MAUDE Adverse Event Report: LASIK SURGERY

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Cataract (1766); Dry Eye(s) (1814); Pain (1994); Visual Impairment (2138)

Event Date 04/01/2014

Event Type  Injury  

Event Description

I had lasik surgery on both eyes in (b)(6) 2012.By (b)(6) 2013, the sight in my left eye began to greatly deteriorate and my lasik surgeon performed an enhancement that did not work.I began experiencing cloudiness and pain in my left eye.When i went back he told me that i had an aggressively growing cataract in my left eye.I am only (b)(6) and i am scheduled to have the cataract in my left eye removed next week, i have also suffered from extreme dry eye since the lasik surgery.I am extremely disappointed that this was not mentioned as a possible complication from the lasik surgery.Had i known i could possibly develop cataracts, i would not have elected to have the lasik procedure.

• Brand Name: LASIK SURGERY
• Type of Device: LASIK
• MDR Report Key: 3731808
• MDR Text Key: 16804905
• Report Number: MW5035471
• 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: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2014
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 88