MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CNWTT0
Medical Device Problem Codes	Defective Device (2588); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and 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 physician reported that following an intraocular lens (iol) implant procedure, an unusual aspect to the posterior circumference of the iol was noted.The implant was left in the eye as no visual impact was expected.Additional information has been requested.
Additional Manufacturer Narrative
Additional information provided in a.1., a2., a.3.,b.3, b.5., b.6.,d.10., e.4., h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating unusual aspect to the posterior circumference of the iol feathered appearance of circumferential posterior optic edge as though there was micro debris adherent to it.Scheduled procedure was completed on same day and event occurred during surgery.There was no patient harm reported.
Additional Manufacturer Narrative
The product was not returned for analysis.One photo received, there appears to be material adhered to the edge of the optic.No confirmation can be made what type of material or the origin of the material.Video received.Lens preparation is not shown.The nozzle comes in to view, the haptics appears to be in the correct position as the iol passes out of the nozzle.The iol unfolds in the eye, there appears to be some material adhered to the optic edge.No confirmation can be made what type of material or the origin of the material.Based on our observation of the photo, a material is observed on the iol optic which could potentially be a material adhered to the edge of the lens.A definitive determination of the reported complaint cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 15697098
• Report Number: 9612169-2022-00560
• Device Sequence Number: 17987992
• Product Code: MFK
• UDI-Device Identifier: 00380652407861
• UDI-Public: 00380652407861
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2026
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.070
• Device Lot Number: 25340956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 11/04/2022; 12/15/2022
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 12/03/2022; 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• 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: BARRETT II UNIVERSAL, HOLLADAY 2; MONARCH , INJECTOR; MONARCH III CARTRIDGE D; PROVISC
• Patient Age: 73 YR
• Patient Sex: Female