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

Model Number	CCWTT5
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); Posterior Capsule Opacification (4807)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that the patient had an rle (refractive lens exchange) in both eyes with a company lens.After 2 months, it was noticed that the lens axis shifted from 92 to 110 after implanting the lens.Therefore, the lens was rotated back from 92 to 88 three weeks post-rotation.Additional information has been requested.There are two medical reports associated with this patient.This file belongs to left eye.
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received it states that the patient had grade 2 pco (posterior capsule opacification) at 2 months and noticed cartridge material adhered to the posterior surface of lens requiring removal with i/a (irrigation and aspiration) that can sometimes be difficult.Patient also underwent yag (yttrium-aluminum-garnet) laser capsulotomy and lens, capsule polishing.There are two medical reports associated with this patient.This file belongs to right eye.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Corrected information provided in b.2., h.6., and h.11.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury or malfunction.No further reports required.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: 21815137
• Report Number: 9612169-2025-00562
• Device Sequence Number: 18394635
• Product Code: MJP
• UDI-Device Identifier: 00380652458597
• UDI-Public: (01)00380652458597(17)260617(11)220619(10)25424199
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2026
• Device Model Number: CCWTT5
• Device Catalogue Number: CCWTT5.275
• Device Lot Number: 25424199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 04/22/2025; 06/02/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 05/16/2025; 06/25/2025
• Date Device Manufactured: 06/19/2022
• 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.; DUOVISC.; EASYCATARACT, DROPS QID.; LIDOCAINE 1%.; MONARCH II LOADING FORCEPS.; MONARCH III IOL, CARTRIDGE D.; OPHTHALMIC BETADINE 1 DROP.; PHENYLEPHRINE 1.5%.; PHENYLEPHRINE 2.5% 1 DROP.; PRED-MOXI-BROM 1%-0.5%-0.075%.; TETRACAINE 0.5%.; TROPICAMIDE 1% DROP.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male