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 Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported with a description of intraocular lens was faulty which had a damaged haptic.Additional information has been received and stated that the trailing haptic was involved.The leading haptic of the intraocular lens was in patients eye however the trailing haptic was not.Lens was removed at the time of insertion and had not completely passed into the eye when noticed the defect in the haptic.The procedure was completed with the back up iol and there was no patient harm.
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).
Additional Manufacturer Narrative
Additional information was provided in d.4.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: 21534021
• Report Number: 9612169-2025-00330
• Device Sequence Number: 20582948
• Product Code: MFK
• UDI-Device Identifier: 00380652408196
• UDI-Public: (01)00380652408196(17)260604(11)220606(10)25424055
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 06/04/2026
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.235
• Device Lot Number: 25424055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 05/14/2025
• Date Device Manufactured: 06/06/2022
• 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: DUOVISC VISCOELASTIC SYSTEM; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED
• Patient Sex: Unknown