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 Codes	Break (1069); Failure to Deliver (2338)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2026
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 the cataract surgery with intraocular lens (iol) implant procedure, difficulty was encountered in moving the iol in the delivery system, and haptic rupture was detected.Therefore, it was unsuitable for implantation.Another iol with the same characteristics was used to complete the surgical procedure.The reporter stated that, the defect might have originated during the manufacturing process.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The product was returned for analysis and damage was observed to the iol.No cartridge was returned.Intraocular lens (iol returned taped to the lens case base edge, outside of the well.Solution is dried on the lens.One haptic is broken/torn and is returned.The optic is cracked.The iol met specifications when dimensionally measured for edge thickness and plan view.The product investigation could not identify the root cause for the reported complaint "broken haptic" as only the iol was returned for evaluation.No cartridge was returned.Due to this, we are unable to complete a thorough investigation to determine a root cause.We are unable to verify if the iol contributed to the event.The dimensions of the lens were tested using an approved template and results show the lens dimensions to be within specification.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens condition would not meet our current release criteria.The product was subject to handling and the reported damage was highlighted during the implantation while the lens was in the cartridge.Based on the results from the product history record, the products met release criteria.Dings the residual risk remains at an acceptable level.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: 24415877
• Report Number: 9612169-2026-00422
• Device Sequence Number: 5917401
• Product Code: POE
• UDI-Device Identifier: 00380652405249
• UDI-Public: (01)00380652405249(17)280918(11)240920(10)25920541
• 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): 05/29/2026

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: CNWET0
• Device Catalogue Number: CNWET0.200
• Device Lot Number: 25920541
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• 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
• Patient Age: 64 YR
• Patient Sex: Female