MAUDE Adverse Event Report: LASIK; POWERED LASER SURGICAL INSTRUMENT

Device Problem Suction Problem (2170)

Patient Problems Dry Eye(s) (1814); Vitreous Floaters (1866); Pain (1994); Visual Disturbances (2140); Halo (2227)

Event Date 10/21/2020

Event Type  Injury  

Event Description

Reporter claims to have underwent a laser lasik surgery at the (b)(6) center using a wavelength device.Patient claims to experience pain, dry eye, seeing halos, starbursts, and floaters, which have been progressively worsening over the past month.Patient claims they did not receive adequate information regarding side effects of the procedure.The patient believes there was an issue with the pressure and suction of the device.

• Brand Name: LASIK
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• MDR Report Key: 10927509
• MDR Text Key: 219155715
• Report Number: MW5098161
• Device Sequence Number: 1
• Product Code: GEX
• 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: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR