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 05/31/2022

Event Type  malfunction  

Manufacturer Narrative

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 representative reported that during an intraocular lens (iol) implant procedure, the iol would not advance out of cartridge.There was no patient contact was reported.Additional information has been received and stated that, the problem was loading error.The problem was identified during loading/priming/preloading with no patient contact.A replacement lens was used to completed procedure the same day.In the surgeon¿s opinion, the quality of the iol did not cause or contributed to the event.

Manufacturer Narrative

On initial mdr the h8 ¿initial use¿ was submitted in error, it should have been ¿reuse of reusable device¿ in the original mdr.A handpiece sample was not received at the manufacturing site for evaluation for the report of would not advance out of cartridge; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The root cause for the customer complaint issue cannot be determined.The manufacturer internal reference number is: (b)(4).

• 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: 15026020
• MDR Text Key: 297178612
• Report Number: 2523835-2022-00257
• Device Sequence Number: 1
• Product Code: MSS
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

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
• Device Model Number: IV
• Device Catalogue Number: 8065977774
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/06/2022
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/15/2022
• Supplement Dates Manufacturer Received: 09/14/2022
• Supplement Dates FDA Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON ASPHERIC UV ABSORBING IOL; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D