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

Model Number TABLETOP-JAPAN

Device Problems Unstable (1667); Device Displays Incorrect Message (2591); Output Problem (3005)

Patient Problems Rupture (2208); Rupture (2208); Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 09/11/2018

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 several system messages displayed.The surgeon stated that the anterior chamber seemed slightly unstable but proceeded with surgery.A system message indicated there was no more irrigation fluid available even though the balanced saline solution bottle was not empty the bottle was exchanged.The surgeon decided to alter the procedure from a phacoemulsification with aspiration and intraocular lens implant (iol) to an extracapsular cataract extraction with iol.A posterior capsule rupture was noticed and a vitrectomy was performed and sutures were used to close the wound.

Manufacturer Narrative

The surgeon reported a system message [no more irrigation fluid available.Press [change] to change infusion/irrigation bottle.] displayed during testing for set up.The system message indicated there was no more irrigation fluid available even though the balanced saline solution bottle was not empty.The bottle was exchanged.The surgeon stated that the anterior chamber seemed slightly unstable but proceeded with surgery.The surgeon changed the procedure from a phacoemulsification with aspiration and intraocular lens implant (iol) to an extracapsular cataract extraction with iol.A posterior capsule (pc) rupture was noticed and a vitrectomy was performed.The wound was sutured.The surgeon completed a questionnaire and noted the anterior chamber was unstable during nuclear fragmentation.The surgeon was unfamiliar with the system.During i/a the pc tear was noticed and the surgeon tried to complete i/a.During i/a the vitreous body passed through the tear.The surgeon requested that the bottle height be adjusted.The surgeon asked the nurse to raise the bottle while he was looking through the microscope.The nurse noted the button to move the bottle up and down could not be pressed on the screen.The setting was done outside the eye.The irrigation was confirmed.An anterior vitrectomy was performed.The wound was closed with 8-0 silk.The operator¿s manual includes the warnings: good clinical practice dictates the testing for adequate irrigation, aspiration flow, and operation as applicable for each handpiece prior to entering the eye.Visually confirm that adequate infusion flow is occurring prior to attachment of the infusion cannula to the eye.When using the vision system in a pressurized infusion/irrigation mode, or with iop control feature enabled, users need to take precautions to not use irrigating solution or other infusion/irrigation mediums from pliable, collapsible containers (i.E.Bags).The system, when used in these pressurized modes, forces pressure into the infusion/irrigation container in order to force the solution out of the container and into the cassette.The pressure employed by the system may cause some infusion/irrigation bags to rupture and cause disruption of the surgical procedures.Only approved glass containers and bags should be used with the vision system when employing modalities of pressurized infusion/irrigation.The system includes system advisories which contains a ¿change bottle¿ button, to advise the customer to replace the bottle.The company service representative examined the system, but was unable to replicate the reported events on multiple visits.Unrelated to the reported event, the company service representative upgraded the system software.The system was the tested and met all product specifications.The system was manufactured on june 25, 2018.Based on qa assessment, the product met specifications at the time of release.The system was found to meet specifications; therefore, the root cause of the reported events cannot be determined conclusively.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: 7967538
• MDR Text Key: 123796034
• Report Number: 2028159-2018-02144
• Device Sequence Number: 0
• Product Code: HQC
• 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: 01/30/2019
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• 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?: No
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR