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

Model Number TABLETOP-JAPAN

Device Problem No Pressure (2994)

Patient Problem Intraocular Pressure Decreased (4468)

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

A sample is available that has not yet been received at manufacturing for evaluation.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 that during surgery the intraocular pressure (iop) was unavailable on the console at the time of gas replacement.The surgery was completed after console iop was turned off.There was no harm to the patient.

Manufacturer Narrative

Additional information has been provided in section d.9, h.3, h.6 and h.10.The company representative confirmed and replicated the reported event.The fluidics was replaced to resolve the issue and was returned for evaluation.The system was tested and found to meet product specifications.The fluidics was received for evaluation.A visual assessment of the returned sample revealed no obvious non-conformity.The returned part was installed into a system and tested.The reported event was not replicated.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.The manufacturer 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 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 ; 8175514979
• MDR Report Key: 12513767
• MDR Text Key: 272728338
• Report Number: 2028159-2021-01079
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101285
• 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: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP-JAPAN
• Device Catalogue Number: 8065751817
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1