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

Catalog Number 9215010002

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 11/25/2020

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.(b)(4).

Event Description

A customer reported observing jagged tip on a knife.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report of the knife had a jagged tip; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).

• Brand Name: A-OK OPHTHALMIC 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: 11001972
• MDR Text Key: 222008260
• Report Number: 2523835-2020-00325
• 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: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9215010002
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2021
• Patient Sequence Number: 1