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

Model Number TABLETOP-JAPAN

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 01/30/2019

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 surgeon reported that he was performing a combination cataract/vitrectomy procedure.The cataract procedure was performed by a non-company system and then the vitrectomy was to be performed using our system.Three ports were made however the light guide did not work.The surgeon attempted to perform vitreous surgery under microscope as possible as he can, however, the surgeon was not able to have proper operative field so that he decided it was difficult to remove safely submacular hematoma.Vitreous humour and bleeding in vitreous humour were removed and aspirated as much as possible and the surgery was not completed as scheduled.Re-operation was performed the following day.

Manufacturer Narrative

The company service representative (ar) examined the system and replicated the reported event.The xenon lamp and the electrode tube were replaced to resolve the issue.The system was then tested and met all product specifications.The xenon lamp and the electrode tube were received and both samples did not show any obvious visual non-conformities.The lamp was installed in a calibrated vision system and tested.The sm [the lamp in the table top illuminator needs to be replaced.Please contact field service] displayed and an arcing sound was heard when the lamp was turned on.The reported event was replicated.The lamp was taken out of the system and inspected.One of the banana plugs was found to have a crimped connector resulting in an intermittent contact with the module electrodes.The tube electrodes were found to have no problem.The reported issue was caused due to the lamp having an intermittent ignition issue.The system was manufactured on june 6, 2013.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to a non-conforming lamp.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
• MDR Report Key: 8379795
• MDR Text Key: 137507496
• Report Number: 2028159-2019-00310
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TABLETOP-JAPAN
• Device Catalogue Number: 8065751817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR