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 Code	Visual Impairment (2138)
Date of Event	10/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.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 registered nurse reported following an intraocular lens (iol) implant procedure, the patient was bothered by shadows around objects.The lens was explanted and replaced with another lens in a secondary procedure.Additional information was received stating patient's symptoms were resolved.Patient was not hospitalized as a result of this event.
Additional Manufacturer Narrative
The product was returned for analysis.Iol received adhered to inside of zip lock bag.Solution is dried on both surfaces of the optic and haptics.One haptic is broken/torn and is adhered to the optic, the other haptic is intact.The optic is torn/split-cut dividing the iol in two and scratched/marked-rejectable.The root cause for the reported complaint could not be determined.The reported iol exchange, may suggest that the replacement lens model was an improved choice for the patient's vision needs.The ifu (instructions for use) states that it is possible to experience very bothersome visual disturbances, significant enough that the patient could request explant of the intraocular lens.Most patients implanted with the company intraocular lens are likely to experience significant loss of contrast sensitivity as compared to monofocal intraocular lens.The reporter states the use of non-company ovd (ophthalmic viscosurgical devices), this is not a qualified ovd (ophthalmic viscosurgical devices).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 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: 16060136
• Report Number: 9612169-2022-00731
• Device Sequence Number: 20516654
• Product Code: POE
• UDI-Device Identifier: 00380652405850
• UDI-Public: 00380652405850
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

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: 25289877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BARRETT TRUE K; MONARCH III, CARTRIDGE C; MONARCH III, INJECTOR; OCCUCOAT OVD; SMOOTH BLUES FORCEP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown