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

Model Number	CNWTT3
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The toric lens was returned positioned incorrectly in the replacement lens case inside the replacement lens carton (company 20.0 diopter).Solution and blood was observed on the lens.The toric axis marks were observed.The optic was cut into multiple portions.Not all optic portions were returned.The lens has been replaced into the replacement lens case incorrectly, resulting in additional optic damage and a broken, smashed distal area to one haptic.The optic portions have additional cracked and torn areas.The power (sphere and cylinder) and optical resolution cannot be re-evaluated due to the extensive lens damage.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge, handpiece, and viscoelastic combination was indicated.The explanted lens was returned cut into pieces, typical of an insertion and removal.Additional lens damage was observed.The root cause cannot be determined for the reported complaint.A facility representative reported an explanted iol with patient reason vision compromised by dislocated iol.Clinical reason given was zonules/bag unable to support single piece toric iol.Each lens was subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine qee acceptability per the lens model and diopter.The power (sphere and cylinder) and optical resolution of the returned lens could not be re-evaluated due to the optic damage.The company (1.50 cyl.) 20.0 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with an company 20.0 diopter lens.The information provided in the file of patient's zonules/bag unable to support single piece toric would support that the replacement lens model and diopter was an improved selection for this patient's vision needs.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 vision was compromised by dislocated iol.The lens was exchanged for another lens model 4 months following the initial procedure.Clinical reason for explant was mentioned as weak zonule / bag which did not support single piece toric lens.Additional information has been requested.
Additional Manufacturer Narrative
Correction information provided in d.9.

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC 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: 19519641
• Report Number: 1119421-2024-01135
• Device Sequence Number: 15059033
• Product Code: MJP
• UDI-Device Identifier: 00380652468534
• UDI-Public: 00380652468534
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 07/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CNWTT3
• Device Catalogue Number: CNWTT3.200
• Device Lot Number: 15564181
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/30/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• 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: ACRYSOF IQ RESTOR MULTIPIECE IOL.; CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; MONARCH II LOADING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown