MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE MONARCH III IOL DELIVERY SYSTEM, INJECTOR; LENS, GUIDE, INTRAOCULAR

Model Number III

Device Problems Device Damaged by Another Device (2915); Material Twisted/Bent (2981)

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

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

The product was 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 lot number was not provided.The manufacturer internal reference number is: (b)(4).

Event Description

A purchasing agent reported that during implantation of an intraocular lens (iol) the lens came out weird in eye and was scratched in injector.Additional information was received reporting inserter bent caused lens to twist and scratch.Lens removed immediately replaced by a backup lens.

Manufacturer Narrative

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

Manufacturer Narrative

One opened company injector was returned for evaluation for the report of the lens came out weird in the eye and was scratched, the injector was also bent.A visual inspection of the iol company injector was performed and was found to be nonconforming.The plunger is bent downward at the plunger head.A functional thread to barrel engagement check was performed and was found to be conforming.Finally, a dimensional plunger position height check 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 product was processed and released according to the product¿s acceptance criteria.The evaluation does confirm the injector plunger has a bent plunger head resulting in a downward plunger position.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 5 years.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• MDR Report Key: 12017525
• MDR Text Key: 256747133
• Report Number: 2523835-2021-00210
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380659777738
• UDI-Public: 00380659777738
• Combination Product (y/n): N
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: III
• Device Catalogue Number: 8065977773
• Device Lot Number: 169056M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACRYSOF TORIC IOL; MONARCH III D CARTRIDGE; PROVISC; ACRYSOF TORIC IOL; MONARCH III D CARTRIDGE; PROVISC
• Patient Age: 68 YR