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 Code	Visual Impairment (2138)
Date of Event	07/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device 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).
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient had residual refractive error.The iol was exchanged for unspecified lens.Clinical reason for explant mentioned as residual astigmatism.Additional information has been requested.
Event or Problem Description
Additional information has been requested, received and stated there was no lens explant/exchange happened to the patient and was tentatively scheduled.According to surgeon opinion there was no issue with the iol, but it was measurements issue.
Additional Manufacturer Narrative
Correction information provided in d.4.Additional information provided in b.2., b.3., b.5., b.6., d.10.And h.11.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury.As per the surgeons opinion there was no issue with the intraocular lens (iol), but it was measurements issue.No further reports required.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 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: 20267559
• Report Number: 1119421-2024-01877
• Device Sequence Number: 11639118
• Product Code: MFK
• UDI-Device Identifier: 00380652413459
• UDI-Public: (01)00380652413459(17)270103(11)230105(10)15546766(21)15546766084
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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: CCWTT0.105
• Device Lot Number: 15546766
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/17/2024
• Date Device Manufactured: 01/05/2023
• 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: ARGOS BIOMETER.; MONARCH III IOL INJECTOR.; PROVISC.; REPLACEMENT UNSPECIFIED LENS.; UNSPECIFIED CARTRIDGE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown