MAUDE Adverse Event Report: UNKNOWN WALDO CONTACT LENS LENSES, SOFT CONTACT, DAILY WEAR

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Conjunctivitis (1784); Inflammation (1932); Keratitis (1944); Neovascularization (1978); Visual Impairment (2138)

Event Date 08/07/2020

Event Type  Injury  

Event Description

This patient came in wearing waldo lenses that were never prescribed to her. Her last eye exam was in 2015 and per patient used her glasses prescription to order contacts. The contact lenses have caused reduced vision as they do not appear to be a toric lens which the patients needs. They have also caused corneal neovascularization, papillary conjunctivitis and punctate keratitis. If these contacts were prescribed by an optometrist/ophthalmologist and had routine follow up care these events may have not occurred. Fda safety report id # (b)(4).

• Brand Name: WALDO CONTACT LENS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10407448
• MDR Text Key: 203291649
• Report Number: MW5096075
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 08/13/2020 Patient Sequence Number: 1