MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CCWTT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Vitreous Floaters (1866); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Posterior Capsule Opacification (4807)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following an age related cataract and intraocular lens (iol) implantation procedure, the patient experienced poor quality of vision, blurry vision all the ranges with no distance vision, glare from light, halos around bright light, residual astigmatism, a lot of floaters, keratoconjunctivitis sicca/some dryness, decrease contrast sensitivity and progressive worsening of vision.Some dryness prescribed artificial tears (ats) 4 times daily.Trouble with distance vision prescribed with glasses.Floaters were greatly stable.The patient had posterior capsular opacification/secondary cataract and yttrium aluminum garnet (yag) was planned.The patient was ok with readers, but reports quality of vision was limited.Surgeon discussed risk of iol exchange.The old lens was freed with viscoelastic and mobilized into the anterior chamber.The old lens was cut in half and removed without complications.Capsular bag was extended and another model same company lens with different diopter was injected with non-company capsular tension ring because of poor dilation 5 months 12 days following the initial implant procedure.Additional information has been requested.
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).

• Brand Name: CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 22353024
• Report Number: 9612169-2025-01304
• Device Sequence Number: 20814520
• Product Code: MFK
• UDI-Device Identifier: 00380652413473
• UDI-Public: (01)00380652413473(17)250409(11)211116(10)25309296
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2025

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 Expiration Date: 04/09/2025
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.115
• Device Lot Number: 25309296
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 06/30/2025
• Date Device Manufactured: 11/16/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Male