MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CTR PUREPOINT; LASER, OPHTHALMIC

Model Number PUREPOINT

Device Problems No Display/Image (1183); Operating System Becomes Nonfunctional (2996)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2014

Event Type  malfunction  

Event Description

A surgeon reported the system became unavailable with a "disordered screen" during a laser procedure.The procedure was completed using an alternate laser system with no impact 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 additional reportable info becomes available.(b)(4).

• Brand Name: PUREPOINT
• Type of Device: LASER, OPHTHALMIC
• 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 south freeway, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4181104
• MDR Text Key: 19301514
• Report Number: 2028159-2014-01894
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PUREPOINT
• Device Catalogue Number: 8065950597
• Other Device ID Number: 1.04_BLD_0043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2009
• 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