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

Model Number TABLETOP

Device Problem Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2015

Event Type  malfunction  

Manufacturer Narrative

A service visit was performed.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21cfr 803.56 when additional reportable information becomes available.Additional information has been requested but not received to date.The manufacturer internal reference number is: (b)(4).

Event Description

A doctor of ophthalmology reported that during the phacoemulsification the eye was very unstable.This had also been confirmed for this system by another surgeon.The reporter and his colleague observed this phenomenon only with this system.With a high position of the bottle the surgery could be continued.The event occurred during several surgeries.The patient impact is unknown.Additional information has been requested but not received to date.This is one of two reports being filled for this facility, this report is for the first patient.

Manufacturer Narrative

The system was examined and the reported event was not replicated.The system was tested and found to meet product specifications.The system met specifications at the time of release.The root cause of the reported events cannot be determined conclusively.As the customer did not retain the finished goods consumable lot number, device history lot (dhr) and lot history of the anterior pak could not be reviewed.The customer did not retain a sample for this complaint report, as such, functional testing could not be conducted.A sample was not returned for this complaint.Without a returned sample, it is not possible to isolate the root cause.(b)(4).

Event Description

This is one of three reports being filled for this facility.This is the first report for the intraocular pressure issue, this report is for the patient with known surgery date.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional clarifications were received.The patient impact is unknown.

• 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: 5140038
• MDR Text Key: 28369269
• Report Number: 2028159-2015-08861
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Remedial Action: Other
• Type of Report: Followup,Followup
• Report Date: 01/12/2016

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/08/2016; 01/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2013
• 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