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

Catalog Number 8065751058

Device Problem Sticking (1597)

Patient Problem Retinal Tear (2050)

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 customer reported that a vitreous hemorrhage occurred when the vitreous probe became stuck in the port.To resolve the issue the surgeon removed the entire port along with the vitreous probe; which resulted in vitreous egress and slight retinal tear.The product was replaced and then patient was treated with the laser and cryo.Additional information and product sample have been requested for evaluation.

Manufacturer Narrative

No probe sample was returned for evaluation; therefore, the condition of the product could not be verified.A review of the related device history records for the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.Additionally, no trocar sample was returned for evaluation; therefore, the condition of the product could not be verified.A review of the related device history records for the reported lot number, indicates that the product was processed and released according to the product's acceptance criteria because a sample of the probe and the trocar was not returned by the customer; the root cause for customer's reported issue cannot be determined.(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: 5993399
• MDR Text Key: 56182154
• Report Number: 1644019-2016-01275
• 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,other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 8065751058
• Device Lot Number: 1876730H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2016
• 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
• Treatment: PORT TROCAR; PROBE
• Patient Outcome(s): Other; Required Intervention