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

Model Number ASKU

Device Problems Mechanics Altered (2984); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2019

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.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during an intraocular lens (iol) implant procedure, the plunger of an injector overrode the lens.The physician did not feel comfortable implanting the lens due to it being possibly scratched.The procedure was completed the same day with no patient harm.

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

Manufacturer Narrative

An opened handpiece was returned for evaluation for the report of issue with plunger overrode lens.A review of the device history records traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.The handpiece was visually inspected and deemed nonconforming.The plunger head is slightly bent upward.A functional thread to barrel engagement check was performed and deemed conforming.A dimensional plunger position height check was performed and deemed nonconforming.The complaint evaluation confirms the injector plunger has a bend at the plunger head resulting in a slightly high plunger position.How and when the plunger position became damaged cannot be determined from this evaluation.The most likely root cause for the nonconforming plunger height is from poor handling.This injector has been in service for approximately nine years.All iol handpiece injectors are 100% inspected at the end of the manufacturing process to insure the correct plunger height is present before release of the product.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED
• 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: 9445020
• MDR Text Key: 183297875
• Report Number: 2523835-2019-00525
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: 818598M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TFAT00 17.0 AS UVA PANOPTIX; UNSPECIFIED VISCOELASTIC PRODUCT
• Patient Age: 63 YR