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 11/02/2023

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 that during an intraocular lens (iol) implant procedure, while implanting the lens the posterior haptic is impacted in the head of the plunger.When retracting it there was de-insertion of the haptic.The surgeon cut the lens and replaced with another lens during the initial procedure.Lens was managed to change without damage to capsular bag.Additional information has been requested.

Event Description

Additional information has been received that the symptoms has resolved.

Manufacturer Narrative

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

Manufacturer Narrative

One opened blue handpiece injector was returned for evaluation for the report of the posterior haptic impacted in the head of plunger, in and out.A visual inspection of the injector was performed and was found to be conforming.A dimensional inspection for plunger position height was performed and was found to be conforming.Also, a functional thread to barrel engagement check was performed and was found to be conforming.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 show suspect device, unable to confirm the reported event.The returned sample was found to be conforming for all visual, functional and dimensional testing associated with the reported event, therefore an injector with posterior haptic impacted in the head of plunger, in and out, as described in the complaint 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).

• 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: 18204381
• MDR Text Key: 328900530
• Report Number: 2523835-2023-00649
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2024

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: 11/03/2023
• Initial Date FDA Received: 11/24/2023
• Supplement Dates Manufacturer Received: 11/27/2023; 02/05/2024
• Supplement Dates FDA Received: 12/22/2023; 03/04/2024
• 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: CARTRIDGE D.; DUOVISC.; VIVITY EXTENDED VISION HYDROPHOBIC IOL.
• Patient Age: 69 YR
• Patient Sex: Female