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

Model Number	SY60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Diplopia/Double Vision (4802)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, problems with halos and starburst.These problems have made it very difficult to night drive.The patient has seen physician numerous times over the year.The physician has performed a 'yag' procedure to eliminate the 'secondary cataract' in hopes that it would resolve the problem.However, the symptoms were continuing, and consumer have informed to physician that it seems to me that the lens is moving in eye as consumer can see the movement (my pulse for example).This is most noticeable if i tilt my head to the side.The physician dismissed my claim and stated i was seeing a shadow but not the case.The patient has asked if the lens is designed with concentric circles on the surface as i see these circles in the glare from overhead light.The physician informed me that it does not.The consumer unable to work in an office with overhead lights due to glare/halos and unable to comfortably watch tv (television) in home with overhead lights on.The patients concern that i was to have my right eye cataract lens done as well, which will help with the vision differences between the two.When i brought this up to my physician, he said it seems like i have adjusted to the difference.Consumer has changed his perspective on going ahead with a lens replacement in right eye.Additional information has been requested.
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.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.The company lens is a monofocal lens and does not have "rings".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.The reporter was the patient.Permission was not given to contact the hcp.File will be reopened if new information is provided.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC 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: 18629817
• Report Number: 1119421-2024-00180
• Device Sequence Number: 12734905
• Product Code: HQL
• UDI-Device Identifier: 00380652251419
• UDI-Public: 00380652251419
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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 Expiration Date: 02/19/2025
• Device Model Number: SY60WF
• Device Catalogue Number: SY60WF.165
• Device Lot Number: 15273955
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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; Required Intervention
• Patient Sex: Male