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

Model Number	CCWET3
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced blurry vision.The distance vision was bad was unable to read street signs or captions on tv and not comfortable driving due to the poor vision.The lens requires repositioning.The surgeon said that poor vision was due to age and other ophthalmologist disagree and said the incorrect lens was implanted as the patient has history of vision sensitivity standard distance toric lens should be implanted rather than an extended focus lens.The patient was advised changing the lens.The patient was diligent about hydrating eyes with drops at least 4x per day.Vison was a solid 20/10 in both eyes until about age 72 and was corrected to 20/25 which is better than the new iol.There are two medical device reports associated with this file.This report is associated with the left eye.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received that the ophthalmologist said that the problem was the brain adapting to the company model lens.Additional information received that long distance vision in both eyes was exceptional.But vision was blurry while driving.
Additional Manufacturer Narrative
The product was not returned for analysis.The root cause for the reported complaint could not be determined.Based on the results from the product history record, the products met release criteria.Investigation has been completed based on current information.No further action is warranted at this time.The manufacturer internal reference number is:(b)(4).
Additional Manufacturer Narrative
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: 19341625
• Report Number: 9612169-2024-00463
• Device Sequence Number: 7130875
• Product Code: MJP
• UDI-Device Identifier: 00380652455152
• UDI-Public: (01)00380652455152(17)250313(11)211020(10)25281843(21)25281843047
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/19/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2025
• Device Model Number: CCWET3
• Device Catalogue Number: CCWET3.135
• Device Lot Number: 25281843
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2024
• Supplement Date Received by Manufacturer: 05/22/2024; 07/17/2024; 07/17/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 06/19/2024; 08/15/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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: ARTIFICIAL TEARS.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male