MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number TABLETOP

Device Problems Failure to Cut (2587); Gas/Air Leak (2946)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/21/2022

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

Event Description

A physician reported that an ophthalmic console exhibited vitrectomy cutting blade failed and the nitrogen pressure hose had multiple micro-perforations and leaking gas.There was no warning about losing pressure by the console.Patient was physically harmed due to vitrectomy blade failure.

Manufacturer Narrative

Following the submission of the initial report, it was discovered that a duplicate medical device report with manufacturer report number 2028159-2022-00855 was submitted relating to this event.As further information pertaining to the event and investigation is received this report with manufacture report number 2028159-2022-00855 will provide the additional information.The file related to manufacturer report number 2028159-2022-00920 will be closed.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14978088
• MDR Text Key: 296074600
• Report Number: 2028159-2022-00920
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657511501
• UDI-Public: 00380657511501
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K101285
• 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: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1