MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CNWET0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that after having intraocular lens (iol) implantation surgery in the right eye, the vision was still fuzzy centrally.The near vision and peripheral vision was good, but consumer had trouble with central vision at distance.Consumer also had trouble with bright lights.Additional information was received.The vision was still not good.Consumer stated that the morning vision was not the best and consumer had somewhat blurry vision straight on, but if the consumer tilted the head, it was more clear through side vision.Consumer went to optometrist who insisted that the lens was in the correct spot.The optometrist suggested to use eye drops for one month.But there was no improvement.The optometrist also suggested some glasses, but could not find a lens that would correct it.The consumer also had awful glare in brightly lit areas, such as stores.
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).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed, and documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.The lens remained in the eye.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided by the patient in the initial report description that the patient "does not want us to contact the ecp or surgeon at this time".Follow up attempts were made for additional information.Response from the patient, provided in the file- was that the patient had since consulted with optometrist and the optometrist insisted that the lens was in the correct spot.The optometrist instructed the patient to continue with dropper medication.Three weeks passed at the point of the follow up and the patient reported there was no improvement so far.The optometrist also suggested glasses, but according to the patient, could not find a lens that would correct.If additional information becomes available, the file will be reopened and updated.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• 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: 18433397
• Report Number: 1119421-2024-00014
• Device Sequence Number: 6959464
• Product Code: POE
• UDI-Device Identifier: 00380652405294
• UDI-Public: 00380652405294
• 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): 02/16/2024

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: 02/22/2026
• Device Model Number: CNWET0
• Device Catalogue Number: CNWET0.225
• Device Lot Number: 15361319
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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 Sex: Female