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 Material Twisted/Bent (2981)

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

Event Date 11/07/2023

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 healthcare professional reported with a description of inserter pleated.Additional information has been requested, received and stated the event occurred prior to surgery with no patient contact.The operation has been completed using the backup.

Manufacturer Narrative

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

Manufacturer Narrative

One company model handpiece was returned for evaluation for the report of the injector pleated.A visual inspection of the intraocular lens (iol) handpiece injector was performed and was found to be nonconforming.The plunger was bent.A functional thread to barrel engagement check was performed and found to be conforming.Finally, a dimensional inspection for plunger position height was performed and was found nonconforming.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The evaluation does confirm the injector plunger has a bent plunger head resulting in a upward plunger position, which could result in the injector pleated.The root cause for the nonconforming plunger height is unknown.How and when how the plunger position became damaged cannot be determined from this evaluation.The most likely cause of a bent plunger head of the injector is from improper handling of the product.This injector has been in service for approximately 9 mos.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: 18281682
• MDR Text Key: 329901167
• Report Number: 2523835-2023-00686
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K212039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2024

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: 14LMDA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 01/03/2024; 02/17/2024
• Supplement Dates FDA Received: 01/25/2024; 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1