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

Model Number	CNWET6
Medical Device Problem Codes	Break (1069); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, while loading the lens, haptic broke.The doctor also complained that this lens was softer than usual company lens.The procedure was completed on the same day.There was no patient harm and no patient contact.
Additional Manufacturer Narrative
Additional information has been provided in d.9., h.3., h.6., h.11.The iol in cartridge was returned for analysis.Observation indicate plunger override occurred.The lens was returned in a company cartridge, cavity 1.Viscoelastic was observed in the cartridge.The broken leading haptic was returned at the loading area.The lens was advanced to the nozzle entry area.The trailing haptic was extended back.The broken leading haptic and trailing haptic position indicate a plunger override occurred.The company cartridge was cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.We are unable to determine the root cause for the reported complaint lens haptic broken during lens loading.The cartridge with iol were returned for analysis.The lens was misfolded in the cartridge.The trailing haptic was extended back.The broken leading haptic and trailing haptic position indicate a plunger override occurred.The ifu instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd-filled cartridge.The lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.Important: the plunger should make initial contact with the cartridge at the ramp.In the event the plunger does not contact the cartridge at the ramp, do not use the handpiece and contact company.The handpiece ifu instructs: verify that the plunger tip is properly engaging the lens optic and that the lens moves forward at the same rate as the plunger while slowly advancing the plunger forward to avoid damaging the lens.When the threads on the knob make contact with the barrel, turn the knob clockwise approximately ½ turn to engage the threads and then stop.The iol will now be in the dwell position.Inspect to ensure the plunger is behind the optic.The doctor also reported this lens is softer than usual company lens.The ifu recommends: use the company cartridge at operating room temperatures between 18° celsius (64° fahrenheit) and 23° celsius (73° fahrenheit).If the operating room temperature is too high (> 23° celsius / 73° fahrenheit) lens folding consistency is negatively affected, the lens is more adherent, and this may inhibit lens advancement.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: 23619443
• Report Number: 9612169-2025-02327
• Device Sequence Number: 9072243
• Product Code: MJP
• UDI-Device Identifier: 00380652467612
• UDI-Public: (01)00380652467612(17)280210(11)240212(10)25804491
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 02/09/2026

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: CNWET6
• Device Lot Number: 25804491
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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 MONARCH IV IOL, INJECTOR.; DISCOVISC OVD.; MONARCH III IOL, CARTRIDGE D.
• Patient Sex: Unknown