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

Model Number ASKU

Device Problem Environmental Compatibility Problem (2929)

Patient Problem Retinal Injury (2048)

Event Date 02/27/2020

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.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that during a vitrectomy procedure for the repair of a retinal detachment on a male patient in his sixties, the illumination from the system in both ports one and two were dim.The brightness was barely enough to complete the procedure.There was no harm to the patient.It was noted by the staff on the following day that the system had four ports for illumination and ports three and four were not tried as they did not realize they were for the illumination.Additional information was requested and received.

Manufacturer Narrative

Additional information has been provided in h.6.And h.10.No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is:(b)(4).

Manufacturer Narrative

Supplemental medical device report (smdr) # 01 is being filed to correct the g.4 date on the prior filed supplemental report.Incorrect date of 03/02/2020 is being corrected to 02/28/2020.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: 9877871
• MDR Text Key: 186830837
• Report Number: 2028159-2020-00276
• 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,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 03/25/2020; 05/28/2020
• Supplement Dates FDA Received: 03/27/2020; 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 25G CHANDELIER ENDOILLUMINATOR