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

Model Number	CNWTT0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during an intraocular lens (iol) implant procedure, the haptics was torn from the iol.The iol was removed and with same model lens.Additional information has been received that the patient's condition is satisfactory.There was no medical intervention and product has not been reused.Additional information has been received that there was no threat of the patient life and health.
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
The product was not returned for analysis.Only photo was returned.The reported complaint was observed on the returned photo.Provided photos show an iol lens case, iol carton and iol in a lens case base.The iol in the lens case base is not positioned correctly in the well; it is off the centre.The optic appears to be broken and deformed/folded.One haptic appears to be damaged/deformed.The other haptic is not visible and appears to be missing.Based on our observation of the attached photo, the optic appears to be broken and deformed/folded.One haptic appears to be damaged/deformed.The other haptic is not visible and appears to be missing.The origin of the observed damage 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.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: 22494622
• Report Number: 9612169-2025-01379
• Device Sequence Number: 11805887
• Product Code: MFK
• UDI-Device Identifier: 00380652408264
• UDI-Public: (01)00380652408264(17)260917(11)220919(10)25487245
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

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: 09/17/2026
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.270
• Device Lot Number: 25487245
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 10/06/2025
• Date Device Manufactured: 09/19/2022
• 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 PANOPTIX TRIFOCAL LENS.; MONARCH II CARTRIDGE B.; PROVISC.; VISCOAT.
• Patient Sex: Male