MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNWET5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
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 during intraocular lens (iol) implant procedure, the surgeon noticed one of the haptics was not attached properly.Surgeon decided to explant the iol during which the haptic came off as the iol was being rotated out of the bag immediately explanted and backup utilized during initial procedure.The procedure was completed on same day without any harm to the patient.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 damage was observed to the intraocular lens (iol).Iol returned positioned incorrectly in the iol case.Substantial amount of solution is dried on the iol.The optic is broken into two segments.One haptic is broken and attached to the optic with the tip with solution.The other haptic is deformed.We are unable to determine the root cause for the reported complaint "haptic came off".The iol was returned in two segments, which is consistent with lens having been explanted.The product was subject to handling and the reported damage was highlighted post implantation.We are unable to verify if the product contributed to the event.In addition to this, all iols are 100 percentage cosmetically inspected as per approved manufacturing procedures and the observed lens damage/condition would not meet our current release criteria.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 VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 23410636
• Report Number: 9612169-2025-02163
• Device Sequence Number: 18749748
• Product Code: MJP
• UDI-Device Identifier: 00380652467186
• UDI-Public: (01)00380652467186(17)280505(11)240507(10)25845414
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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: CNWET5
• Device Lot Number: 25845414
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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.; DUOVISC VISCOELASTIC SYSTEM.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.
• Patient Sex: Unknown