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); Flashers (1864); Vitreous Floaters (1866); Foreign Body Sensation in Eye (1869); Blurred Vision (2137); Visual Disturbances (2140); Excessive Tear Production (2235); Discomfort (2330); Eye Pain (4467); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that following an intraocular lens (iol) implant procedure, on (b)(6) 2023 the patient went for clear lens evaluation and complained of blurred vision in both eyes.On (b)(6) 2023 post operative visit patient had noticed foreign body sensation , microcystic edema and photophobia.On (b)(6) 2023 the patient noticed blurred vision, flashes, shadow, foreign body sensation, peripheral in affected eye.On (b)(6) 2023 visit observed noticed blurred vision and photophobia.On (b)(6) 0.2mm temp plugs post lasik.The patient complaints that eyes felt tired.On (b)(6) 2023 noticed irritation in eye , tearing, light sensitivity and blurry vision given treatment with lotemax.On (b)(6) 2023 patient had dry eyes and posterior capsular opacification.On (b)(6)2023 the iol was exchanged for another lens model one month following the initial implant procedure.Clinical reason for explant was residual astigmatism.After surgery patient able to do all work without glasses.This report is associated with the left eye.Additional information has been requested.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

• 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: 17451571
• Report Number: 1119421-2023-01383
• Device Sequence Number: 7416041
• Product Code: POE
• UDI-Device Identifier: 00380652405751
• UDI-Public: 00380652405751
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2023

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: 01/26/2026
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.190
• Device Lot Number: 15346429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• 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: ARGOS BIOMETER; CARTRIDGE D; CLAREON MONARCH IV; HEALON DUET; ORA
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 55 YR
• Patient Sex: Male