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

Model Number	CNW0T4
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.(b)(4).
Event or Problem Description
A physician reported that following a cataract extraction with intraocular lens (iol) implant procedure, the pigment adhesion was confirmed during postoperative examination.The customer considered that the pigment derived from the iris and was considered not inflammatory, the involvement of the company lens material was suspected.Additional information has been requested.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.10.Three separate images were submitted within one photo for review.Image #1 (top left) is broad parallelepiped of moderate magnification focused at the level of the iol.Dense deposition of small round particulates are present throughout the illuminated surface of the iol.Coloration is difficult to ascertain, but the description as pigment as noted clinically is consistent with the image.Image #2 (top right) is a slightly broader parallelpiped than image #1, also of moderate magnification focused at the level of the iol.Dense deposition of small round particulates are present throughout the illuminated surface of the iol.Coloration is difficult to ascertain, but the description as pigment as noted clinically is consistent with the image.Image #3 (bottom left) is essentially equal to image #1.No root cause of the pigment can be ascertained from the images.Video review: one video was submitted for review.The video captured a single cataract surgery and was just over 10 minutes in length.Overall, the video is unremarkable.Orientation marks were placed at the limbus at the beginning of surgery at 12:00 and 6:00 as a toric iol was to be implanted.Once inserted the standard toric markings were visible on the iol.The iol appears clear with no deposits or additional markings or defects.Based on our observation of the attached photo/video, it appears that pigment adhesion is present.A definitive determination of the iol condition cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.The product history records confirm that the product met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC 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: 15493011
• Report Number: 9612169-2022-00492
• Device Sequence Number: 13917344
• Product Code: MJP
• UDI-Device Identifier: 00380652410199
• UDI-Public: 00380652410199
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2023

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 Model Number: CNW0T4
• Device Lot Number: ASKU
• 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: 09/06/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 01/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 IOL DELIVERY SYSTEM, CARTRIDGE D
• Patient Sex: Unknown