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

Catalog Number 8065921501

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

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.(b)(4).

Event Description

A health professional reported that an ophthalmic knife tip was crooked during a cataract surgery.The problem was not noticed before using the product.The procedure was completed on the same day.There was no harm to the patient.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report of the knife had a crooked tip during surgery therefore, the condition of the product could not be verified.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 photos provided by the customer were reviewed by the manufacturing site.The photos are of a tyvek label, the reported product and lot information is confirmed.A sample was not received at the manufacturing site and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable 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: 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: 11034418
• MDR Text Key: 241258493
• Report Number: 2523835-2020-00334
• 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: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065921501
• Device Lot Number: 322415M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1