MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON 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 Codes	Loss of Vision (2139); Visual Disturbances (2140)
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 she has experience a blind spot in bottom portion of lens.Both eyes seem to be working against each and fluorescent lights are extremely bright since surgery.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed, and the 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 consumer reported that it feels like they have a "blind spot in bottom portion of the lens.Both eyes seem to be working against each other.Fluorescent lights are extremely bright since surgery".The product was not returned.Each lens is subjected to a 100 percentage assessment of the power (sphere and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The consumer was advised to speak to the implanting surgeon regarding issues they are experiencing or seek a second opinion.Company is unable to provide medical advice or recommendations.The consumer reported consulting a second opinion and this specialist told him the lens was a regular toric.The presence of the company lens optic characteristic is possible due to a validated process which is measured and precise in order to deliver the expected optical performance per lens model and diopter.The visual confirmation of that vivity characteristic on the optic can be problematic to an untrained eye, or without the correct lighting and angle of viewing of the advanced technology lens model.A slit lamp photo was not provided for review.File will be reopened if new information or the sample is received.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 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: 19679864
• Report Number: 1119421-2024-01266
• Device Sequence Number: 3212550
• Product Code: MJP
• UDI-Device Identifier: 00380652466424
• UDI-Public: (01)00380652466424(17)261107(11)221109(10)15530254(21)15530254039
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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 Model Number: CNWET3
• Device Catalogue Number: CNWET3.195
• Device Lot Number: 15530254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 09/19/2024
• Date Device Manufactured: 11/09/2022
• 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 Sex: Male