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

Model Number	CNWET4
Medical Device Problem Codes	Material Discolored (1170); Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, surgeon noticed marks on the anterior optic of the iol.He said that although it was a coating on the iol the coating came off while he was rotating the iol with the bi-manual irrigation and aspiration handpieces.He confirm that these markings were only visible on the iol and not caused by forceps during iol lens loading.
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).
Additional Manufacturer Narrative
The product was not returned for analysis.Only photo was returned.Photo provided showing an implanted iol (intra ocular lens).Marks/lines are visible on the optic.The exact location of the observed lines/marks cannot be confirmed.The reported coating on iol could not be confirmed on the returned photo.Based on our observation of the attached photo, there are lines/marks on the iol.A definitive determination of iol condition cannot be made without the evaluation of the physical product.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: 19457456
• Report Number: 9612169-2024-00516
• Device Sequence Number: 20498411
• Product Code: MJP
• UDI-Device Identifier: 00380652466752
• UDI-Public: (01)00380652466752(17)270407(11)230409(10)25619906(21)25619906089
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/21/2024

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: CNWET4
• Device Catalogue Number: CNWET4.180
• Device Lot Number: 25619906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 08/22/2024
• Date Device Manufactured: 04/09/2023
• 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 IOL DELIVERY SYSTEM, INJECTOR; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown