MAUDE Adverse Event Report: LASIK ALLEGRETTO

Device Problem Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Dry Eye(s) (1814); Blurred Vision (2137); Visual Disturbances (2140)

Event Date 12/14/2012

Event Type  Injury  

Event Description

I had all laser lasik 8 months ago from lasikplus.Lasikplus glossed over the risks and recovery and did not provide accurate or thorough pre-lasik education.I was told the following: recovery period is 1-3 months with temporary starbursts that go away and temporary vision fluctuations that go away, the rate of under correction is 5%, cornea ectasia was briefly discussed with me and dismissed as a rare complication.This messaging is flawed: the flap cut by lasik never heals - this was not even mentioned to me.The true recovery period is much longer than 3 months, a realistic time-table was not provided to me.Starbursts were marketed to me as temporary but the reality is that they can be permanent and are not curable.Dry eye was not explained to me.There is no cure for dry eye.The 5% under-correction rate is misleading in that it is only a part of the story.The other part is that you could be overcorrected, or with an induced astigmatism, or with eyes that are not the same prescription as each other - none of which was discussed with me.I was not adequately pre-screened for dry eye nor was i educated about dry eye pre-operatively.My pupil size was not discussed with me and its potential impact on vision was not reviewed with me.My near vision - reading vision - was not evaluated pre-operatively.The lasik manufacturer's literature was not provided to me.I was not consulted with regarding my other options such as prk, lasek, contact lenses, or glasses.I was not consulted with on my personal goals and reasons for having lasik to ensure that these were in-line with what is possible with lasik.I now have fluctuating side blur on the temporal side of one eye.I have dry eye and am now on expensive therapies with a dry eye specialist.I have starbursts in low light/ darkness on light sources.These are annoying and disturbing to my vision.I have an astigmatism in one eye.I never had any of these problems prior to lasik.

• Brand Name: LASIK ALLEGRETTO
• Type of Device: LASIK ALLEGRETTO
• MDR Report Key: 3360490
• MDR Text Key: 3743103
• Report Number: MW5031906
• Device Sequence Number: 1
• Product Code: LZS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Patient Outcome(s): Disability