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

Lot Number 619183

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

Patient Problem No Code Available (3191)

Event Date 04/18/2020

Event Type  Injury  

Event Description

A few weeks ago, i purchased contact lenses online from hubble and upon use this morning (b)(6) 2020, experienced instant loss of facial volume.I wore a pair a few days ago and experienced loss of volume and opened one more container from the box to see if this would happen again.(to note, i just recently submitted a fda complaint in regards to softmed 55 lenses resulting in this issue as well.As provided in this and other complaints made, i am the subject of a very malicious government operation and a lot of the things i buy, to include prescription medications have resulted in unwanted issues such as this and it is quite obvious to me that this is being done with government resources.Regardless of such, no one has the right to harm me or alter anything about me, therefore i am submitting another complaint in regards to these lenses as well.) product information: 2 boxes of hubble soft hydrophilic daily wear lenses, -5.25, bc: 8.6, dia: 14.2, lot: 619183, exp: 8/2024, bar code: (b)(4).Fda safety report id #: (b)(4).

• Brand Name: SOFT HYDROPHILIC CONTACT LENS FOR DAILY WEAR
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): HUBBLE/ST. SHINE OPTICAL CO., LTD.
• MDR Report Key: 9986668
• MDR Text Key: 188970602
• Report Number: MW5094214
• 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: 04/18/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/01/2024
• Device Lot Number: 619183
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 77