MAUDE Adverse Event Report: LASIK

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); Vitreous Floaters (1866); Corneal Clouding/Hazing (1878); Blurred Vision (2137); Visual Impairment (2138); Vitreous Detachment (2445)

Event Date 06/06/2014

Event Type  Injury  

Event Description

In (b)(6) 2008, i had lasik. Two years later, i had a posterior vitreous detachment in the left eye and now six years later, i have had a posterior vitreous detachment in the right eye. I have very large black floaters in both eyes and a haze or cloudy area in both eyes that make it impossible to focus clearly. Glasses will not correct this because the cloudiness is in my vitreous. I was myopic presurgery with both eyes being about a -6 dpt. Nobody advised me that this could be a side effect. I now feel like i am partially blind. I've also been on restasis for six years and have just switched to a autologous serum eyedrops for my dry eye. The eyedrops have improved the health of my cornea but it does not help with the posterior vitreous detachment. If only i had a time machine to go back and not choose this surgery. Why wasn't i told this could be a risk. Now i worry in the next few years what the next surprise will be from this nightmare of a surgery called lasik. I don't understand why it is legal.

• Brand Name: LASIK
• Type of Device: LASIK
• MDR Report Key: 3926579
• MDR Text Key: 4580373
• Report Number: MW5037097
• 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: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other

Patient Treatment Data

Date Received: 07/07/2014 Patient Sequence Number: 1