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

Model Number	CNWTT5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	11/21/2022
Type of Reportable Event	Serious Injury
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.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 after a cataract extraction with intraocular lens (iol) implant procedure, the patient experienced poor postoperative results and visual acuity was not good for both uncorrected va and corrected va and it was difficult to see after surgery.The iol was explanted and exchanged in a secondary procedure for non-company lens.Additional further information requested.
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint could not be confirmed.Iol returned in unknown cartridge.The iol is cut in two inside the device, the optic is bent/deformed.One haptic is broken/torn and is returned adhered to the tip of the cartridge, the other haptic is attached to the optic.Solution is dried on both surfaces of the optic and haptics.Unable to perform power and resolution testing due to the condition of the returned iol.No root cause identified as the reported complaint "poor postoperative results" could not be confirmed.Unable to perform power and resolution testing due to the condition of the returned iol.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: 16564528
• Report Number: 9612169-2023-00224
• Device Sequence Number: 5691493
• Product Code: MJP
• UDI-Device Identifier: 00380652469418
• UDI-Public: 00380652469418
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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: 02/05/2025
• Device Model Number: CNWTT5
• Device Catalogue Number: CNWTT5.110
• Device Lot Number: 25267268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2021
• 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 MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; HEALON.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; SYNERGY T225.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male