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

Model Number TABLETOP-JAPAN

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2018

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.(b)(4).

Event Description

An ophthalmic surgeon reported that a bubble came into a patient's eye from the infusion line during surgery.It was confirmed visually that the bubble entered into the infusion line from inside the cassette.The procedure was completed after aspirating the bubble and without product replacement.There was no patient harm.

Manufacturer Narrative

The lot complaint history was reviewed.This is the tenth complaint for the finish goods lot; however, this is the first complaint for this issue for this lot.The device history record shows the product was released per specifications.The returned sample was visually inspected.The sample was moldy and the infusion fluid path was clogged with balanced salt solution (bss) crystal.The filters on the cassette were saturated with surgical solution.The sample was tested several times on different days, but failed priming.The system message code 3475 appeared on the console screen.Using a syringe to purge the fluid path of the cassette and the manifolds, the same failure occurred.Testing could not be performed due to the wet filters.The cassette was dried and then visually inspected again, no obvious defects were found.The ball in the drip chamber¿s check valve moved freely per specification.The non-invasive flow sensor (nifs) on the cassette housing was in good condition.A calibrated console representing the current software version was used to test the sample.The sample could prime, tune, 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 sample was able to pass all functional and performance testing.The sample met specifications.No system message code was generated during testing.Fluid flowed from the 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 sample functioned per specifications.After a thorough investigation of this complaint, it has been determined that this sample 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: 7564774
• MDR Text Key: 110180781
• Report Number: 2028159-2018-01133
• 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: 09/12/2018

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: TABLETOP-JAPAN
• Device Catalogue Number: 8065751817
• Other Device ID Number: 380657518173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 09/11/2018
• Supplement Dates FDA Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK
• Patient Outcome(s): Other