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

Model Number	CCW0T4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Pain (4467)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.It remains implanted in the patient's eye.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A consumer reported that she wanted a blue light filtering lens to be implanted in her eye.But, a company representative convinced her doctor that a uv only lens was blue light filtering lens and it was implanted in her eye.The consumer stated she had tired eye after working on computer.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
D.3.Product manufacturing site updated due to receipt of product serial number g.9.Manufacturer report number corrected and reported under 1119421-2023-01710 product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause.The patient complains of their eye getting tired after working at a computer.The patient wants to have a lens replaced with one that has blue light filtering.The file will be reopened if additional information is provided.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received.According to the surgeon there was a misunderstanding between the surgeon and the company representative.The surgeon spoke with the company sales representative about the patient¿s desire for a blue-filtering lens.After that conversation, the surgeon believed that the company lens would meet the patient¿s needs for blue-filtering.The patient preferred a lens with a blue blocking filter.According to the surgeon the prognosis was excellent.The patient had excellent outcome with the toric lenses.At the final post-op visit, patient expressed concern to the surgeon of having an intraocular lens ( iol) with blue blocking filter in the left eye only and not the right eye.The surgeon discussed with the patient that there is no evidence of the iol¿s without the blue blocking filter causing harm to the eye and also discussed of iol exchange in patient's right eye.The surgeon felt that the risks outweighed the benefits and offered the patient a second opinion with a colleague.The patient did not follow through with this.The patient sought a second opinion elsewhere and that surgeon also felt the risks outweighed the benefits.The lens remains implanted.

• Brand Name: CLAREON TORIC UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; model farm road; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; model farm road; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16687807
• Report Number: 9612169-2023-00268
• Device Sequence Number: 6112011
• Product Code: MJP
• UDI-Device Identifier: 00380652432894
• UDI-Public: 00380652432894
• Combination Product (Y/N): N
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2023
• 2 Devices were Involved in the Event: 1 2

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: 05/14/2026
• Device Model Number: CCW0T4
• Device Lot Number: 15409478
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 09/12/2023; 11/08/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 10/06/2023; 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female