MAUDE Adverse Event Report: CARL ZEISS MEDITEC INC. ZEISS LASER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dry Eye(s) (1814); Vitreous Floaters (1866)

Event Date 02/04/2018

Event Type  Injury  

Event Description

I went through relex smile lasik at (b)(6) hospital (b)(6).I thought i would save my expenses and doctor said i have perfect eyes, but after 14 days i suffered from irregular cornea and floaters in my both eyes and doctor never cared.Told me it's my mind, i see ghost images at night, now very bad and have a lot of dryness trying to recover from yoga but i wasn't a perfect candidate.He did this surgery and harmed my healthy eyes, never told me about side effects.

• Brand Name: ZEISS LASER
• Type of Device: ZEISS LASER
• Manufacturer (Section D): CARL ZEISS MEDITEC INC.
• MDR Report Key: 7889329
• MDR Text Key: 120979982
• Report Number: MW5079886
• Device Sequence Number: 0
• Product Code: OTL
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• 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): Disability
• Patient Age: 20 YR
• Patient Weight: 62