MAUDE Adverse Event Report: ALCON RESEARCH, LLC CLAREON MONARCH IV; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Corneal Abrasion (1789)

Event Type  malfunction  

Event Description

Scratch at 2 o'clock mid to peripheral optic as it was going into the eye.Fda safety report id #(b)(4).

• Brand Name: CLAREON MONARCH IV
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 15716175
• MDR Text Key: 302966534
• Report Number: MW5113038
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/31/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White