MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CNWET0
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient reason and clinical reason for explant was lens not centered.The iol was exchanged for advanced technology intraocular lenses (atiol) model 21 days following the initial implant procedure.Additional information has been received stating explanted and replaced with non company iol.

• Brand Name: CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20405366
• Report Number: 9612169-2024-01004
• Device Sequence Number: 6545897
• Product Code: POE
• UDI-Device Identifier: 00380652405171
• UDI-Public: (01)00380652405171(17)250403(11)211110(10)25298590
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2025
• Device Model Number: CNWET0
• Device Catalogue Number: CNWET0.165
• Device Lot Number: 25298590
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 10/09/2024
• Date Device Manufactured: 11/10/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH II LOADING FORCEPS; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown