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

Model Number CNW0T4

Device Problems Defective Component (2292); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

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 Description

A hcp reported that following an intraocular lens (iol) implant procedure, the patient had uncorrected vision was 20/40 with refraction -1.00+1.50x25 is 20/25.Additional information received from the surgeon and stated that, surgeon did not thought it is an unexpected outcome , however iol needs to be rotated.Additional information has been requested.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received from the surgeon and stated that, surgeon replied stating they went back to operation room to rotate lens, but was not successful due to one of the haptics was very adherent to the capsular bag.

Manufacturer Narrative

Additional information provided in h.3., h.6., and h.10.The product investigation could not identify a root cause for the reported complaint.The product remains in the patient's eye.No further information has been provided at this time.The file will be reopened when new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC IOL
• Type of Device: 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: 16580613
• MDR Text Key: 311659985
• Report Number: 1119421-2023-00500
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 00380652410175
• UDI-Public: 00380652410175
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNW0T4
• Device Lot Number: 15412927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR