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

Model Number TABLETOP-JAPAN

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Hemorrhage/Bleeding (1888); Vitreous Hemorrhage (2143)

Event Date 06/17/2021

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 physician reported that an ophthalmic operating console's screen background turned blue and the screen was filled with english writing (instead of japanese writing) during a vitrectomy procedure.The patient experienced a vitreous hemorrhage as the surgery took longer than usual for completion.The patient would be under follow-up observation.Additional information received indicated that the patient experienced choroid bleeding.The patient is recovering and did not require further treatment.

Manufacturer Narrative

The company representative provided phone support to the customer.The company representative assisted the customer in restarting the system to resolve the issue.The customer was notified to contact again if the issue reoccurs.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event cannot be determined conclusively.Data will continue to be monitored for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information is provided in sections h.3, h.6 and h.10.A service request (sr) was subsequently opened for preventative maintenance (pm).The host module was replaced to address the issue.The system was then tested and met all product specifications.A host module was received, and a visual assessment of the returned sample revealed no obvious nonconformity.The returned host module was installed into the system and tested.The reported event was not replicated.There were no issues observed and the japanese language could be selected through user settings.No other functional issues were observed.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 ; 8007579780
• MDR Report Key: 12167941
• MDR Text Key: 261533229
• Report Number: 2028159-2021-00742
• 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,Followup
• Report Date: 12/27/2021

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: 09/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 09/07/2021; 12/01/2021
• Supplement Dates FDA Received: 10/06/2021; 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR