ZEISS LASER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-18 for ZEISS LASER manufactured by Carl Zeiss Meditec Inc..

Event Text Entries

[120979982] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5079886
• MDR Report Key: 7889329
• Date Received: 2018-09-18
• Date of Report: 2018-09-15
• Date of Event: 2018-02-04
• Date Added to Maude: 2018-09-19
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 0

• Brand Name: ZEISS LASER
• Generic Name: ZEISS LASER
• Product Code: OTL
• Date Received: 2018-09-18
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: CARL ZEISS MEDITEC INC.

Device Sequence Number: 1

• Brand Name: ZEISS LASER
• Generic Name: ZEISS LASER
• Product Code: LZS
• Date Received: 2018-09-18
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CARL ZEISS MEDITEC INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2018-09-18