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); Visual Impairment (2138)
Date of Event	06/19/2024
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 stated ability to read was okay but distance vision was not good.Unable to read road signs or see tv.The iol was exchanged for non-company lens.Clinical reason for explant mentioned as non-adapt.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 holder.Viscoelastic was dried on the lens.The optic was cut into two portions.One optic was torn near a haptic/optic junction beginning at the optic edge and travelling to the outer rings.The optic edge was broken.The broken portion of the lens was not returned.This optic portion has parallel lines of cracked damage from the edge into the optic rings on the posterior and directly above on the anterior in the shape of an instrument used to grasp the lens.The other optic portion has a line of cracked damage near the optic center and two separate small areas that are cracked.The posterior optic has parallel lines of cracked damage from the edge toward the center of the optic rings on the posterior and directly above on the anterior in the shape of an instrument used to grasp the lens.Product history records were reviewed and documentation indicated the product met release criteria.The cartridge information was not provided.It is unknown if a qualified cartridge was used.A handpiece was indicated that would be qualified if used with a qualified lens/cartridge combination.A viscoelastic was indicated that is not qualified for any company lens/cartridge combinations.The root cause could not be determined for the reported visual issues.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.Information was provided that the clinical reason for the explant was non-adaption to the multifocal lens.The 22.0 diopter (add power +2.2/+3.2 diopter) lens was replaced with a non-company monofocal of the same diopter.This information that the multifocal lens was exchanged for a monofocal lens would suggest that a monofocal lens was an improved selection for this patient's vision needs or preferences.File will be reopened if new information 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: 20201266
• Report Number: 1119421-2024-01792
• Device Sequence Number: 7676144
• Product Code: MFK
• UDI-Device Identifier: 00380652413688
• UDI-Public: (01)00380652413688(17)210803(11)210803(10)15245157(21)15245157058
• 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: 2023
• 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: 12/25/2024
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.220
• Device Lot Number: 15245157
• 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: 08/03/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMVISC; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; MONARCH III IOL INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female