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

Catalog Number 8065751900

Device Problem Material Disintegration (1177)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/05/2016

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

A customer reported that a small piece of debris was seen in the back of the eye during a pars plana vitrectomy.The reporter informed that "there was nothing else other than basic salt solution injected into the eye during the case." additional information has been requested for this case.No updates have been received at this time.

Manufacturer Narrative

No sample has been returned for evaluation for the report of debris in eye; 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 root cause for the defect experienced by the customer cannot be determined.(b)(4).

Event Description

A customer reported that a small piece of debris was seen in the back of the eye during a pars plana vitrectomy.The reporter informed that "there was nothing else other than basic salt solution injected into the eye during the case".Additional information has been requested for this case.No updates have been received at this time.

• 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: 6187661
• MDR Text Key: 63189176
• Report Number: 1644019-2016-01552
• 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: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 8065751900
• Device Lot Number: 1875901H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2016
• 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: BASIC SALT SOLUTION; TROCAR VALVE
• Patient Outcome(s): Other