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

Model Number	CNAET6
Medical Device Problem Codes	Failure to Deliver (2338); Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, the lens was compressed by plunger when the injector was fully push, the lens was able to be delivered, however the lens was damaged with scratches.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photo was returned.Plunger underride was observed on the returned photo.Photos provided show two company devices.The plunger appears to be fully advanced in both and appears to underride the intraocular lens (iol) in both.An additional photo shows what appears to be an implanted iol on a monitor screen.The reported scratch is not observed.We are unable to determine the root cause for the reported complaint injector trapped iol, with scratch.The product was not returned for analysis.Plunger underride was observed on the returned photo.The reported scratch was not observed.Plunger underride may occur: ¿ if the lens has become misaligned in the lens bay during the manufacturing process.¿ due to the use of a non-qualified viscoelastic.Material properties of non-qualified ophthalmic viscosurgical device (ovds) may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.¿ if inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device allowing the plunger to underride the lens.¿ if the operating room temperature is too high (greater than (>) 23 degrees centigrade (°c) / 73 degrees fahrenheit (°f)) lens folding consistency is negatively affected, the lens is more adherent, and this may inhibit lens advancement.¿ if ovd has not been allowed to come to operating room temperature over a 20-minute timeframe prior to use.Colder temperatures can increase the ovd viscosity, creating greater resistance during iol delivery, causing potential unsuccessful delivery outcomes.Any of the above listed causes alone, or in combination, may create the reported event.Based on the results from the manufacturing batch record, the products met release criteria.Investigation has been completed based on current information.No further action is warranted at this time.Based on our trend analysis, there are no adverse trends identified for this complaint and based on these findings the residual risk remains at an acceptable level.Investigation has been completed based on current information.No further action is warranted at this time.Based on our trend analysis, there are no adverse trends identified for this complaint and based on these findings the residual risk remains at an acceptable level.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL W/AUTONOME DELIVERY SYSTEM
• 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 fwy; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 25677863
• Report Number: 9612169-2026-01472
• Device Sequence Number: 18555892
• Product Code: MJP
• UDI-Device Identifier: 00380652460880
• UDI-Public: (01)00380652460880(17)290913(11)250915(10)26115997
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: CNAET6
• Device Catalogue Number: CNAET6.235
• Device Lot Number: 26115997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 07/01/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 09/15/2025
• 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: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Sex: Unknown