MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CNWET0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2025
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.Provided photos show the lens positioned incorrectly in the lens case.One haptic is broken in the gusset area and appears to either be adhered to the posterior side of the optic or in the well area of the lens case.Solution appears to be on the lens.However, due to the angle and blurriness of the photo we cannot confirm handling without a physical sample evaluation.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that when preparing the lens for a surgery they noticed that one of the haptics was broken.They suspended the surgery on that eye and opted to operate on the patient's other eye.The surgery was rescheduled for (b)(6) 2025.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned.Two photos were provided of the lens.The provided photos showed the lens in the lens case base from two different angles.The yellow, single-piece lens was positioned incorrectly in the lens case.One haptic was broken in the gusset area and appeared to be adhered to the posterior side of the optic or in the well area under the optic.Viscoelastic appeared to be present; however, due to the angle and clarity of the photo, it could not be confirmed.Complaint history and product history records were reviewed, and documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified associated products were used.Based on review of the provide photo, one haptic was broken.Due to the clarity of the photos, handling could not be verified.The root cause for the broken haptic could not be determined.It is unknown if the event occurred during lens loading.It is unknown if qualified associated products were used.The instructions for use (ifu) instructs company foldable intraocular lenses (iols) are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Due diligence has been performed in an attempt to obtain further information on this event.The facility has not responded to requests for follow-up information.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21678005
• Report Number: 1119421-2025-00806
• Device Sequence Number: 15395595
• Product Code: POE
• UDI-Device Identifier: 00380652405331
• UDI-Public: (01)00380652405331(17)280224(11)240226(10)15811297
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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): 05/16/2025

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: CNWET0
• Device Catalogue Number: CNWET0.245
• Device Lot Number: 15811297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2024
• 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
• Patient Sex: Unknown