MAUDE Adverse Event Report: LASIK EYE SURGERY

Model Number DON'T KNOW

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 03/09/2018

Event Type  Injury  

Event Description

Was the worst experience in my life when the numbing eye drops went into my eyes and the laser started.It felt like acid was burning my eyes, i screamed and was kicking the chair but they just told me to calm down.I have had pain everyday since and today is (b)(6) 2019.Rx meds: a lot now, but none before surgery.

• Brand Name: LASIK EYE SURGERY
• Type of Device: LASIK EYE SURGERY
• MDR Report Key: 8286638
• MDR Text Key: 134632099
• Report Number: MW5083460
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2019
• Device Model Number: DON'T KNOW
• Device Catalogue Number: DON'T KNOW
• Device Lot Number: DON'T KNOW
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 37 YR