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

Catalog Number 8065000096

Device Problem Inability to Irrigate (1337)

Patient Problem Intraocular Pressure Decreased (4468)

Event Date 01/23/2023

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.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported irrigation failure.After cataract surgery was completed, the vitrectomy was cancelled because the intraocular pressure dropped and there was concern about infusion flow when the surgery was changed to vitrectomy.

Manufacturer Narrative

A review of the device history record traceable to the reported lot number indicated that the product was processed and released according to the product¿s acceptance criteria.A customer reported that infusion pressure did not increase during vitrectomy surgery.The returned sample was inspected, and a non-alcon red trocar was connected to the infusion cannula.These observations suggest the customer was attempting to use non-alcon product that did not originate from this procedure combined cassette pack.The root cause of the customer's complaint was user error.The customer did not adhere to the directions-for-use for this procedure pack.User error was the cause for this event and therefore no action will be taken for this occurrence.Current tracking indicated no adverse trend for this lot for this event.Quality assurance had reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PACK
• 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: 16367096
• MDR Text Key: 309435745
• Report Number: 1644019-2023-00153
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380650000965
• UDI-Public: 00380650000965
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 8065000096
• Device Lot Number: 14JC4R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM
• Patient Outcome(s): Required Intervention; Other