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 Device Damaged by Another Device (2915)

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

Event Date 09/05/2023

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: 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)(6).

Event Description

A physician reported that during the implantation of lens it was observed that there was mark or crack or fissure on optic of lens when observed through the microscope.Additional information has been received that there was no patient harm.Additional information has been received that the reporter suspect that the injectors are the ones that have presented defects since the lenses are verified before assembly under a microscope and at that time no damage has been observed in the lens until after that the injector has been used for implantation.There are three medical device reports associated with this file.This report is associated with the 3 of 3 files.

Manufacturer Narrative

One opened company injector was received for the report of mark, fissure on optic of lens after implantation.The returned sample was visually inspected and found to be conforming.A dimensional test was performed for plunger height position and deemed conforming.A functional test was performed for thread engagement and plunger movement through the barrel and deemed conforming.Two photos attached to the parent complaint were reviewed by the investigation site.The photos show the lens with scratch/mark, confirming the reported issue.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 returned sample was found to be conforming for all visual inspections, dimensional inspections and functional tests, associated with the reported event, therefore the mark, fissure on optic of lens after implantation as described in the complaint caused by the injector was not confirmed and a root cause cannot be determined for the complaint as described by the customer.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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: 18424295
• MDR Text Key: 331923091
• Report Number: 2523835-2024-00007
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777745
• UDI-Public: 00380659777745
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K212039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2024

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: 14V9L8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 01/17/2024; 03/18/2024
• Supplement Dates FDA Received: 02/12/2024; 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL; CONSTELLATION HANDPIECE; DUOVISC; MONARCH III CARTRIDGE D