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	Device Difficult to Setup or Prepare (1487); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported before intraocular lens (iol) implant procedure, there was some difficulty loading in the lens.The haptic arms were unfolding and there was some resistance.Lens did not look damaged but surgeon did not feel comfortable loading it again and used the back-up lens.The procedure was completed on same day.Additional information has been requested.
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 was provided in h.3., h.6., and h.11.The product was returned for analysis and damage was observed to the intraocular lens (iol).No cartridge was returned.The iol was returned positioned correctly in the lens case.Solution was dried on the optic and both haptics.One haptic was bent/deformed, while the other remained intact.The optic was scratched/marked rejectable.The iol met specifications when dimensionally measured for edge thickness and plan view.The provided photo (image-1) shows an iol in a lens case base.The lens is not positioned correctly in the lens case well.One haptic appears bent/deformed.The optic appears damaged and a white line/mark is visible on it.The product investigation could not identify the root cause for the reported complaint, "difficulty loading lens.Haptic arms were unfolded with some resistance," as only the iol was returned for evaluation.No cartridge was returned.Due to this, a thorough investigation could not be completed.The lens dimensions were tested using an approved template and found to be within specification.Based on the results from the product history record review, the product 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: 21857507
• Report Number: 9612169-2025-00615
• Device Sequence Number: 11941901
• Product Code: MJP
• UDI-Device Identifier: 00380652467186
• UDI-Public: (01)00380652467186(17)280123(11)240125(10)25784124
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: CNWET5
• Device Catalogue Number: CNWET5.215
• Device Lot Number: 25784124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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 DELIVERY SYSTEM, INJECTOR; MONARCH IOL DELIVERY SYSTEM, CARTRIDGE; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown