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

Model Number TABLETOP-JAPAN

Device Problem Unstable (1667)

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

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 doctor of ophthalmology reported during a vitrectomy procedure the aspiration was bad and the anterior chamber was unstable.The surgery was completed.There was no impact to the patient.Additional informational is not expected.

Manufacturer Narrative

The customer reported that the system was involved in a surgery where the anterior chamber was unstable.In addition, the aspiration was poor during times of the surgery.The company service representative examined the system and did not indicated finding any issues associated to the reported event.The fluidics module and illuminator module were replaced.The system was then tested and met all product specifications.The system was manufactured on december 19, 2011.Based on qa assessment, the product met specifications at the time of release.A review of complaints for the last 24 months did not indicate any additional related reports for this system serial number.The constellation operators manual notes the system is a closed loop system that adjusts iop.The iop control cannot replace the standard of care in judging iop intraoperatively.The surgeon must continue the common practice of informally judging the following: finger palpation on the globe, tactile feedback of the surgical instruments, retinal vessel perfusion/pulsations, and presence of corneal edema.If the surgeon believes the iop is not responding to the system settings and is dangerously high, the surgeon can do one or more of the following as they deem appropriate in this situation (with care to avoid sudden hypotony): close the infusion stopcock, pinch the infusion line, and/or remove the infusion line.The root cause of the reported event cannot be determined conclusively.(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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5107802
• MDR Text Key: 27062657
• Report Number: 2028159-2015-08610
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 11/19/2015

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: 3.00.61
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2011
• 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