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

Model Number	CCWTT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that after intraocular lens (iol) implantation, the patient could not adapt to the multifocal lens implanted.The lens was removed and replaced with a monofocal lens in a secondary procedure.Additional information was received.According to the surgeon the iol did not contribute to the event, the patient simply couldn't adapt to the multifocal lens.A non-company lens was used as replacement.
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 product was not returned for analysis.The root cause for the reported complaint appears to be a coincidental event that was unrelated to the product as user facility reported that according to the surgeon, the intraocular lens (iol) did not cause the event.The event was related to the patent not being able to adapt to the multifocal lens.Based on this information, the device did not cause/contribute 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 TRIFOCAL UV ABSORBING 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: 18408582
• Report Number: 9612169-2023-00953
• Device Sequence Number: 2932851
• Product Code: MFK
• UDI-Device Identifier: 00380652413510
• UDI-Public: 00380652413510
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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: 09/13/2026
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.135
• Device Lot Number: 25481842
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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: ANIKAVISC; MONARCH III CARTRIDGE D; MONARCH III INJECTOR; SMOOTH FORCEPS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown