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

Model Number TABLETOP

Device Problem Inadequate Lighting (2957)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2017

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 available.(b)(4).

Event Description

A customer reported that the table top illuminator was noticed to be out during a vitrectomy procedure.The staff switched to another light source and increased the light to complete the procedure.There was no patient harm.

Manufacturer Narrative

The company service representative examined the system and found system message (sm) - ¿lamp calibration data is corrupted: lamp needs to be calibrated.Please contact field service¿ displayed in the event log.The company service representative restarted the system and the sm did not display.However, the company service representative replaced the illuminator module as a preventative measure.The system was then tested and met all product specifications.The system was manufactured on november 23, 2009.Based on qa assessment, the product met specifications at the time of release.The illuminator module was received and a visual assessment of the returned sample revealed no obvious nonconformity.The sample was installed into a calibrated system for functional testing.Upon boot-up the system displayed sm ¿lamp calibration data is corrupted: lamp needs to be calibrated.Please contact field service¿; however, this sm is only an advisory and displays normally when a new illuminator is installed into the system and thus does not indicate an issue.The system was rebooted but the sm did not display again.The module was then tested and found to meet specifications.The root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7016503
• MDR Text Key: 92498799
• Report Number: 2028159-2017-04236
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• 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
• Other Device ID Number: 8065751150
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other