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	03/05/2024
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 blurry vision at all distances.The iol was exchanged for another lens model 7 months and 10 days after the initial implant procedure.Additional information has been received and stated that the patient experienced hyperopic miss.No patient harm was reported.
Additional Manufacturer Narrative
The lens was returned adhered to a piece of white medical sponge material in a plastic bag.Viscoelastic was observed on the lens.The optic was cut into pieces, typical of an insertions and removal.The optic posterior and anterior surfaces have parallel lines of cracked optic damage similar in appearance to damage from an instrument used to grasp the lens.Product history records were reviewed, and documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge and handpiece with a non qualified viscoelastic.The root cause cannot be determined for the reported complaint.The lens was returned cut into pieces, typical of an insertion and removal.Each lens was 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.The power and resolution of the returned lens could not be re evaluated due to the optic damage.Information was provided that the company model 20.0 diopter (add power plus2 point 2 or plus 3 point 2 diopter) was removed and replaced with a non company monofocal 20.0 diopter lens.Due to the exchange of a multifocal for a monofocal, this suggests that a monofocal lens may have been an improved choice for the patients vision needs.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: 20451677
• Report Number: 1119421-2024-02014
• Device Sequence Number: 20584925
• Product Code: MFK
• UDI-Device Identifier: 00380652413640
• UDI-Public: (01)00380652413640(17)270626(11)230628(10)15671420
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 10/15/2024

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: CCWTT0.200
• Device Lot Number: 15671420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; OCUCOAT; REPLACEMENT LENS L161A0 20.0DIOPTER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male