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

Model Number TABLETOP

Device Problem Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A customer reported that an ophthalmic console exhibited with excessive pressure.Additional information has been requested, but none received to date.

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

Corrected information is provided in sections b.2,b.,5.H.2., and h.11.Based on this information received following submission of the initial report, this event excess pressure does not meet criteria for reporting as a malfunction.No further report will be submitted under this mfg: 2028159-2022-00598 the manufacturer internal reference number is: (b)(4).

Event Description

The initial decision to report was incorrect resulting in the initial report being submitted in error.This event (excess pressure) is not considered to be a reportable malfunction, and it is not likely that a recurrence would result in serious injury.

• 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: 14306666
• MDR Text Key: 290928763
• Report Number: 2028159-2022-00598
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657511501
• UDI-Public: 00380657511501
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• 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
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1