MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON 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	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure on (b)(6) in the left eye, disappointed in that the intermediate vision focal length, while improved, was not 20/20, patient was referring to a range of 5 to 20 feet in distance.In particular, watching a 65' high def tv with uhd still requires glasses to achieve complete acuity and sharpness.Estimated vision at that distance to be about 20/25.Consumer agrees that the long range (i.E., driving) was 20/20 and could usually make out instrument panel in the car, but somewhat blurred.Additional information was requested and received stating that the patient wanted to know why his left eye vision was now less than the right when it was the stronger of the two mid range.And why "functional vision" was worse for close range than before the implants.While he eat or read, my food or phone was blurry than prior to implants.The prescription was the current glasses that he wear to watch tv and read the computer.Patient experienced night time driving harder than before.Had halos and tail lights were like starbursts.He started experiencing symptoms one month after surgery.Left eye was the stronger (sharper) of the two, now is weaker vision.Optometrist provided new prescription for progressive glasses, which are now being used.As per the consumer, this issue was now getting resolved by another facility.He will be receiving lasik surgery for the left eye to correct the vision issue which currently was 20/40.There are two medical reports associated with this patient.This file belongs to the left eye.
Additional Manufacturer Narrative
A product 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).
Additional Manufacturer Narrative
Corrected information provided in d.4.Additional information provided in h.6., and h.11.The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.Associated products were not provided.The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.Each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The report was the patient.Follow up information was provided by the patient that they were going to have lasik surgery to correct the vision issue.The requested closure of the case.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 20037988
• Report Number: 1119421-2024-01612
• Device Sequence Number: 12389076
• Product Code: MJP
• UDI-Device Identifier: 00380652455190
• UDI-Public: (01)00380652455190(17)260216(11)220218(10)15354728(21)15354728018
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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: 02/16/2026
• Device Model Number: CCWET3
• Device Catalogue Number: CCWET3.155
• Device Lot Number: 15354728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 11/15/2024
• Date Device Manufactured: 02/18/2022
• 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: 69 YR
• Patient Sex: Male