MAUDE Adverse Event Report: LENSAR INC LENSAR LASER SYSTEM -FS 3D

Catalog Number 70-00005-001

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/08/2015

Event Type  Other  

Event Description

A customer reported to a lensar distributor clinical application specialist a hardware stop error during surgery and during the phaco surgery the surgeon noticed that a portion of the fragmentation was etched onto the cornea.

• Brand Name: LENSAR LASER SYSTEM -FS 3D
• Type of Device: LENSAR LASER SYSTEM -FS 3D
• Manufacturer (Section D): LENSAR INC; orlando FL
• Manufacturer Contact: keith peck ; 2800 discovery rd.; suite 100; orlando, FL 32826 ; 8885756412
• MDR Report Key: 4737458
• MDR Text Key: 5702622
• Report Number: 3009026057-2015-00016
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 70-00005-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2013
• 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