MAUDE Adverse Event Report: LASIK LASIK

Device Problem Insufficient Information (3190)

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

Event Date 01/22/2013

Event Type  Injury  

Event Description

I had lasik on both eyes in 2005 and developed cataracts in both eyes in 2011. I had cataract surgery in both eyes in 2013 as my vision was deteriorating rapidly. After both surgeries were complete, i was unable to see close up clearly and became extremely farsighted. I had to have a third surgery to implant a second lens in my left eye to correct the power. My doctor told me that this inability for an accurate measurement for iol after lasik was common. I am currently recuperating from this third surgery and am hoping for improved vision. I used the same doctor for both procedures. He was up front with me regarding the lasik as a potential cause of my cataracts. Dates of use: (b)(6) 2005. Reason for use: myopia.

• Brand Name: LASIK
• Type of Device: LASIK
• Manufacturer (Section D): LASIK
• MDR Report Key: 3164508
• MDR Text Key: 18249512
• Report Number: MW5030483
• 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: 06/06/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2013
• 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?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 06/06/2013 Patient Sequence Number: 1