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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 52