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

Model Number	CNWET3
Medical Device Problem Codes	Break (1069); Inaccurate Delivery (2339)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported with a description of lens faulty (not haptic) / lens could not be used.Additional information was received stating scrub nurse loaded the lens into cartridge and injector as usual.When surgeon inserting lens into the eye realised that the lens was loaded upside down so he aborted and upon pulling out lens trailing haptic broke off.Surgeon was then able to successfully remove the rest of the lens out of the main wound.The procedure was completed with back up lens with no issues.
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
Additional information was provided in d.9., h.3., h.6.And h.11.Correction information was provided in h.6.Fda product codes (a140504) has been added.The reported complaint was not observed as insufficient sample was returned for analysis.No lens received, lens case returned empty.Opened iol carton, secondary labels sheet and patient implant reply card returned.We are unable to determine the root cause for the reported complaint "lens trailing haptic broke off, in and out, lens was loaded upside down" as no iol was returned for evaluation.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: 22861045
• Report Number: 9612169-2025-01686
• Device Sequence Number: 7622809
• Product Code: MJP
• UDI-Device Identifier: 00380652466448
• UDI-Public: (01)00380652466448(17)280715(11)240717(10)25890053
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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: CNWET3
• Device Lot Number: 25890053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/27/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• 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 IV INJECTOR; MONARCH III IOL CARTRIDGE D
• Patient Sex: Unknown