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

Model Number	CNWTT0
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
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 non health care professional reported that during surgery while folding the lens into the monarch, the instrument operator noticed that the lens was damaged.Procedure completed by using the new unspecified lens.No complications was reported.Additional information has received and it states that during the operation, the surgeon unpacked the lens and gave it to the operator.She started folding it with company folding tweezers and when the lens was half in the monarch, she noticed that the lens was damaged at the edge of the optic.After consulting with the surgeon, a new lens was used and this lens was kept for complaint.There was no contact with the patient.
Additional Manufacturer Narrative
Additional information has been provided in d.9., h.3., h.6., and h.11 the product was returned for analysis and the reported complaint was observed.Iol (intraocular lens) returned positioned incorrectly in the iol case.Solution is dried on the iol.The haptics are scratched/marked-rejectable.The optic edge is nicked/chipped-rejectable, the optic surface is scratched/marked-rejectable.We are unable to determine the root cause for the reported complaint lens was damaged at the edge of the optic.The product was subject to handling and the reported damage was highlighted when the iol was halfway in the cartridge.In addition to this, all iols are 100 percent cosmetically inspected as per approved manufacturing procedures and the observed lens damage/condition would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.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: 21594441
• Report Number: 9612169-2025-00372
• Device Sequence Number: 8330869
• Product Code: MFK
• UDI-Device Identifier: 00380652408097
• UDI-Public: (01)00380652408097(17)260711(11)220713(10)25443016
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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: 07/11/2026
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.185
• Device Lot Number: 25443016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2022
• 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 II LOADING FORCEPS; MONARCH III IOL CARTRIDGE D; PROVISC OVD
• Patient Sex: Unknown