MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; FOLDERS AND INJECTORS , INRAOCULAR LENS (IOL)

Model Number IV

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2023

Event Type  malfunction  

Manufacturer Narrative

A sample device was returned for analysis.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).

Event Description

A facility reported during an intraocular lens (iol) implant procedure, the plunger missed tip of lens and there was no patient contact with the product.Additional information was requested.

• Brand Name: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR
• Type of Device: FOLDERS AND INJECTORS , INRAOCULAR LENS (IOL)
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16799729
• MDR Text Key: 313865913
• Report Number: 2523835-2023-00181
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777745
• UDI-Public: 00380659777745
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/24/2023

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
• Device Operator: Health Professional
• Device Model Number: IV
• Device Catalogue Number: 8065977774
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; OCUCOAT
• Patient Sex: Female