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

Catalog Number 8065751901

Device Problem Fluid/Blood Leak (1250)

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

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

An ophthalmic surgeon reported that the first valved trocar cannula leaked upon initial insertion and the patient's eye collapsed.The surgeon inserted the infusion line into the trocar and the surgeon was able to pressurize the eye.The second and third valved trocar cannulas were observed leaking to the extent where there surgeon was unable to get the third cannula into the eye due to the eye being soft.Over time the leaking appeared to subside and the procedure was completed.There were no consequences to the patient.Additional information has been requested.The product sample is not available for evaluation.

Manufacturer Narrative

A review of the device history record indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there are four additional complaints associated with the lot for the reported issue.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.No sample was returned and the device history record review of the lot number provided indicated product was processed and released according to the product¿s acceptance criteria; therefore, the root cause for the defect experienced by the customer cannot be determined.Investigations have been initiated in order to improve the performance of the valves.Complaints are reviewed and monitored at regular intervals to evaluate effectiveness of actions taken.No additional action is required at this time.(b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6198634
• MDR Text Key: 63519505
• Report Number: 1644019-2016-01563
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 8065751901
• Device Lot Number: 1920773H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other