MAUDE Adverse Event Report: LASIK LASIK NONE

Device Problem Insufficient Information (3190)

Patient Problems Vitreous Floaters (1866); Burning Sensation (2146); Foreign Body In Patient (2687)

Event Date 07/25/2005

Event Type  Other  

Event Description

Add'l info rec'd from rptr (b)(4) 2011: you are going to tell me this is a civil case and you are right but i want you to make an issue that people are having problems with this type of operation and not being reported to your company. I did go back to them only 3 times when i was told about the floater that i would have to live with them. When i requested all of my files there was nothing in the file about this problem and now, talking with the company rep (b)(4) (rude) first i never returned and now saying that i returned 6 times this is all a lie. What i want your office to do is look into these practices of not reporting problems to your office. I understand that back in 2005 all problems should have been reported to your office but i was not and how many others were not reported? the company and doctor should be penalized for not following regulation. What do i have to do to get your office/company to go after this company? company name and address is as follow. (b)(4). I did have this done in (b)(6) a company out let. (b)(6) knows who i am and she was told that i am reporting this to the state and to the fda. Please advise what can be done about this company that lies to me on the phone about my status and my files. I am sorry this is not right if you wish for me to send a copy of the files they sent to me i will provide them.

Event Description

I have tried this before. I had lasik done and i reported 3 times that i had floaters in my left. On the 3rd time, i was told i had to live with them. Why was i not told about this condition? there is nothing in my file about this problem which i am talking about. I bought an insurance warranty. I have requested the (b)(6) returned but they have refused to return my money. I am (b)(6) and cannot afford to go see an eye dr. I have other problems as crystals in that eye and must use eye drops also or my eye burns. There is paper work in my file i never saw before. I have tried to call your place several times, but i get blown off by your operators being rude to a person with a hearing problem. And i do mean rude, ask a girl named (b)(6) how rude she was; oh i am sure you will look her up. (b)(6).

• Brand Name: LASIK
• Type of Device: NONE
• Manufacturer (Section D): LASIK
• MDR Report Key: 2016305
• MDR Text Key: 19272649
• Report Number: MW5019699
• 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,Followup
• Report Date: 03/07/2011

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/07/2011
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2011
• Is the Reporter a Health Professional?: No