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

Catalog Number 8065982465

Device Problem Break (1069)

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

Event Date 08/08/2018

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.Additional information has been requested.(b)(4).

Event Description

A physician reported that a knife exhibited a burr on the tip of the blade during surgery.Patient involvement and patient impact information is unknown.Additional information has been requested.

Manufacturer Narrative

Additional information is provided.No sample has been returned for evaluation for the reported issue of a burr on the tip of the blade 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 photo attached to the parent complaint was reviewed by the manufacturing site.The photo is of a partial lidstock by which the reported lot number and product number were confirmed.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).

• Brand Name: CLEARCUT KNIVES
• Type of Device: KNIFE, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• MDR Report Key: 7801151
• MDR Text Key: 117854010
• Report Number: 2523835-2018-00392
• 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: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 8065982465
• Device Lot Number: 242432M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other