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

Model Number	CCWTT3
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	12/17/2024
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-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurred vision.Clinical reason for explant was mechanical complication.The iol was exchanged for advanced technology intraocular lenses (atiol) model lens 1 months 5 days following the initial implant procedure.There was no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned inside a specimen jar with a medical swab.Viscoelastic was observed on the lens.The lens was cleaned with keratoconus related limbal ring parameters for further evaluation.After removal of the dried viscoelastic, the lens was evaluated.No damage was observed.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified cartridge, handpiece and viscoelastic were used.The product investigation could not identify a root cause for the reported complaint of blurred vision (explant).The lens was returned and evaluated.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 power (sphere and cylinder) and resolution of the returned lens was retested and verified.The lens met specification for power and resolution for a company lens (1.50 cylinder) 22.0 diopter (add power +2.2/+3.2 diopter).The company lens (1.50 cylinder) 22.0 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a noncompany 21.5 diopter lens.Due to the exchange of a toric multifocal 22.0 diopter lens for a lens that is one half less in diopter, this suggests that the replacement lens may have been an improved choice for the patient's vision needs.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 21445220
• Report Number: 1119421-2025-00490
• Device Sequence Number: 7724308
• Product Code: MJP
• UDI-Device Identifier: 00380652457422
• UDI-Public: (01)00380652457422(17)280420(11)240422(10)15840088
• 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): 03/25/2025

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 Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.220
• Device Lot Number: 15840088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; REPLACEMENT LENS S/N : (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female