MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. 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	Vitreous Floaters (1866); Intraocular Pressure Increased (1937); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non healthcare professional reported following implantation of intraocular lens, patient had double monocular vision producing ghosting on the medial side of vision.Additional information was received and stated with post operative check on the day of surgery, patient had extreme intraocular pressure (iop) increased and required burping only during the same day.Right eye focus is not sharp due to the ghosting and doughnuts, and can make out the letters with at 20/20 with great difficulty.Right eye has multiple doughnut shaped floaters.Right eye symptoms remain unchanged since day after implant.The surgeon used the laser to make the cuts in the cornea, correct slight astigmatism in both eyes and break up the cataract.There are two medical device reports associated with this patient.This report is associated with the right eye.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received stating immediate massive increase in iop (70 range) with lots of small round black circles with clear centers was noted.Left with monocular double vision (about 10% overlay) in each eye and double vision with both eyes open.The double vision is very distracting and hard to focus, white seems to make the double vision more noticeable.There are two medical device reports associated with this patient.This report is associated with the right eye.

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15957031
• Report Number: 9612169-2022-00684
• Device Sequence Number: 5549544
• Product Code: POE
• UDI-Device Identifier: 00380652405850
• UDI-Public: 00380652405850
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2023

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: 03/21/2025
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.240
• Device Lot Number: 25289879
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male