MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Catalog Number 8065751763

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/31/2018

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.(b)(4).

Event Description

A surgeon reported that a patient underwent a cataract extraction with intraocular lens implant (iol).At the one day postoperative visit the patient presented with fibrin precipitation.Additional information has been requested.

Manufacturer Narrative

A customer reported that several patients presented with fibrin in the anterior chamber following cataract surgery.The fibrin has been occurring since october 2017.The operating room was renovated from january 2018 to february 2018.Surgery was restarted in march 2018.The customer does not think the renovation contributed to the events, because fibrin was reported in october 2017.The customer noted that congestion and cell was not confirmed, and the fibrin was not due to bacteria.The fibrin precipitation was sterile.The customer is investigating the events to rule out the system, all related things such as the iol, other surgical tools, and sterilization methods.The sterilization method has not been changed.The customer does not believe the system settings contributed to the events.The customer is reviewing the fibrin precipitation with other products such as the capsel tension ring, which is currently being used.The medical treatment for the patients is unknown.The patient's symptoms improved within a few days.Additional information received noted the difference between these cases and the past cases, is the air conditioner was not being used during the morning.The customer suspects the cause of the event is likely due to the air conditioner.The customer is requesting an inspection by an expert to assess if there is floating matter and falling bacteria.The president of the clinic noted no causal relation between the events and any company product.Fibrin is a strong insoluble protein produced by our body in response to bleeding.Whenever a tissue damage results in bleeding, at the site of the wound, a soluble protein found in blood plasma called fibrinogen becomes converted into fibrin molecules by the action of a clotting enzyme called thrombin.Fibrin is a major component of a blood clot.It should be clear to our understanding that fibrin is made by the body only when it is needed.When someone sustains a wound, the body automatically releases thrombin, which then signals the liver to produce fibrinogen and the process initiates the production of fibrin.Fibrin helps create a barrier at the site of wound to stop further bleeding allowing the wound to heal.The phacoemulsification systems are closed systems.They are operated with a sterile single use consumable cassette which is designed to isolate the patient fluid path from the console itself.Any surgical instrumentation that would come into contact with the patient would be cleaned and autoclaved by the user prior to surgery, per standard industry practices and company directions for use (dfu).There is no evidence that the design or manufacturing of the system or phaco handpiece contributed to the reported event.The system was manufactured on june 28, 2017.Based on qa assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported event could not be confirmed.The root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7451630
• MDR Text Key: 106199552
• Report Number: 2028159-2018-00828
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• 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: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Other Device ID Number: 380657517633
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CAPSULE TENSION RING; CENT FMS PACK,ACT,0.9N TIPLESS; CAPSULE TENSION RING; CENT FMS PACK,ACT,0.9N TIPLESS
• Patient Outcome(s): Other