MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNWET3
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Malfunction
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following the cataract surgery with intraocular lens (iol) implant procedure, the patient reported that, can't even see computer screen and it is 26' away.Close vision i only had to use 1.25 readers.Close up vision is the same if not slightly worse.Additional information received and stated that, the patient¿s close vision and mid vision are now worse after implantation in eye.The patient feels like may have messed eyes up.The physician said that the lens in eye have shifted back slightly making it a plus instead of a minus and that a minus is needed for close vision.The physician suggestion was to wear readers 2.25 for computer work and 3.00 for reading or i could have lasik to fix it.That doesn't seem right.The vision for close up was blurry eye immediately after surgery.When the patient asked physician after the first follow up, physician said it was normal and takes time to focus.The patient was very upset that the doctor told lens didn't work on patient eye.The patient said vision is worse than ever.There are two medical device reports associated with this patient.This report is associated with the 1 of 2.

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18408744
• Report Number: 1119421-2023-02238
• Device Sequence Number: 2673732
• Product Code: MJP
• UDI-Device Identifier: 00380652466394
• UDI-Public: 00380652466394
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/28/2023

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 Model Number: CNWET3
• Device Catalogue Number: CNWET3.180
• Device Lot Number: 15521007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• 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