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

Model Number LXT

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

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

An ophthalmic surgeon reported that the device did not allow the air to flow when changing from liquid to air during a vitrectomy procedure.The product was replaced with another and the procedure was completed.There was no harm to the patient.Additional information was requested; however, none has been received to date.

Manufacturer Narrative

The lot complaint history was reviewed, this is the second complaint for the finish goods lot; however, the first for this issue.The device history record showed the product was released per specifications.The returned sample was visually inspected and no obvious defects were observed.The sample was tested on a console and it generated system message code indicating a failure of the auto infusion valve to actuate.An external pressure source was then used to perform a cracking pressure test.The pressure was incrementally increased until the valve actuated.The sample was non-conforming due to the higher than expected cracking pressure.The root cause of the customer¿s complaint is the failure of the device to switch from fluid to air whereby the aiv failed to open or had a high cracking pressure (pressure required to open the aiv to allow air passage).Action will not be taken based on this occurrence.This problem is occurring at a low level, which is considered infrequent for issues of this nature at this time.(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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6132328
• MDR Text Key: 61297277
• Report Number: 2028159-2016-05438
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: Initial,Followup
• Report Date: 04/10/2017

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: LXT
• Device Catalogue Number: 8065751145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: COMBINED PACK 23 GAUGE 5000 CUTS PER MINUTE
• Patient Outcome(s): Other