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

Model Number	CC60WF
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	12/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A non health care professional reported that following the intraocular lens implantation the patient had trouble adjusting to lens and was unhappy with the vision.The iol was explanted and replaced with another lens following the initial procedure.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned on a sticky label placed on the interior of a sealed non-company pouch.Solution and blood was dried on the lens.The optic was cut into pieces.The optic edge has two areas of the edge that were split, beginning at the edge and travelling inward on the optic.One haptic/optic junction was split on the gusset edge.This split damage travelled down into the optic.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge, handpiece, and viscoelastic.The root cause cannot be determined for the reported complaint.The explanted lens was returned in pieces, typical of damage created to remove a lens from the eye.Each lens was subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.Additional lens damage was also observed.Information was provided that indicated the monofocal company 25.5 diopter lens was removed and replaced with a non-company monofocal lens that was 24.0 diopters.This information that another monofocal lens model with 1.5 diopters difference may suggest that the complaint was potentially not lens related, and the replacement lens was an improved selection for this patient's vision needs.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC UV ABSORBING IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 18130001
• Report Number: 1119421-2023-01890
• Device Sequence Number: 6439622
• Product Code: HQL
• UDI-Device Identifier: 00380652396936
• UDI-Public: 00380652396936
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2023

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: 06/28/2026
• Device Model Number: CC60WF
• Device Lot Number: 15431442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• 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: DISCOVISC.; MONARCH III INJECTOR.; MONARCH III IOL CARTRIDGE D.; ORA SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female