MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CNWET0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
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 health care professional reported that during an intraocular lens (iol) implant procedure, the lens was mounted as indicated by the manufacturer's instructions.The lens was advanced without any problems.The surgeon injected the lens.At the time of injection, the front haptic entered normally, while the rear haptic fractured.The lens was removed by cutting it and replaced with another new lens of the same power and reference.The procedure was completed on the same day without complications.As per the surgeon, the probable cause of the event was that the lens probably got stuck in the injector.Additional information was requested and received, confirming that no treatment was prescribed.The patient's issues resolved without harm or impact.
Additional Manufacturer Narrative
Additional information was provided in d.9., d.10., h.3., h.6.And h.11.The product was returned for analysis and damage was observed to the intraocular lens (iol).Iol returned loose on a piece of medical gauze in a sealed non-company pouched.Company cartridge also received in the pouch.Solution is dried on the iol.One haptic is broken/torn and not returned, the other haptic is marked.The optic is cracked and returned in two segments: 1/4 and 3/4 in size.Unable to conduct dimensional testing due to condition of returned sample.The used company cartridge was evaluated.Viscoelastic was observed in the cartridge.The cartridge had evidence of placement into a handpiece.No damage was observed.The used company cartridge was cleaned for further evaluation.Topcoat dye stain testing was conducted with acceptable results.A product history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.We are unable to determine the root cause for the reported complaint "rear haptic fractured, lens was removed by cutting it and replaced".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.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 the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• 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: 22766697
• Report Number: 9612169-2025-01612
• Device Sequence Number: 15491968
• Product Code: POE
• UDI-Device Identifier: 00380652405256
• UDI-Public: (01)00380652405256(17)280609(11)240611(10)25867126
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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: CNWET0
• Device Catalogue Number: CNWET0.205
• Device Lot Number: 25867126
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 08/09/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; UNSPECIFIED OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Age: 68 YR
• Patient Sex: Female