MAUDE Adverse Event Report: ST. SHINE OPTICAL CO., LTD. HUBBLE CONTACT LENSES; LENSES, SOFT CONTACT, DAILY WEAR

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2018

Event Type  No Answer Provided  

Event Description

A pt of mine ordered hubble contact lenses without an rx for hubble contact lenses.I was not contacted by hubble to verify an rx.My pt did not suffer an adverse affect, but these contact lenses are made with outdated material and are not fit correctly.They have the potential to cause long term visual effects including loss of vision.Infection and potential blindness.On (b)(6) 2018 i saw the pt for an eye exam and performed a slit lamp examination on her corneas.I also performed a contact lens fitting and evaluation.

• Brand Name: HUBBLE CONTACT LENSES
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): ST. SHINE OPTICAL CO., LTD.
• MDR Report Key: 7979560
• MDR Text Key: 124500627
• Report Number: MW5080671
• 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: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• 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: 31 YR
• Patient Weight: 61