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

Model Number	CNWET3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Diplopia/Double Vision (4802)
Date of Event	09/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.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 can read normal size fonts on phone at a minimum distance of 19-20 - not the best.The patient good with medium distances like a tv; however, when driving at night, patient had challenges.At night, stop lights do not have halos, but seeing sort of a duplicate image offset by 45 degrees of so, as gets closer to 120 feet the traffic light perfectly clear.Car break lights in the distance look like perfect red dots with no halo or any other problem at all.During the daytime no problem with anything, except for reading my mobile device is further that patient expected.Additional information has been received and stated that, patient saw an optometrist who determine that had excellent vision but was unable to provide an opinion on why patient see duplicate objects at night.The patient underwent a yag procedure on the left eye, the ophthalmologist said the right lenses was clear.Afterwards, patient can see a slight vision improvement but still see a two images slightly offset to each other at a 45 degree angle.Same for stop light or any bright light at night.Yet, all freeways signs read perfectly clear.No problems during the day.
Additional Manufacturer Narrative
The product was not returned for analysis.The root cause for the reported complaint could not be determined.The product history records confirm that the product met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC 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: 18423096
• Report Number: 9612169-2024-00004
• Device Sequence Number: 7867406
• Product Code: MJP
• UDI-Device Identifier: 00380652485524
• UDI-Public: 00380652485524
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 02/07/2024

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: 01/08/2026
• Device Model Number: CNWET3
• Device Catalogue Number: CNWET3.110
• Device Lot Number: 25326574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 01/01/2024
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• 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
• Patient Age: 71 YR
• Patient Sex: Male