MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWTT6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Halo (2227)
Date of Event	07/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Product history records were reviewed, and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that following a cataract extraction with intraocular lens (iol) implant procedure, the patient experienced blurred va at all distances, halos, and ghosting of letters when reading.The lens was explanted in a secondary procedure approximately 4 months after initial implantation.The lens was replaced with a monofocal lens.Additional information received stating there was no patient harm.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge and, handpiece.A non-qualified viscoelastic was used.The product investigation could not identify a root cause for the reported complaint of "explant, blurred va at all distances, halos, ghosting of letters".The file indicated that the explanted lens will not be returning.The file indicated that the company toric (3.75 cyl.) 16.0 diopter (1.5 extended depth of focus) lens was removed and replaced with a non-company 16.0 diopter monofocal lens.This information that a toric lens was replaced with a monofocal lens may suggest that the replacement lens was an improved selection for this patient's vision needs.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 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: 16082534
• Report Number: 1119421-2023-00006
• Device Sequence Number: 15086259
• Product Code: MJP
• UDI-Device Identifier: 00380652458894
• UDI-Public: 00380652458894
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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: 01/10/2026
• Device Model Number: CCWTT6
• Device Catalogue Number: CCWTT6.160
• Device Lot Number: 15332717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 01/29/2023
• Initial Report FDA Received Date: 01/02/2023
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• 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 IV IOL INJECTOR; MONARCH III , CARTRIDGE D; OCCUCOAT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female