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

Model Number TABLETOP-CHINA

Device Problem Air Leak (1008)

Patient Problem No Information (3190)

Event Date 11/17/2016

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.(b)(4).

Event Description

A customer reported that the fluid air exchange was lost.Additional information has been requested.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received stating that the event date was (b)(6) 2016 and occurred prior to surgery.There was no patient involvement.

Manufacturer Narrative

Additional information is provided in device available for evaluation?, device evaluated by mfr?, evaluation codes and additional mfr narrative.The system was examined.The company representative did not indicate finding any issues that would be associated with the reported event.However, the company representative did observe that the issue was caused by the customer¿s reuse of the associated consumable pak.The customer will be notified to discontinue this practice and will be provided with directions for use (dfu).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 april 18, 2016.A review of the manufacturing records did not reveal any related non-conformity during manufacturing for this system.Based on qa assessment, the product met specifications at the time of release.The system was found to meet specifications.The root cause of the reported event can be attributed to customer user error by re-using the consumables.(b)(4).

Event Description

A customer reported that the fluid air exchange was lost.Additional information has been requested.Additional information received stating that the event date was (b)(6) 2016 and occurred prior to surgery.There was no patient involvement.

• 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6130912
• MDR Text Key: 61204585
• Report Number: 2028159-2016-05421
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2017

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-CHINA
• Device Catalogue Number: 8065751536
• Other Device ID Number: 3.00.61
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 11/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/06/2016; 02/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other