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

Catalog Number 8065992745

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

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.All knives are 100% inspected by trained operators using a minimum of 10x magnification during manufacturing.  any defects, such as damaged tips and cutting edges, are removed from the lot and scrapped.Sharpness testing is performed and monitored during the finishing process to ensure the sharpness of the product.(b)(4).

Event Description

A nurse reported that glistening was noted at the wound opening.There was no patient harm.Additional information received indicated this occurred with two knives one for the main port and one for the side port.The surgeon did try to remove the glistening from both ports but was unsuccessful.The glistening still remains in the patient's eye.No additional treatment was administered for this event.This report represents the knife used for the main port incision and is one of two reports from this facility.

Manufacturer Narrative

One opened angled slit knife was received in blister with the foam tip protector for the report of glistening at the wound opening.The tip of the blade was sticking out of the foam.The returned sample was visually inspected and was found to be conforming.The foam tip protector and the blister were also visually inspected for metal particulate; no metal particles were found in or on the foam tip protector and blister.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 returned opened samples were found to be visually conforming, therefore metal particles as described in the complaint were 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: 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: 9546063
• MDR Text Key: 178330542
• Report Number: 2523835-2020-00002
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065992745
• Device Lot Number: 299824M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLEARCUT SIDEPORT FULL HANDLE