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

Model Number	CCWTT5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Glaucoma (1875); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that after intraocular lens (iol) implantation procedure, the patient was intolerant to the lens.The lens was removed and replaced with a monofocal lens in a secondary procedure.The clinical reason for explant were miosis and narrow angles.Additional information was requested and received.The patient additionally experienced blurry vision at both distance and near with the initial implant.Expressing discontent with the visual acuity provided by the initial implant, the patient reported that nothing was clear to him.According to the surgeon's opinion, the iol did not contribute to the patient's experiences.
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 reporter stated the intraocular lens (iol) was "explanted iol with reason company lens intolerance.Clinical reason for explant: miosis / narrow angles.Replaced with monofocal." 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 iol did not cause the event.The reporter stated the iol was explanted with reason company lens intolerance.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 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: 18993658
• Report Number: 9612169-2024-00265
• Device Sequence Number: 18040052
• Product Code: MJP
• UDI-Device Identifier: 00380652458337
• UDI-Public: 00380652458337
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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 Model Number: CCWTT5
• Device Catalogue Number: CCWTT5.145
• Device Lot Number: 25507431
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2022
• 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: BAUSCH AND LOMB - CLEARVISC; KATENA CURVED TYING FORCEPS; MONARCH III INJECTOR; MONARCH III CARTRIDGE D
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male