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

Model Number TABLETOP

Device Problems Device Emits Odor (1425); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2021

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 customer reported that during a retinal detachment repair of the right eye, the ophthalmic operating console footswitch would not engage and a message appeared on the screen.The console presented with a smell that seemed like an ¿ozone¿ smell and not an electrical smell.The surgeon was able to complete the vitrectomy portion of the procedure but was unable to initiate the laser portion.The facility did not have a back-up console to complete the procedure, so the eye was stabilized by injecting silicon oil and the patient was scheduled for a second procedure on the following day.The patient returned to the operating room the next day where the procedure was completed.Additional information was requested and received, the customer has no further details to provide at this time.

Manufacturer Narrative

The company service representative, examined the system.And replicated the reported event of system message and footswitch issue.System message (sm) [laser controller 12 volt power error.Laser functions will be disabled] displayed on the system.The footswitch was replaced to resolve the issues.Unrelated to the reported event, the interface breakout printed circuit board (pcb) that was damaged, due to the footswitch, as well as the illuminator module.The company service representative, did not replicate the reported event of the ozone odor.The system was then tested.And met all product specifications.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 can be attributed to a nonconforming footswitch.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

No sample evaluation required as sample received was unrelated to the reported event.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 ; 8175514979
• MDR Report Key: 11986275
• MDR Text Key: 255925728
• Report Number: 2028159-2021-00624
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657511501
• UDI-Public: 00380657511501
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention