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

Model Number TABLETOP

Device Problems Unstable (1667); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2015

Event Type  malfunction  

Event Description

A customer reported that a system displayed a system message and the aspiration was unstable during the phacoemulsification portion of a surgery.The surgery was completed after exchanging the system.There was no patient harm.

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).

Manufacturer Narrative

The system was examined.The company representative did not indicate finding any issues that would be associated with the reported event.The system was tested and found to meet product specifications.The system was manufactured on september 25, 2013.Based on qa assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

A fluidics was received for evaluation.A visual assessment of the returned sample did not reveal any obvious visual nonconformity.The returned sample was installed into a calibrated hotbed system and the system was booted up without any system message (sm) or abnormalities noted.The returned sample was then tested and was found to meet specifications.The customer reported event was not able to be replicated.The system and the returned sample met specification.Therefore, the root cause 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: 4894016
• MDR Text Key: 6067494
• Report Number: 2028159-2015-06833
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

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
• Device Catalogue Number: 8065751150
• Other Device ID Number: 3.00.61
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 07/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2013
• 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