MAUDE Adverse Event Report: LASER FOR EYE SURGERY

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  Injury  

Event Description

I underwent lasik surgery around 1999. A few yrs later, i was diagnosed with a cataract in my left eye. I put off cataract surgery as long as possible; and now at age (b)(6), i have cataracts in both eyes. My vision is so affected that i have fallen several times because i could not see objects on the floor in nighttime lamp light. To make matters worse, my cataract surgeon explained that the cataract surgery will be difficult because the medical equipment used to determine the refraction needed in the replacement lens uses a ratio of two surfaces in a non-lasik eye. Thus, the surgeon will have to use other formulas and manually determine what strength the implanted lens should be basically, he will have to guess. If lasik surgery is going to be performed w/o telling pts that early cataracts are more likely to develop, at least tell the pts to keep a copy of their lasik surgical records so that subsequent cataracts surgery can be performed w/o "estimating" or guessing what replacement lens is needed to restore sight.

• Brand Name: LASER FOR EYE SURGERY
• Type of Device: LASER FOR EYE SURGERY
• MDR Report Key: 3599060
• Report Number: MW5033999
• 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: 01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Patient Age: 50 YR
• Patient Outcome(s): Other