MAUDE Adverse Event Report: HUBBLE / ST SHINE OPTICAL HUBBLE CONTACTS

Model Number -12

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Visual Impairment (2138)

Event Date 03/10/2018

Event Type  No Answer Provided  

Event Description

Hubble sold me the wrong contact lenses and did not verify my contact lens prescription.The contact lenses hurt when i wore them and i could not see well out of them.I could have gotten in a car accident.

• Brand Name: HUBBLE CONTACTS
• Type of Device: HUBBLE CONTACTS
• Manufacturer (Section D): HUBBLE / ST SHINE OPTICAL
• MDR Report Key: 7366061
• MDR Text Key: 103464305
• Report Number: MW5076054
• 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: Patient
• Type of Report: Initial
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Device Operator: No Information
• Device Expiration Date: 11/30/2021
• Device Model Number: -12
• Device Catalogue Number: 8.6 14.2
• Device Lot Number: Y16247
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 64