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

Model Number	CNWTT0
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product 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.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
A pharmacist reported that during an intraocular lens (iol) implant procedure, when the iol was came out of the cartridge, the end part of the iol optics was cracked.The defective iol was not implanted.There was no patient impact.
Additional Manufacturer Narrative
Additional information was added in h.6 and h.11.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 photos and video show an implanted intraocular lens (iol) on a monitor screen, there appears to be a large crack/mark near the optic edge.Returned photo shows an iol in three segments on top of a lens case.Based on our observation of the attached photo/video, there appears to be a large crack/mark near the optic edge.The origin of the observed crack/mark cannot be confirmed based on the returned video 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.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 TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 20739414
• Report Number: 9612169-2024-01205
• Device Sequence Number: 8297925
• Product Code: MFK
• UDI-Device Identifier: 00380652408226
• UDI-Public: (01)00380652408226(17)270107(11)230109(10)25567654
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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 Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.250
• Device Lot Number: 25567654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 02/04/2025
• Date Device Manufactured: 01/09/2023
• 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.; HIALURONATE DE SODIO30MG/ML, SN (B)(6).; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.
• Patient Age: 64 YR
• Patient Sex: Female