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 Code	Visual Impairment (2138)
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 facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced refractive surprise.The iol was exchanged for another lens model following the initial implant procedure.
Additional Manufacturer Narrative
The product was not returned.Complaint history and product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Not enough information was provided for further investigation.The reporting facility has not provided any further information.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
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 (1.50cyl), 18.0 diopter lens (extended 1.5 diopters of focus) was exchanged for a non-company 16.0 diopter lens.The 2.0 diopter change may indicate there was a calculation issue.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: 18710987
• Report Number: 1119421-2024-00285
• Device Sequence Number: 17820397
• Product Code: MJP
• UDI-Device Identifier: 00380652455244
• UDI-Public: 00380652455244
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2024
• 2 Devices were Involved in the Event: 1 2

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: 06/26/2026
• Device Model Number: CCWET3
• Device Catalogue Number: CCWET3.180
• Device Lot Number: 15440747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 03/15/2024; 05/20/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 04/12/2024; 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• 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: 66 YR
• Patient Sex: Male