MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWET6
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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.Photo review- photo shows an implanted iol, the axis markings appear to be misaligned in relation to one haptic junction, the other haptic junction is not visible the manufacturer internal reference number is: (b)(4).
Event or Problem Description
An ophthalmic surgeon reported that during a cataract extraction with intraocular lens (iol) implant procedure, the toric markings are not in place where it was expected, and the patient vision was not clear.Additional information has been requested.
Additional Manufacturer Narrative
The root cause is deemed to be manufacturing related (root cause most probably relates to human factors where milling machine prompt for realignment was not executed as per procedure).The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 16180288
• Report Number: 9612169-2023-00057
• Device Sequence Number: 11338695
• Product Code: MJP
• UDI-Device Identifier: 00380652456418
• UDI-Public: 00380652456418
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023

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: 03/07/2026
• Device Model Number: CCWET6
• Device Catalogue Number: CCWET6.225
• Device Lot Number: 25370001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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
• Patient Sex: Unknown