MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CTR CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number LXT

Device Problems Unstable (1667); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2014

Event Type  malfunction  

Event Description

A customer reported that during surgery, a pt's anterior chamber became unstable.The surgery was completed with the same system and accessories.There was no harm to the pt.

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 add'l reportable info becomes available.(b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON - IRVINE TECHNOLOGY CTR; 15800 alton pkwy.; irvine CA 92618
• Manufacturer (Section G): ALCON - IRVINE TECHNOLOGY CTR; 15800 alton pkwy.; irvine CA 92618
• Manufacturer Contact: janet moran ; 6201 s freeway; r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4097949
• MDR Text Key: 4715186
• Report Number: 2028159-2014-01669
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2014

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: 8065751550
• Other Device ID Number: 3.00.61
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/13/2014
• Initial Date FDA Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2010
• 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