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	Insufficient Information (4580)
Date of Event	01/13/2025
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 nurse reported crack in the center while loading the intra ocular lens.The procedure was completed on the same day using an exchange intraocular lens.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6 and h.11.The product was returned for analysis and the reported complaint was observed.Intraocular lens (iol) returned wrapped in gauze in three segments.Solution is dried on the iol.There are fibers adhered to both haptics.The optic is torn or split cut dividing the iol in three, with two pieces stuck together.There are fibers adhered to the optic.There are two scratches in the centre piece of the optic.The complainant indicates the use of hyaluronic acid as a viscoelastic which is not qualified for use with the associated iol model.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow instructions for use (ifu), as the surgeon states the use of non-qualified combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.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: 21344220
• Report Number: 9612169-2025-00181
• Device Sequence Number: 8950477
• Product Code: MFK
• UDI-Device Identifier: 00380652408004
• UDI-Public: (01)00380652408004(17)261207(11)221209(10)25548942
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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: CNWTT0.140
• Device Lot Number: 25548942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2022
• 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, INJECTOR.; MONARCH III IOL, CARTRIDGE D.; OVD: HYALURONIC ACID.
• Patient Sex: Unknown