MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CNWET0
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Intraocular Pressure Increased (1937)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported during surgery patient experienced hemorrhaging in the right eye, an elevation in intraocular pressure and the intraocular lens (iol) not to stay in alignment.Additional information has been received as there was bleeding in the eye during surgery, they could not get lens in straight, he had high eye pressure.He had additional surgery where they repositioned the lens.The patient had been taking blood thinner prior to surgery.No further information is available at this time.

• Brand Name: CLAREON VIVITY EXTENDED VISION HYDROPHOBIC 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: 15713211
• Report Number: 9612169-2022-00567
• Device Sequence Number: 20033943
• Product Code: POE
• UDI-Device Identifier: 00380652405041
• UDI-Public: 00380652405041
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: CNWET0
• Device Catalogue Number: CNWET0.100
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown