MAUDE Adverse Event Report: PINKYPARADISE CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problem Corneal Abrasion (1789)

Event Date 10/23/2021

Event Type  Injury  

Event Description

Patient came to our clinic for emergency visit after complications due to wearing contacts that were sold to her without a prescription. The result was a very severe corneal abrasion. Fda safety report id # (b)(4).

Event Description

Additional information is added to the report number mw5104966 on 12/20/2021. Mfr unknown.

• Brand Name: PINKYPARADISE CONTACT LENSES
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• MDR Report Key: 12703914
• Report Number: MW5104966
• Device Sequence Number: 1
• Product Code: LPL
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Patient Outcome(s): Other