MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWTT3
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that the surgeon found metal particle embedded in the periphery of the iol when implanted.Lens was explanted before the patient left the operation room and sent for electron microscopy.Additional information has been requested.
Additional Manufacturer Narrative
A sample device 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.Photos reviewed show what appear to be black spots on the iol implanted in the eye.Another picture shows an iol on a plastic bag, there appears to be foreign material on the iol.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The iol was returned for analysis and the reported complaint was not observed.A photo was provided showing the reported "foreign object on lens".Iol returned in a gauze bag.The iol is immersed in solution.One haptic tip is nicked, the other haptic is intact.The optic is cracked/fractured and scratched/marked-rejectable.No embedded particulate observed.Iol cleaned.No embedded particulate observed.Based on our observation of the attached photo, black spots can be seen on the iol implanted in the eye.The reported "foreign object on lens" was not observed on the returned iol.A final root cause cannot be determined based on available information and without the evaluation of the physical sample of "foreign object ".The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING 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: 17815762
• Report Number: 9612169-2023-00669
• Device Sequence Number: 17693603
• Product Code: MJP
• UDI-Device Identifier: 00380652457286
• UDI-Public: 00380652457286
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2023

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 Expiration Date: 04/16/2026
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.150
• Device Lot Number: 25398535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III INJECTOR
• Patient Sex: Unknown