MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON 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	Blurred Vision (2137); Halo (2227)
Date of Event	01/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced severe halos affecting activities of daily living.Clinical reason for explant cannot tolerate halos and waxy vision.The iol was exchanged for another model company lens 18 days following the initial implant procedure.Additional information has been requested.There are two medical device reports associated with this patient.This report is second report associated with the one of the eye.
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).
Additional Manufacturer Narrative
Correction information was provided in d.4.Additional information was provided in a.2., a3.A., b.3., b.5., b.6, d6a., d6b., d.10., h.3., and h.11.The product was not returned.Product history records were reviewed, and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause.The lens was not returned.Each lens is subjected to a 100 percentage assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the company, 20.5 diopter (add power +2.2/+3.2) lens was replaced with an unspecified extended depth of focus lens.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).
Event or Problem Description
Additional information has been requested and received stating the patient experienced poor near and distance vision.The iol was exchanged for different model company lens with unspecified diopter 4 months 26 days following the initial implant procedure.The surgeon¿s prognosis was good.The patient issues was resolved.There are two medical device reports associated with this complaint.This report is 2/2.

• Brand Name: CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 20189703
• Report Number: 1119421-2024-01782
• Device Sequence Number: 8091923
• Product Code: MFK
• UDI-Device Identifier: 00380652413657
• UDI-Public: (01)00380652413657(17)271203(11)231205(10)15757872(21)15757872091
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/17/2024

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 Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.205
• Device Lot Number: 15757872
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 10/17/2024
• Date Device Manufactured: 12/05/2023
• 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: ACRYSOF IQ VIVITY EXTENDED VISION IOL; DUOVISC VISCOELASTIC SYSTEM; UNSPECIFIED LENS LOADER
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 55 YR
• Patient Sex: Male