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

Lot Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Corneal Ulcer (1796)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

The lot number is unknown and the products are not made available for evaluation at this time.Our distributor emailed to the initial reporter to obtain the additional information, however, there's no response.If the additional information is received, the follow-up report will be submitted within 30 days of the receipt.Subsequent actions regarding the follow-up report will be taken and submitted in accordance with 21 cfr 803.10 and 803.56.

Event Description

The following information was obtained through medwatch report.Report number: mw5076801.The event description was: "corneal ulcer from hubble contact lenses that were purchased without prescription.".

• Brand Name: HUBBLE
• Type of Device: SOFT CONTACT LENS
• Manufacturer (Section D): ST. SHINE OPTICAL CO., LTD.; 4,5 f/l no. 276-2 sec. 1; tatung rd., hsi chih dist.,; new taipei city, 221 ; TW 221
• Manufacturer Contact: jeremy lin ; 4,5 f/l no. 276-2 sec. 1; tatung rd., hsi chih dist.,; new taipei city, 221 ; TW 221
• MDR Report Key: 7581517
• MDR Text Key: 110464085
• Report Number: 9617499-2018-00008
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other