MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) RELEX SMILE REFRACTIVE SURGERY; FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); Keratitis (1944); Visual Impairment (2138); Neuralgia (4413); Increased Sensitivity (4538)

Event Date 07/30/2019

Event Type  Injury  

Event Description

Relex smile refractive surgery to both eyes.Two (2) year post surgery symptoms: severe corneal inflammation, corneal neuralgia, aberrant corneal nerve growth, recurrent superficial punctate keratitis, aqueous deficient dry eyes 2mm schirmer), meibomian gland dysfunction, filamentary keratitis.Corneal hyperaesthesia, evaporative dry eyes, photophobia.Loss of best corrected vision.Fda safety report id # (b)(4).

• Brand Name: RELEX SMILE REFRACTIVE SURGERY
• Type of Device: FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA)
• MDR Report Key: 12589923
• MDR Text Key: 275431718
• Report Number: MW5104442
• Device Sequence Number: 1
• Product Code: OTL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 40 YR
• Patient Weight: 80