MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CCWET0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Dry Eye(s) (1814); Headache (1880); Hypersensitivity/Allergic reaction (1907); Visual Impairment (2138); Visual Disturbances (2140); Eye Pain (4467); Diplopia/Double Vision (4802)
Date of Event	11/01/2023
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 consumer reported that following an intraocular lens (iol) implant procedure, the patient experienced extreme optical pain, severe headaches, distortion, double vision, negative dysphotopsia, eyes are swollen shut, dry eyes, allergic to the lenses.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6 and h.11.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 lens remains implanted.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.The patient indicated they have seen 10 specialists and two neuro ophthalmologists without any definite diagnosis.All diagnostic testing has been clear.Patient indicated the surgeon stated the issues were related to dry eye.The patient feels they may be allergic to the lens.The surgeon was contacted.According to the surgeon, the surgeries were completed without complication.Hcp(health care professional) has explained negative dysphotopsia to patient on every visit.Patient is hyper-focused that something is wrong.Patient has seen multiple doctors in multiple specialties who have all agreed there is nothing wrong.Hcp feels patient¿s best option is to find a surgeon who will remove the lenses.Patient was going to pursue allergy testing.Information was provided on how to obtain a lens for testing.File will be reopened if the patient provides further information.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in b.5.,b6.And h.3.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received, patient had untreated strabismus prior to surgery and the surgery (not the lens) made the strabismus worse and now she needs prism in her glasses.She wishes she could keep the lens but her negative dysphotopsia was intolerable.She is having a new surgeon planned to have the lens explanted.
Additional Manufacturer Narrative
Additional information was provided in b.5.,h.3.,h.6 and h.11.New information was provided that the issues were unrelated to the iol (intra ocular lens).New information indicated that the patient had untreated strabismus prior to surgery and the surgery (not the lens) made the strabismus worse and now patient needs prism in their glasses.Information indicated that the that the patient has adapted to the lens and an explant is not planned.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 manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received and patient experienced low contrast sensitivity.Decompensated phoria was diagnosed after surgery and requiring prisms.Convergence insuffiency was also diagnosed it has improved.Patient has decided to keep the lens and not have removed.Patient has been to 27 doctors since her surgery and the current surgeon states she was adapting to lens and improving.

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS 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: 18993890
• Report Number: 1119421-2024-00573
• Device Sequence Number: 7590466
• Product Code: POE
• UDI-Device Identifier: 00380652405881
• UDI-Public: (01)00380652405881(17)260803(11)220805(10)15459515(21)15459515045
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 08/26/2024

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: 08/03/2026
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.255
• Device Lot Number: 15459515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 06/25/2024; 07/29/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 06/10/2024; 07/23/2024; 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2022
• 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