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

Model Number	CNWTT4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that after cataract surgery with intraocular lens (iol) implant, power was clearly deviated after using lens.The patient was implanted with an iol of different power.Additional information has been requested.
Additional Manufacturer Narrative
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).
Additional Manufacturer Narrative
The intraocular lens (iol) was returned for analysis and the reported complaint could not be confirmed.Iol returned attached to plastic tray.Solution is dried on the iol.One haptic is broken/torn and adhered to the optic surface with solution, the other haptic is intact.The optic is cracked/fractured and scratched/marked-rejectable.The reporter states "the patient was implanted with an iol of different power".The root cause for the reported complaint ¿explant, blurry vision distance and near" could not be determined.An impact to the visual acuity of the patient cannot be verified by examination of the returned product.Power and resolution testing could not be conducted due to the optic damage.The exchange to a lens of different power, may suggest that the replacement lens was an improved choice for the patient's vision needs based on these investigation findings, we are unable to verify if the iol contributed to the event.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: 19786965
• Report Number: 9612169-2024-00718
• Device Sequence Number: 8428659
• Product Code: MJP
• UDI-Device Identifier: 00380652469159
• UDI-Public: (01)00380652469159(17)250301(11)211008(10)25281043(21)25281043007
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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 Expiration Date: 03/01/2025
• Device Model Number: CNWTT4
• Device Catalogue Number: CNWTT4.245
• Device Lot Number: 25281043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 07/20/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown