MAUDE Adverse Event Report: LASIK; EXCIMER LASER SYSTEM

Model Number LASIK PROCEDURE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Dry Eye(s) (1814)

Event Date 01/09/2019

Event Type  Injury  

Event Description

I had lasik in (b)(6) 2018 from lasik plus.I was asked suitability questions like astigmatism and dry eye that i already had prior to lasik.The surgeon told me that i am perfect candidate and had me signed the waivers and performed laisk.Immediately after lasik i had severe dry eye and reported to lasik plus surgeon and they said it's nothing serious and will heal with time.As time passed it became worse and from the beginning of 2020, i have been trying to see lasik plus surgeon, but they been unavailable to accommodate to see me due to covid reasons.I did speak with an ophthalmologist specialized in post lasik and been told that i have severe conditions of dry eye and i was also not a perfect.I have pre lasik tests and these indicate that i had dry eye spots on my cornea during scans that makes me not a suitable candidate and lasik plus told otherwise that i am a perfect candidate and based on that i signed waiver.Fda safety report id # (b)(4).

• Brand Name: LASIK
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 11065005
• MDR Text Key: 223615546
• Report Number: MW5098507
• Device Sequence Number: 1
• Product Code: LZS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/18/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: LASIK PROCEDURE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 32 YR
• Patient Weight: 73