MAUDE Adverse Event Report: SCLERAL CONTACT LENSES; LENS, CONTACT (OTHER MATERIAL) - DAILY

Device Problem Use of Device Problem (1670)

Patient Problem Keratitis (1944)

Event Date 08/25/2021

Event Type  Injury  

Event Description

Developed keratitis due to scleral lenses, also showering in them.Fda safety report id# (b)(4).

• Brand Name: SCLERAL CONTACT LENSES
• Type of Device: LENS, CONTACT (OTHER MATERIAL) - DAILY
• MDR Report Key: 12547588
• MDR Text Key: 274116705
• Report Number: MW5104281
• Device Sequence Number: 1
• Product Code: HQD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR