MAUDE Adverse Event Report: ALCON LABORATORIES, INC. ALCON ALLEGRETTO WAVELIGHT CUSTOM LASIK

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Dry Eye(s) (1814); Emotional Changes (1831); Pain (1994)

Event Date 02/21/2006

Event Type  Injury  

Event Description

I have chronic aqueous deficient dry eye aka neurotrophic keratopathy or refractory dry eye. My eyes do not tear when they are dry or come into contact with irritants and allergens. This is an extremely painful and degenerative condition though i don't think i will be around to see exactly how bad it gets because i intend to end my life soon. My doctor claims that it is not possible for this to be a result of lasik. However, when pressed he said that up to 40% of lasik patients have some degree of residual dry eye. He is full of contradictions. It depends what you're asking him and in what context. The answer changes regularly. It took me 6 years to find a doctor that finally told me that this condition is in fact due to lasik surgery. This is due to a concerted effort by ophthalmologists to cover up for each other. Even though they knew better they sent me on a 6 year quest to find out what i should have been told before the surgery. Lasik causes extreme dry eyes in many people, especially people like me with high risk factors.

• Brand Name: ALCON
• Type of Device: ALLEGRETTO WAVELIGHT CUSTOM LASIK
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 2614700
• MDR Text Key: 2669059
• Report Number: MW5025722
• Device Sequence Number: 1
• Product Code: LZS

Combination Product (Y/N)

• 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: 06/06/2012

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/06/2012
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No

Device Operator

• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No
• Is this a Reprocessed and Reused Single-Use Device?: No

Patient TREATMENT DATA

Date Received: 06/06/2012 Patient Sequence Number: 1

Treatment

KLONOPIN 1MG; CELEXA 40MG; REMERON 15MG