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

Model Number	CNWTT3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non healthcare professional reported that, during intraocular lens implantation surgery, there was a tear in the lens.Hence the lens was explanted and replaced with another lens in the same procedure.There was no patient harm.
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was observed.Intra ocular lens (iol) returned in two pieces (cut/split in half) in the lens case.A significant amount of solution is dried on the iol.Both haptics are broken/torn and not returned.The optic is torn/split-cut dividing the iol in two and cracked/fractured and scratched/marked-rejectable with a piece missing.The complainant indicates the use of company cartridge, which is not qualified for use with associated iol diopter.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow the company instruction of company qualified iol delivery system product combinations and alternative viscoelastic.The use of nonqualified combinations may result in delivery issues and/or damage.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 HYDROPHOBIC 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: 18308378
• Report Number: 9612169-2023-00890
• Device Sequence Number: 6643898
• Product Code: MJP
• UDI-Device Identifier: 00380652468671
• UDI-Public: 00380652468671
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNWTT3
• Device Catalogue Number: CNWTT3.270
• Device Lot Number: 25601450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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: DISCOVISC.; MONARCH CARTRIDGE D.
• Patient Age: 71 YR
• Patient Sex: Female