MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNWET3
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Returned photo shows an implanted iol.There appears to be a mark/line/scratch on the optic.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 physician reported with a description of a peripheral arc shaped scratch/defect was notice on a intraocular lens (iol) after implantation.The lens remains in the patients eye and the cataract procedure continued without incident.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned for analysis.Only photo and video were returned.The reported complaint was observed on the returned photo and video.Returned photo shows an implanted intraocular lens (iol).There appears to be a mark/line/scratch on the optic.The returned video shows an implanted intraocular lens (iol).The steps related to cartridge/iol preparation and the implantation procedure are not demonstrated.There appears to be a mark/line close to the edge of the iol optic.The origin of this mark/line cannot be confirmed based on the returned video alone and without evaluating the physical product.Based on our observation of the attached photo and video, there appears to be a mark/line close to the edge of the iol optic.The origin of the observed mark/line cannot be confirmed based on the returned photo and video alone and without evaluating the physical product.The product was subject to handling and the reported complaint was highlighted post implantation.A final root cause cannot be determined based on available information.Based on the results from the product history record, the products met release criteria.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 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: 20349922
• Report Number: 9612169-2024-00985
• Device Sequence Number: 20794104
• Product Code: MJP
• UDI-Device Identifier: 00380652485500
• UDI-Public: (01)00380652485500(17)270328(11)230330(10)25619944(21)25619944007
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNWET3
• Device Catalogue Number: CNWET3.100
• Device Lot Number: 25619944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/29/2024
• Date Device Manufactured: 03/30/2023
• 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: CLAREON MONARCH IV INJECTOR; CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; DUOVISC; DUOVISC VISCOELASTIC SYSTEM
• Patient Sex: Unknown