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

Model Number LT-JAPAN

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2017

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 air mixed in the patient's eye during a procedure, making it difficult to perform surgery.The procedure was completed without product replacement.No patient harm during this event.

Manufacturer Narrative

The lot complaint history was reviewed; this is the first complaint for the finish goods lot and first for this issue.The device history record shows the product was released per specifications.A customer reported that air mixed in the patient's eye during surgery.The wet returned sample was visually inspected.A third party supplier stopcock was connected to the auto stopcock and the infusion cannula line.The customer should be reminded the directions for use states mismatch of consumable components and/or use of settings not specially adjusted for a particular combination of consumable components may create potentially hazardous fluidics imbalance.The sample was then tested on a constellation system and could prime and pass intraocular pressure calibration successfully.No anomalies were observed during priming.No fluid or air leak was detected from the infusion air line during the priming process.The infusion pressure was measured at multiple set points throughout the console range 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.No message code appeared on the screen.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.The root cause of the customer's complaint could not be established; the returned sample met specifications.It was noted during the inspection a non-alcon stopcock was utilized with the alcon consumable device.After a thorough investigation of this complaint, it has been determined that this sample met specifications; therefore, no corrective action is required at this time.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.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
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7076093
• MDR Text Key: 93629735
• Report Number: 2028159-2017-04446
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LT-JAPAN
• Device Catalogue Number: 8065752042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other