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

Catalog Number	8065752059
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Retinal Injury (2048)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported while indenting the globe a fresh retinal foramen was found.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.Additional information received from the company representative indicating during the surgery all the 27g and 25g trocars were spontaneously leaking immediately after insertion leaked out of the valves.This report is for 27g trocar.
Additional 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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation; 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 reported product was processed and released according to the reported product¿s acceptance criteria.A sample was not received at the manufacturing site and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the customer complaint issue cannot be determined.Investigations have been completed and manufacturing process enhancements have been implemented in order to improve the performance of the valves.Complaints are reviewed and monitored at regular intervals to evaluate effectiveness of actions taken.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Upon further review of the reported description, it was determined that a fresh retinal foramen was found in direct projection onto the cannula of health care professional (hcp¿s) right hand during a final denting during a procedure.An additional intervention of laser was performed to treat the retinal foramen.The foramina were entry side breaks (esbs).During the surgery all the 27g and 25g trocars were spontaneously leaking (leaked out of the valves) immediately after insertion.There were multiple products reported from the site as potentially involved the reporter could not provide clarification regarding which product is associated with this complaint.This report represents the pack with a 27 gauge valved trocars.

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Common Device Name: 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: 14014287
• Report Number: 1644019-2022-00245
• Device Sequence Number: 11919499
• Product Code: LRO
• UDI-Device Identifier: 00380657520596
• UDI-Public: 00380657520596
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 8065752059
• Device Lot Number: 2290944H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION SURGICAL PROCEDURE PAK.; UNSPECIFIED CUSTOM PAK, BEL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female