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

Device Problem Fitting Problem (2183)

Patient Problems Corneal Abrasion (1789); Visual Disturbances (2140)

Event Date 05/06/2019

Event Type  Injury  

Event Description

Pt ordered hubble contact lenses from (b)(6).Hubble never sent any communication to my office (this is one of several occurrences which is prompting me to write to the fda) for verification.The pt suffered corneal damage and vision changes due to poorly fitting contact lenses.This company is subverting the law, putting pts at risk, and blatantly doing so.The avarice and arrogance exhibited by this company is unprecedented in the contact lens industry.I only hope enough complaints are recorded so the government can put a stop to this.Fda safety report id# (b)(4).

• Brand Name: HUBBLE CONTACT LENSES
• Type of Device: LENSES, SOFT, CONTACT, DAILY WEAR
• Manufacturer (Section D): HUBBLE / ST. SHINE OPTICAL CO., LTD.
• MDR Report Key: 8596729
• MDR Text Key: 144706423
• Report Number: MW5086491
• 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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2019
• 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: 36 YR
• Patient Weight: 98