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

Model Number TABLETOP

Device Problem Component Missing (2306)

Patient Problem No Code Available (3191)

Event Date 10/24/2019

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.(b)(4).

Event Description

A customer reported that there was no laser during a vitreoretinal procedure.The facility was not sure if this was a laser probe or a system issue.The surgeon opted to complete the surgery using a gas injection in the eye.It was noted at the postoperative visit that the gas reabsorbed and another gas injection was required.It was again verified at later postoperative visit that the gas had reabsorbed again.The patient returned to the operating room for laser application on (b)(6) 2019.Additional information has been requested.

Manufacturer Narrative

Corrected information has been provided in b.5, e.1 and e.3.Additional information has been provided in g.1, g.2, h.6 and h.10.The company service representative examined the system and noted system message (sm) [laser controller power monitor post error laser functions will be disabled.] that was related to the reported issue.The company service representative communicated to the customer that the laser module be replaced to resolve the issue.The customer did not approve of the service quote and therefore no further servicing was performed.Based on assessment, the product met specifications at the time of release.The customer did not return the laser probe for evaluation.The lot number (l/n) was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.With no additional, related information provided, the customer reported event could not be confirmed.The manufacturer internal reference number is: (b)(4).

Event Description

The patient agreed to return to the operating room for laser application on (b)(6) 2019.

• 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: 9387187
• MDR Text Key: 168439085
• Report Number: 2028159-2019-02135
• 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: 02/26/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 01/27/2020
• Supplement Dates FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LASER PROBE
• Patient Outcome(s): Required Intervention