MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CENTURION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065752200

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Eye Burn (2523); Device Embedded In Tissue or Plaque (3165)

Event Date 01/31/2020

Event Type  Injury  

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.The manufacturer internal reference number is: (b)(4).

Event Description

A pharmacist reported a patient experienced a corneal burn at incision edge during cataract extraction surgery.The phacoemulsification (phaco) did not work with the handpiece.The handpiece made "milk" in the patient's lens.The handpiece was removed form the eye and exchanged but the system did not work well.The system was switched to perform a combined vitrectomy/ cataract procedure due to a burned cornea and a dislocated fragment that fell into the vitreous cavity.There was corneal melting at closure of the case.The patient was hospitalized.Additional information has been requested but not received.This is one of four reports from this facility.

Manufacturer Narrative

The returned sample was visually and functionally evaluated on a calibrated console.Inspection of the sample found no obvious defects that would have contributed to the reported event.The fluidics management system (fms cassette) was tested on a calibrated console and the fms primed and tuned with the ultrasonic hand piece successfully and could achieve maximum vacuum.No system message was generated during functional testing.No fluid or air leaks, and no cracks were observed from the connectors.The irrigation and aspiration flow rates were measured and found to be within specifications.Fluid flowed from the bss bottle through the irrigation path continuously, no fluidic anomalies were observed.No occlusion or obstruction was identified during inspection and functional testing.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 root cause of the customer's complaint could not be established as the returned fms cassette was evaluated and met specifications.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 9819362
• MDR Text Key: 183075005
• Report Number: 1644019-2020-00137
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 8065752200
• Device Lot Number: 2339243H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION FOOTSWITCH; CENTURION VISION SYSTEM; CONSTELLATION VISION SYSTEM; OZIL TORSIONAL PHACO HANDPIECE; POUCH OF BSS 500 ML, LOT 303418F
• Patient Outcome(s): Hospitalization; Required Intervention