Blurred Vision (2137); Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 had decreased near vision, could not read small print and dim light, could not read from computer, ipad, cell phone and books.Lights constantly gave a small rainbow at edge of right eye if reflected a certain way.The patient also had some strobe like issues when going from inside to outside and any change in lighting.The patient was told her retina was fine and need reading glasses so that she could read and to complete her routine activities.Additional information has been requested.There are two medical device reports associated with this patient.This report is associated with the right eye.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested, received and stated the patient is very tired of headaches from string to see.
Event or Problem Description
Additional information has been received and stated the patient symptoms were still continuing and she had consultation where she was advised to have the lens removed.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in d.6.B., b.5., h.3.And h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated the lens explantation has been scheduled.Additional information has been received and stated the lens was exchanged with another company lens.There are two medical device reports associated with this patient.This report is associated with the right eye.

• 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: 17478291
• Report Number: 9612169-2023-00576
• Device Sequence Number: 2493706
• Product Code: MJP
• UDI-Device Identifier: 00380652486026
• UDI-Public: 00380652486026
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/23/2024

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: 07/05/2026
• Device Model Number: CCWET3
• Device Catalogue Number: CCWET3.110
• Device Lot Number: 25443386
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 09/05/2023; 11/28/2023; 01/25/2024
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/26/2023; 12/26/2023; 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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: Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Female