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	04/25/2024
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 had limitations in vision (os).The iol was exchanged for non-company lens.There was no patient harm.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).
Additional Manufacturer Narrative
The lens was returned inside a non-company rotary lens case.Viscoelastic was dried on the lens.One haptic was bent upon return.The lens was creased from the lens case.The lens was cleaned with klrp for further evaluation.The posterior optic surface was scratched and scraped across the optic rings.One line of scraped ring damage was also gouged.Product history records were reviewed and documentation indicated the product met release criteria.Information was provided that a qualified cartridge and handpiece were used with a non-qualified viscoelastic.The root cause cannot be determined for the reported complaint of limitations in vision.The explanted lens was evaluated.Multiple areas of damage to the optic rings was observed.Each lens was 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 and resolution of the returned lens could not be re-evaluated due to the optic damage.The 21.5 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a non-company monofocal 21.5 diopter.This information that a multifocal lens was exchanged for a monofocal lens would suggest that the replacement lens was an improved selection for this patient's vision needs.File will be reopened if new information or the sample is received.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: 20198527
• Report Number: 1119421-2024-01786
• Device Sequence Number: 7583567
• Product Code: MFK
• UDI-Device Identifier: 00380652413671
• UDI-Public: (01)00380652413671(17)260716(11)220718(10)15456023(21)15456023010
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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: 07/16/2026
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.215
• Device Lot Number: 15456023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2022
• 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: HEALON VISCOELASTIC; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; REPLACEMENT LENS: ZCB00 21.5, SN (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male