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 Insufficient Information (4580)

Event Date 10/03/2023

Event Type  malfunction  

Manufacturer Narrative

A sample device was not 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 pharmacist reported that during an intraocular lens (iol) implant procedure, they observed a microcrack in the peripheral optics of the lens.Additional information has been received, indicating that the injectors were the components that exhibited defects.The lenses were verified before assembly under a microscope, and at that point, no damage was observed in the lens.However, it was noted that damage occurs only after the injector has been used for implantation.

Manufacturer Narrative

One company handpiece injector was returned for evaluation for the report of a microcrack in the peripheral optics, in/out.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.The evaluation does confirm the injector plunger has a bent plunger head resulting in a upward plunger position, which could result in a microcrack in the peripheral optics.The root cause for the nonconforming plunger height is the bent plunger.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: 18423203
• MDR Text Key: 331906377
• Report Number: 2523835-2024-00005
• 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
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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: 14V9L7
• 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: 01/01/2024
• Supplement Dates Manufacturer Received: 03/31/2024
• Supplement Dates FDA Received: 04/26/2024
• 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 TORIC EXTENDEDVISION HYDROPHOBICIOL; DUOVISC VISCOELASTIC SYSTEM; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Patient Age: 51 YR
• Patient Sex: Male