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

Catalog Number 8065752451

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

Patient Problem Retinal Injury (2048)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

This report originally filed as 1882955 the manufacturer internal reference number is: (b)(4).

Event Description

A physician reported a fresh retinal foramen was found during a final denting during a procedure.The foramina were treated with laser the eye was supplied with gas and patient had to camp.No hospitalization was required.The postoperative course was uncomplicated.

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14022498
• MDR Text Key: 288678664
• Report Number: 1644019-2022-00255
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524518
• UDI-Public: 00380657524518
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 8065752451
• Device Lot Number: 2373981H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK; CUSTOM-PAK SURGICAL PROCEDURE PACK; CUSTOM-PAK SURGICAL PROCEDURE PACK; UNSPECIFIED CUSTOM PAK, BEL
• Patient Outcome(s): Required Intervention
• Patient Sex: Male