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	Blurred Vision (2137)
Date of Event	12/07/2023
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 waxy vision and overall poor quality vision.The iol was exchanged for unspecified lens.Clinical reason for explant mentioned as physician's decision.Additional information has been requested.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested, received and stated patient complained of foggy vision since post operative week#3.Reassurance and handholding provided.Photorefractive keratectomy (prk) performed at post operative meeting#6 for residual +0.50.Posterior capsule clear, objective scatter index (osi) elevated.Vision did not improve, patient reported vision foggy at distance and near.The patient issues resolved post secondary lens explantation.
Additional Manufacturer Narrative
Additional information provided in h.11.The explanted 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 indicated a photorefractive keratectomy (prk) was performed on the eye at the six month post operation appointment with no improvement in the patient vision, therefore an explant was performed.The company 23.0 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a company different model 25.0 diopter lens.Due to the exchange of a multifocal 23.0 diopter lens for a monofocal 25.0 diopter lens, this suggests that the replacement lens may have been an improved choice for the patient vision needs.Also, an intraocular lens (iol) exchange for a difference equal to or greater than two diopters, indicates the event is most likely related to a calculation error.Based on the information provided, the event does not appear to be related to the product.Per the completed questionnaire, after the lens exchange, the patient vision issues have resolved.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: 20237610
• Report Number: 1119421-2024-01821
• Device Sequence Number: 18153271
• Product Code: MFK
• UDI-Device Identifier: 00380652413701
• UDI-Public: (01)00380652413701(17)260716(11)220718(10)15450188(21)15450188076
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2024

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: CCWTT0.230
• Device Lot Number: 15450188
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 09/18/2024; 10/31/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/15/2024; 11/28/2024
• 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: CLAREON MONARCH IV IOL INJECTOR.; MONARCH II LOADING FORCEPS.; MONARCH III IOL CARTRIDGE D.; REPLACEMENT: UNSPECIFIED LENS.; VISCOAT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female