MAUDE Adverse Event Report: UNIDENTIFIED DEVICE; LASER EYE SURGERY

Device Problem Insufficient Information (3190)

Patient Problem Dry Eye(s) (1814)

Event Type  Other  

Event Description

Had laser eye surgery about 6 years ago at the (b)(6).I suffer from chronic dry eyes in which i need to use quality eye drops 10 times per day.I did not have even the slightest dry eyes prior to the procedure.

• Brand Name: UNIDENTIFIED DEVICE
• Type of Device: LASER EYE SURGERY
• MDR Report Key: 3527523
• MDR Text Key: 3999347
• Report Number: MW5033486
• Device Sequence Number: 1
• Product Code: LZS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/15/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2013
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 52