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

Catalog Number 8065751617

Device Problem Decrease in Suction (1146)

Patient Problems Corneal Abrasion (1789); Corneal Edema (1791); Corneal Ulcer (1796); Retinal Detachment (2047); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/10/2022

Event Type  Injury  

Event Description

A physician reported that the cutting aspect was of the vitrectomy cutter was present, but the aspiration was weak during a combined cataract vitrectomy procedure.This was the second cutter used post failure of the first cutter due to no cutting (reported in a separate file).The physician determined to continue to use this probe (despite the low aspiration and the forty-40-minute delay).It was then, that the physician increased the vacuum to 600.However, the epiretinal membrane peel (emp) was almost impossible to attempt and the case was then aborted.This resulted in postoperative corneal abscess, corneal edema, retinal detachment, sequelae of incomplete macular peeling and epithelial degradation.During the next surgical day for observation, there were several surgical variables that contributed to the reported events.The patient was hospitalized because he was demented and it was impossible to administer the treatment of corneal edema induced by the various pre-operative inconveniences.This is two of two reports.

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).

Manufacturer Narrative

One opened probe was received, without tip protector, in a tray along with other item.At the time of receipt, was noted that the tubing was cut off.The sample was visually inspected and found to be conforming.The sample was then functionally tested for actuation and aspiration.The sample was found to be conforming for both functional test.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.The returned sample was found to be conforming, therefore an aspiration failure as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the returned probe was manufactured to specifications.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.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).

• 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: 13313330
• MDR Text Key: 284168571
• Report Number: 1644019-2022-00071
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657516179
• UDI-Public: 00380657516179
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 8065751617
• Device Lot Number: 2505106H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK.; CONSTELLATION VISION SYSTEM.; CONSTELLATION VISION SYSTEM.
• Patient Outcome(s): Other
• Patient Age: 85 YR
• Patient Sex: Male