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

Model Number TABLETOP-CHINA

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2019

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 the cassette leaked after being installed onto the system and the aspiration "part" was found to be cracked during testing.There was no patient involvement and no harm to the operating room staff.

Manufacturer Narrative

The lot complaint history was reviewed, this is the sixth complaint for the finish goods lot; however, the second for this issue for this lot.The device history record shows the product was released per specifications.As no sample was returned for evaluation; the condition of the product could not be verified.A sample was not returned and no lot information is available, therefore, the root cause for the customer reported event cannot be determined.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.(b)(4).

Manufacturer Narrative

Additional information provided in d.10., h.3., h.6.And h.10.Correction provided in d.4.The returned sample was visually turbid, in returned condition.No obvious defects were observed.It was noted a section of the auxiliary suction line was not returned.Additionally the infusion cannula assembly was not returned.No damage was found on the infusion and aspiration chambers on the pinch plate.All the elastomers were installed on the pinch plate properly.A full product pressure leak test was then conducted on the cassette utilizing an external pressure source and no cassette leakage was detected.A calibrated console representing the current software version was used to test the sample.The light emitting diode (led) rings on the console turned green as the probe connectors were engaged to the console indicating the proper communication between the probe and the console.The ball in the check valve of the drip chamber moved freely per specification.The sample could prime and pass intraocular pressure (iop) calibration successfully.No anomalies were observed during priming.No system message code was generated during testing.The infusion pressure was measured at multiple set points throughout the console range and met specifications.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 met specifications.No leakage was detected or damage observed during laboratory evaluation of the sample.After investigation of this complaint, it has been determined that this sample met specifications; therefore, no corrective action is required at this time.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: 8802316
• MDR Text Key: 151578886
• Report Number: 2028159-2019-01307
• 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,Followup
• Report Date: 06/24/2020

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: TABLETOP-CHINA
• Device Catalogue Number: 8065751536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 10/03/2019; 06/11/2020
• Supplement Dates FDA Received: 10/16/2019; 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK.