MAUDE Adverse Event Report: LASIK

Device Problem Insufficient Information (3190)

Patient Problems Vitreous Floaters (1866); Retinal Injury (2048)

Event Type  Injury  

Event Description

I had lasik on my right eye and soon after developed large floaters. In addition, i have had five retinal detachments in the eye and may end up legally blind in the eye. Lasik on right eye in 2000.

• Brand Name: LASIK
• Type of Device: LASIK
• MDR Report Key: 2520927
• MDR Text Key: 14889155
• Report Number: MW5024883
• Device Sequence Number: 1
• Product Code: LZS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/02/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2012
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Patient Treatment Data

Date Received: 04/02/2012 Patient Sequence Number: 1