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 Disturbances (2140)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.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 non-healthcare professional reported about an intraocular lens (iol) explant due to patient experienced obscured vision.The clinical reason was reported to be obscured vision.The iol was replaced with unspecified lens approximately one month after initial procedure.Additional information was requested, but no further information is available.
Event or Problem Description
Additional information was requested and received.Explant was due, to anisometropia and aniseikonia.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation, indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The product was not returned.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.Information was provided, that the explant occurred.The replacement lens model/diopter were not provided.It was indicated, as non-company.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: 18804822
• Report Number: 1119421-2024-00355
• Device Sequence Number: 7248701
• Product Code: MJP
• UDI-Device Identifier: 00380652455275
• UDI-Public: 00380652455275
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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: 01/23/2026
• Device Model Number: CCWET3
• Device Catalogue Number: CCWET3.195
• Device Lot Number: 15338679
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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: 80 YR
• Patient Sex: Female