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

Catalog Number 9215320001

Device Problem Bent (1059)

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

Event Type  malfunction  

Manufacturer Narrative

No sample has been received by manufacturing for evaluation.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.This is the first of two reports from this facility.(b)(4).

Event Description

A nurse reported that multiple knife blades were bent or barbed.Procedure details, patient involvement and patient impact information is unknown.

Manufacturer Narrative

Additional information is provided.No sample has been returned for evaluation for the report of blades being bent or barbed therefore, the condition of the product could not be verified.A review of the device history record related to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates that there are no additional complaints associated with the lot for the reported issue.A sample was not returned and the device history record review of the lot number provided indicates that the product was processed and released according to acceptance criteria 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).

Event Description

Additional information received clarified that the unsatisfactory knives were noted prior to surgery during set up when the knives were viewed under the microscope.There was no patient contact therefore, no impact to any patient.

• Brand Name: I-KNIFE
• 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7320773
• MDR Text Key: 101980876
• Report Number: 2523835-2018-00108
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 9215320001
• Device Lot Number: 219347M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other