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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Date 03/23/2018

Event Type  Injury  

Event Description

Pt reported with significant discomfort, previously had used hubble contacts, diagnosis was a dellen.

• Brand Name: HUBBLE CONTACT
• Type of Device: SOFT CONTACT LENSES
• Manufacturer (Section D): ST. SHINE OPITCAL CO., LTD.
• MDR Report Key: 7464221
• MDR Text Key: 106801492
• Report Number: MW5076760
• 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
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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): Required Intervention
• Patient Age: 30 YR