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 Codes	Failure to Advance (2524); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
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 that during a cataract extraction with an intraocular lens (iol) implant procedure, lens became stuck in the cartridge and the insertion device scuffed the lens.There was patient contact observed.The surgery was completed the same day with another lens.Additional information was received stating no harm was done to the patient.
Additional Manufacturer Narrative
Additional information was provided in d.9, h.3, h.6 and h.10.The product was returned for analysis and damage was observed to the intraocular lens.No cartridge was returned.Intraocular lens returned pressed against one post of the lens case base resulting in damage to the intraocular lens.A significant amount of solution is dried on both surfaces of the optic and haptics.One haptic is adhered to the optic with solution, the other haptic is bent/deformed.The optic is cracked/fractured and scratched/marked-rejectable.Unable to conduct dimensional testing due to condition of returned sample.No cartridge received.The product investigation could not identify the root cause for the reported complaint "lens became stuck in the cartridge" as only the intraocular lens was returned for evaluation.Due to this, we are unable to complete a thorough investigation to determine a root cause.Investigation has been completed based on current information.No further action is warranted at this time.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: 16069124
• Report Number: 9612169-2022-00738
• Device Sequence Number: 20416482
• Product Code: POE
• UDI-Device Identifier: 00380652405850
• UDI-Public: 00380652405850
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2025
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.240
• Device Lot Number: 25289876
• 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: 12/08/2022
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 04/21/2023
• 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: CLAREON MONARCH IV, INJECTOR; MONARCH III, CARTRIDGE D; UNSPECIFIED LOADING FORCEPS; VISCOAT
• Patient Sex: Unknown