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

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 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 reported.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 2 of 3 files.

Manufacturer Narrative

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

Manufacturer Narrative

One company handpiece injector was returned for evaluation for the report of mark, fissure on optic of lens after implantation.A visual inspection of the iol handpiece injector was performed and was found to be nonconforming, with the plunger observed bent.A functional thread to barrel engagement check was performed and was found to be conforming.Finally, a dimensional inspection for plunger position height was performed and was found nonconforming due to the bent condition of the plunger.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.Photos attached to the parent file were reviewed by the manufacturing site.Photo 1 and 2 cannot confirm reported issue.The evaluation does confirm the injector plunger has a bent plunger head resulting in a upward plunger position, which could result in lens damaged.The root cause for the nonconforming plunger height is unknown.How and when how the plunger position became bent 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 21 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: 18417476
• MDR Text Key: 331598015
• Report Number: 2523835-2023-00753
• 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: 05/31/2024

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: 12/05/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 01/17/2024; Not provided
• Supplement Dates FDA Received: 02/12/2024; 05/31/2024
• 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 VISION SYSTEM, ACCESSORY, HANDPIECE.; DUOVISC VISCOELASTIC SYSTEM.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.