MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE CLEARCUT KNIVES; KNIFE, OPHTHALMIC

Catalog Number 8065982265

Device Problems Difficult to Remove (1528); Dull, Blunt (2407)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2018

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.Based on the preliminary investigation findings, there has been no change in the criticality for this complaint.(b)(4).

Event Description

A physician reported that knives were noted to be difficult to remove from the package, were bent and dull prior to the start of cataract surgery.There was no patient involvement therefore, no patient impact.

Manufacturer Narrative

No knife sample has been returned for evaluation for the report of being dull, bent, and difficultly with opening product therefore, the condition of the product could not be verified.No lot number was identified with this complaint therefore, lot history and complaint history reviews could not be conducted.The three photos show the complaint knife in a blister, in the protective tray and then lying on the prep area.The reported product was confirmed from the photos.A yellow handled knife in the photos does not pertain to this file.A sample was not returned and no lot information is available therefore, the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown therefore, specific action with regards to this complaint cannot be taken.All knives are 100% inspected by trained operators using a minimum of 10x magnification during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLEARCUT KNIVES
• Type of Device: KNIFE, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• MDR Report Key: 8191672
• MDR Text Key: 131333389
• Report Number: 2523835-2018-00530
• Device Sequence Number: 1
• Product Code: HNN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065982265
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1