MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWTT4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.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 reason as intolerable halos and clinical reason for explant being persistent dysphotopsias, patient dissatisfied with visual disturbances.The iol was explanted and exchanged for an unknown atiol following the initial implant procedure.Additional information has been requested and received stating that the patient noted seeing halos in daylight and at night, passing under a light sees a reflection of the light.Intermediate vision was h around words and letters up close.Nighttime driving was very difficult lights tend to fuse together into a smeary blob.As per surgeon's opinion, product caused intractable dysphotopsias.The iol was explanted and exchanged for with a different model but same diopter company lens following the initial implant procedure.
Additional Manufacturer Narrative
The product was not returned for analysis.Company lens with 13.0 diopter was replaced with a same company lens but a different model with same diopter (13.0).The reporter states the use of non company as a viscoelastic which is not qualified for use with associated.The root cause for the reported complaint could not be determined.The exchange to a same company lens , may suggest that the replacement lens model was an improved choice for the patient vision needs.The ifu states that some visual effects may be expected due to the superposition of focused and unfocused multiple images.These may include some perception of halos, radial lines around point sources of light(starbursts) under night-time conditions, or glare, as well as other visual symptoms.As with other multifocal iols, there is a possibility that visual symptoms may be significant enough that the patient will request explant of the multifocal iol.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19691093
• Report Number: 9612169-2024-00665
• Device Sequence Number: 20926775
• Product Code: MJP
• UDI-Device Identifier: 00380652457774
• UDI-Public: (01)00380652457774(17)261009(11)221011(10)25507414(21)25507414100
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 10/02/2024

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: CCWTT4
• Device Catalogue Number: CCWTT4.130
• Device Lot Number: 25507414
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 10/02/2024
• Date Device Manufactured: 10/11/2022
• 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: AMVISC OVD.; CLAREON MONARCH IV IOL INJECTOR.; CLAREON VIVITY TORIC EXT. VISION UV ABSORB IOL.; MONARCH II LOADING FORCEPS.; MONARCH III IOL CARTRIDGE D.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male