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

Model Number	CCWET4
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
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 patient reported that after the implantation of intraocular lens in the right eye, the patient's vision was blurry and the lens got rotated the surgeon then advised to do lasik surgery and hence two lasik surgeries was done for the right eye and now the patient's vision is clear and the patient can clearly see far away.However, the patient stated that, on looking into a person the patient could see the glowing blue, like blue tint in the vision.Therefore the surgeon advised that the patient might require an explant and the lens can be replaced with a monofocal lens.Additional information was received stating that, the patient could not see far and intermediate distances.The patient was able to see clear far away, but do get lots of chromatic aberrations, also near vision is not sharp, 20 inches from the face, the patient was experiencing shadows under letters, ghosting.One week after the implantation, the patient consulted the physician via phone and he suggested to use drops for now which will make pupil larger or smaller to check if the patient gets the same symptoms so that the physician will follow up with the patient later.The patient was willing to remove this lens and get monofocal instead.The patient was relying only on my unoperated eye (left eye).Also doctor suggested to implant monofocal iol in the left eye.Since the patient was having terrible issues with the 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: 17162708
• Report Number: 9612169-2023-00467
• Device Sequence Number: 12117873
• Product Code: MJP
• UDI-Device Identifier: 00380652455763
• UDI-Public: 00380652455763
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 06/20/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2026
• Device Model Number: CCWET4
• Device Catalogue Number: CCWET4.260
• Device Lot Number: 25362368
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2022
• 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: 45 YR
• Patient Sex: Male