MAUDE Adverse Event Report: RELEX SMILE APPARATUS; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); No Code Available (3191)

Event Date 11/10/2016

Event Type  Injury  

Event Description

Relex smile surgery, both eyes.Tried to solve astigmatism but led to severe dry eye and corneal denevation.Still suffering refractive dysfunction.

• Brand Name: RELEX SMILE APPARATUS
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• MDR Report Key: 6787697
• MDR Text Key: 82593621
• Report Number: MW5071525
• Device Sequence Number: 0
• Product Code: OTL
• Combination Product (y/n): N
• Reporter Country Code: ES
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 43 YR
• Patient Weight: 73