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

Catalog Number 8065992445

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

A sample has been received and in-house testing is in progress.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 the manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that while making the initial incision for a cataract extraction with intraocular lens implant procedure it was noted that the score line of the blade was on the bottom instead of the top.The case was completed using an alternate knife.There was no harm to the patient.

Manufacturer Narrative

One opened knife was received seated correctly in a tray, with no knicks found on the tray, for the report of bevel issue.The returned sample was visually inspected and was found to be nonconforming with the bevel in the incorrect orientation.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.When assembled using the automated assembly method, knives are first assembled in a straight form and then bent to the desired angle and direction of the bevel.During this process it is possible for the blade to be placed into the assembly fixture backwards and then assembled with the bevel facing in the wrong direction.When the knife is then angled, the bevel is then in the wrong location.There are two automated machines that manufacture this product; one has an inspection for bevel orientation and the other does not.This complaint does not have a reported lot number, therefore, it cannot be confirmed which machine the returned product was manufactured on.(b)(4).

• Brand Name: CLEARCUT INTREPID KNIVES
• Type of Device: KNIFE, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6401964
• MDR Text Key: 70100033
• Report Number: 2523835-2017-00176
• Device Sequence Number: 1
• Product Code: HNN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065992445
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other