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

Model Number TABLETOP

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2015

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 addition reportable information becomes available.(b)(4).

Event Description

A customer reported the unit was locking when stepping on the foot pedal during a vitrectomy procedure.The event did not prevent the conclusion of the procedure.There was no harm to the patient.Additional information has been requested.

Manufacturer Narrative

No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.The system was manufactured on november 20, 2010.Based on qa assessment, the product met specifications at the time of release.The footswitch was manufactured on october 18, 2010.Based on qa assessment, the product met specifications at the time of release.Footswitch was received for evaluation.An assessment of the returned sample revealed the left and right heel switches would stick when pressed.The left heel switch was opened up and dried balanced saline solution (bss) ingress was seen on the pin and pin hole.The right heel switch was unable to be opened due to a stuck screw.Evidence of bss ingress indicates the same cause as the left heel switch.There was no information on the system.The root cause of the reported event can be attributed to bss ingress on the pins of the heel switches, causing them to stick.An internal investigation has been opened to address the bss issue.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The system was examined and the reported event was replicated.The footswitch was replaced to resolve the issue.The system was tested and found to meet product specifications.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.The system was manufactured on november 20, 2010.Based on qa assessment, the product met specifications at the time of release.The footswitch was manufactured on october 18, 2010.Based on qa assessment, the product met specifications at the time of release.The system was found to meet specifications.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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5267434
• MDR Text Key: 32883045
• Report Number: 2028159-2015-09802
• 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: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2016

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 Expiration Date: 11/19/2020
• 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?: No
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 12/04/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/01/2016; 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2010
• 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