MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON TORIC UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCW0T6
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	02/15/2024
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A non-healthcare professional reported that the lens was implanted but turned out to be the incorrect lens power for the patient, the measurements were off causing a refractive miss.The lens was exchanged for another lens model 08 days following the initial procedure.Additional information has been requested.
Additional Manufacturer Narrative
Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury.No further reports required.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
Additional information received and reported that the iol (intra ocular lens) was exchanged for the same lens model but one diopter more power indicating the correct lens power was not implanted initially.There is no reported defect or fault with the iol.

• Brand Name: CLAREON TORIC UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19454519
• Report Number: 1119421-2024-01055
• Device Sequence Number: 7106706
• Product Code: MJP
• UDI-Device Identifier: 00380652435017
• UDI-Public: (01)00380652435017(17)270201(11)230203(10)15577276(21)15577276014
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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: CCW0T6
• Device Lot Number: 15577276
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 08/12/2024
• Date Device Manufactured: 02/03/2023
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; UNSPECIFIED IMPLANTATION/FOLDING FORCEPS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male