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

Model Number	CNWET5
Medical Device Problem Codes	Optical Decentration (1360); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that the first lens had to be explanted because it was damaged by the injector.Additional information has been requested and received stating that the, during initial surgery, iol did not center initially in the or but with rotation looked centered.No damage to the iol was noted at that time.There was a slight decentration post operative day one and was worsen, so a repositioning or exchange was broken.Intraoperatively it was noted that there was a tear in the iol at one optic/haptic junction so the iol was removed in one piece and exchanged with a new iol without complications.It was reported that the iol was in good position.
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).
Additional Manufacturer Narrative
Additional information has been provided in d.9., h.3., h.6., and h.11.The product was returned for analysis and the reported complaint was not observed.The iol was damaged and this damage was not mentioned by the customer.Iol returned pressed down on two posts of the lens case base.Solution is dried on the iol.Both haptics are deformed.The tip of one haptic is broken/torn and is not returned.The optic is deformed, the optic surface is scratched/marked-rejectable.No root cause identified as the reported complaint "tear in the lens at one optic/haptic junction" was not observed.Other damage to the iol was observed.The product was subject to handling and the reported damage was highlighted post implantation.The reported complaint is lacking in relevant information such as associated products (cartridge, handpiece, viscoelastic) used to complete a thorough investigation.Due to the lack of information, we are unable to verify if the product contributed to the event.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: 24051656
• Report Number: 9612169-2026-00123
• Device Sequence Number: 15958362
• Product Code: MJP
• UDI-Device Identifier: 00380652467230
• UDI-Public: (01)00380652467230(17)270821(11)230823(10)25700960
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNWET5
• Device Lot Number: 25700960
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/08/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female