MAUDE Adverse Event Report: LASIK EXCIMER LASER SYSTEM

Device Problem Leak/Splash (1354)

Patient Problem Dry Eye(s) (1814)

Event Date 05/22/2018

Event Type  Injury  

Event Description

I developed dry eyes in (b)(6) 2018 due to leak.

• Brand Name: LASIK EXCIMER LASER SYSTEM
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 7930310
• MDR Text Key: 122785362
• Report Number: MW5080319
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 28 YR