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	Foreign Body Sensation in Eye (1869); Blurred Vision (2137)
Date of Event	09/22/2022
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 after intraocular lens (iol), the patient had foreign body sensation and hazy blurred vision.The lens was explanted and replaced with another multifocal lens within one month of the initial procedure.The clinical reason was explant was reported as mechanical complication of intraocular lens.The patient's symptoms were resolved after replacement of lens.
Additional Manufacturer Narrative
Correction information was provided in b.7.Additional information was provide in h.3., h.6.And h.10.The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified associated products were used.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Each lens is 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.Information was provided that the company's, 16.0 diopter lens was exchanged for a company's, 17.5 diopter lens.The exchange for the same model with a 1.5 diopter difference may indicate the 17.5 diopter better met the patient's visual needs.The hcp provided information that the patient¿s issues have resolved.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: 16092890
• Report Number: 1119421-2023-00026
• Device Sequence Number: 6511839
• Product Code: HQL
• UDI-Device Identifier: 00380652396745
• UDI-Public: 00380652396745
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023

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: 02/15/2026
• Device Model Number: CC60WF
• Device Lot Number: 15354377
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female