MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWET4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A non-health care professional reported that following an intraocular lens (iol) implant procedure,lens was explanted in a secondary procedure due to patient experienced very poor night vision (26pt) day vision not clear.The clinical reason was reported to be dysphotopsia.Additional information was requested, and received stating the iol was replaced with noncompany toric lens approximately within a month after initial procedure.
Additional Manufacturer Narrative
The explanted lens was returned in a plastic specimen cup.Solution was dried on the lens.The anterior surface of the optic had two areas between the optic central zone and the haptic/optic junction that were split and cracked.Directly opposite on the posterior surface, the optic has a small scrape mark that has a small split.A power, cylinder, and optic resolution test were attempted by engineering technician fanniro1.The lens met specification for power (19.0 diopter) and cylinder (2.25) for a company lens.The optical resolution could not be 100% confirmed due to the areas of optic damage on the returned explanted lens.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that a qualified cartridge and handpiece were used.A non-qualified viscoelastic was indicated.The root cause cannot be determined for the reported complaint.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The explanted lens was returned and evaluated.Areas of optic damage were observed.An attempted re testing of the power, cylinder, and resolution was conducted by an engineering technician.The lens met specification for power (19.0 diopter) and cylinder (2.25) for a company 19.0 diopter lens.The optical resolution could not be 100% confirmed due to the areas of optic damage on the returned explanted lens.The root cause of the observed optic damage may be due to a failure to follow the ifu(instructions for use).A non-qualified viscoelastic was indicated.The ifu instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an 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.Information was provided that the company 2.25 cyl.) 19.0 diopter was removed and replaced with a non- company toric lens 19.0 diopter.This information may suggest that the replacement lens was an improved selection for this patient's vision needs.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18894604
• Report Number: 1119421-2024-00468
• Device Sequence Number: 12300279
• Product Code: MJP
• UDI-Device Identifier: 00380652455626
• UDI-Public: 00380652455626
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2026
• Device Model Number: CCWET4
• Device Catalogue Number: CCWET4.190
• Device Lot Number: 15351763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• 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: MONARCH II LOADING FORCEPS.; MONARCH III CARTRIDGE C.; MONARCH III INJECTOR.; OCCUCOAT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown