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

Model Number	CNWTT6
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported during an cataract surgery (iol) implant procedure, scratch or adherence found on the periphery of the lens optic immediately after lens insertion.The surgery was performed and completed.Currently, the patient's visual acuity was 1.2, and although the patient had no complaints, he/she was under observation.The sample was not available as it still remain in the patient's eye.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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).
Additional Manufacturer Narrative
Additional information was added in b.5.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received and stated that the patient visual acuity was good and the patient satisfaction was high.The physician stated that it was difficult to check the condition of the intraocular lens as it required to dilate the pupils.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photo was returned.The reported complaint was observed on the returned photo.Provided photos show an implanted intraocular lens (iol).There appear to be a mark/line at the edge of the iol optic.Based on our observation of the attached photo, 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 alone and without evaluating the physical product.The product was subject to handling and the reported damage was highlighted post implantation.A final root cause cannot be determined based on available information.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed mark/line would not meet our current release criteria.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 PANOPTIX TORIC TRIFOCAL 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: 21167701
• Report Number: 9612169-2025-00108
• Device Sequence Number: 21189577
• Product Code: MJP
• UDI-Device Identifier: 00380652469845
• UDI-Public: (01)00380652469845(17)260712(11)220714(10)25442777
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2025

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: 07/12/2026
• Device Model Number: CNWTT6
• Device Catalogue Number: CNWTT6.060
• Device Lot Number: 25442777
• 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: 12/24/2024
• Supplement Date Received by Manufacturer: 01/22/2025; 02/21/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/18/2025; 03/20/2025
• Date Device Manufactured: 07/14/2022
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; CLAREON MONARCH IV IOL, INJECTOR; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL, CARTRIDGE D; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown