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 Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during an intraocular lens (iol) implant procedure, cracked lens during loading.There was a patient contact and no patient harm.Lens was explanted in initial procedure.
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 iol.Iol received in two segments, one adhered to a piece of carton, the other loose in a zip lock bag.Solution is dried on the iol (intraocular lens).The reported crack cannot be confirmed due to condition of the returned sample.The sample was cleaned for further evaluation.One haptic is nicked/chipped-rejectable, which could have been interpreted as the reported complaint.The optic is scratched/marked-rejectable.The complainant indicates the use of a company iol delivery device which is not recommended for use with this model.We are unable to determine the root cause for the reported complaint "cracked lens (in and out)".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% 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: 22305610
• Report Number: 9612169-2025-01270
• Device Sequence Number: 18141993
• Product Code: MJP
• UDI-Device Identifier: 00380652466493
• UDI-Public: (01)00380652466493(17)261120(11)221122(10)25538199
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: 25538199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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 VIVITY TORIC HYDROPHOBIC IOL; MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC OVD
• Patient Sex: Unknown