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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Physician reported after intraocular lens (iol) implant procedure cracks presented in the intraocular lens.Surgeon stated that the crack is not in the visual axis so did not explant.It was stated that skilled nurses implanted using different cartridges and he believes something is wrong with the intraocular lens (iol) material.There are two medical device reports associated with this complaint.This report is 1 of 2.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 h.3., h.6.And h.11.The product was not returned for analysis.The complainant indicates the use of company handpiece which is not qualified for use with the associated iol model.The reported complaint was not observed as no sample was returned for analysis; however, based on the information provided by the customer, the most likely root cause is failure to follow instructions for use (ifu), as the surgeon states the use of non qualified injector.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.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: 21678482
• Report Number: 9612169-2025-00458
• Device Sequence Number: 15531581
• Product Code: POE
• UDI-Device Identifier: 00380652405331
• UDI-Public: (01)00380652405331(17)251214(11)211216(10)25325665
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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: 12/14/2025
• Device Model Number: CNWET0
• Device Catalogue Number: CNWET0.245
• Device Lot Number: 25325665
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 06/12/2025
• Date Device Manufactured: 12/16/2021
• 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 CARTRIDGE D; MONARCH III INJECTOR
• Patient Sex: Unknown