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

Model Number	CCWTT3
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was returned for analysis.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 materials manager reported that during a cataract extraction with an intraocular lens (iol) implant procedure, they found smudged lens and it was removed by irrigation and aspiration.Additional information was received stating the lens was explanted.
Additional Manufacturer Narrative
The intraocular lens was returned for analysis and the reported complaint was not observed.Photo was provided showing the reported "smudges" on the lens.No cartridge was returned.Intraocular lens returned in a plastic container in an unknown solution.Intraocular lens is air dried.Solution is dried on the intraocular lens.Intraocular lens is partially cut through the centre of the optic.There is a crack/fraction on both surfaces of the intraocular lens.Cracks are right above each other.No foreign material or the reported ''smudge'' observed.Photo provided shows an implanted intraocular lens on a monitor screen.There appears to be a mark/material on the intraocular lens, the exact location of the mark/material (anterior or posterior intraocular lens surface) cannot be confirmed.The complainant indicates the use of non-company as a viscoelastic.Non-company viscoelastic is not qualified for use with company model.Based on our observation of the attached photo, a mark/material was observed on the implanted intraocular lens.The reported mark/material was not observed on the returned intraocular lens.The cartridge was not returned for analysis.A final root cause cannot be determined based on available information and without the evaluation of the physical sample of material.The surgeon states the use of non-qualified viscoelastic.The use of an unqualified combination may cause damage to the intraocular lens and potential complications during the implantation process.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: 15678886
• Report Number: 9612169-2022-00555
• Device Sequence Number: 20323797
• Product Code: MJP
• UDI-Device Identifier: 00380652457279
• UDI-Public: 00380652457279
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2026
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.145
• Device Lot Number: 25415426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male