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

Model Number TABLETOP-JAPAN

Device Problem Insufficient Information (3190)

Patient Problems Cataract (1766); Eye Injury (1845); Collapse (2416)

Event Date 07/20/2018

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 surgeon reported during the second case, he reported the irrigation did not drip and the eye collapsed due to hypotony during a vitrectomy procedure.The trocar touched the crystalline lens in two spots and a cataract developed.The issue was resolved by the surgeon adding irrigation solution from a syringe into the 3 way stopcock and the procedure was completed.The surgeon indicated if the cataract does not "recede operation may be performed".No additional information is expected.

Manufacturer Narrative

The lot complaint history was reviewed.This is the second complaint for the finished goods lot and for this issue for this lot.The device history record shows the product was released per specifications.Three used and three unopened paks were returned and visually inspected; no obvious defects were found.Viscoelastic substance was observed in the fluid lines of the used cassettes.The balls in the check valves of the drip chambers moved freely per specification.The non-invasive flow sensor (nifs) on the cassette housings were in good condition.A calibrated console representing the current software version was used to test the opened samples.The laser emitting diode (led) rings on the console turned green as the probe connectors were engaged to the console indicating the proper communication between the probes and the console.The samples could prime and pass intraocular pressure (iop) calibration successfully.The infusion, irrigation, and aspiration pressure were measured at multiple set points and met specifications.Toggling the infusion and the fluid/air exchange (f/ax) modes, fluid and air flowed from the cassette to the infusion line continuously without any bubble in various settings in all sub modes.The samples were able to pass all functional and performance testing.The samples met specifications.No anomalies were observed during priming.No system message code was generated during testing.Fluid flowed from the balanced salt solution (bss) bottle to the drain bag without any interfering.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.Cleaning process was able to be performed after functional test had completed.The root cause of the customer's complaint could not be established; the returned samples functioned per specifications.After an investigation of this complaint, it has been determined that the samples functioned per specifications; therefore, no corrective action is required at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.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
• MDR Report Key: 7770579
• MDR Text Key: 116699024
• Report Number: 2028159-2018-01681
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• 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: 08/13/2018
• Date Manufacturer Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK
• Patient Outcome(s): Other
• Patient Age: 48 YR