MAUDE Adverse Event Report: LASIK NONE

Device Problem Insufficient Information (3190)

Patient Problems Cataract, Induced (1767); Visual Impairment (2138)

Event Date 08/01/1999

Event Type  Injury  

Event Description

In 1999, at the age of (b)(6), i had lasik eye surgery. One year later, i was back in contacts and had developed cataracts in both eyes. In 2000, although the eye doctor could identify my cataracts in both eyes, it did not affect my vision. That changed in 2012 and now at the age of (b)(6), i need to have cataract surgery. I do not have a family history of cataracts. Both of my parents over the age of (b)(6) have not had any signs of cataracts. Lasik was performed by (b)(6).

• Brand Name: LASIK
• Type of Device: NONE
• MDR Report Key: 2659036
• MDR Text Key: 2774205
• Report Number: MW5026173
• Device Sequence Number: 1
• Product Code: LZS

Combination Product (Y/N)

• 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: 07/12/2012

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/12/2012
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: OTHER
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Patient TREATMENT DATA

Date Received: 07/12/2012 Patient Sequence Number: 1