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

Lot Number UNKNOWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Conjunctivitis (1784); Irritation (1941)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

The lot number is unknown and the products are not made available for evaluation at this time.The information about patient and initial reporter as well as other information required to submit was not provided.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: mw5084020.The event description was: "patient has been using hubble daily contact lenses for the past several months.He came in today to my office complaining of irritation with and without the contact lenses being on.Even if he has given his eyes a "break" by wearing glasses.His eyes have giant papillary conjunctivitis from these contact lenses and now required treatment.Therapy duration: 7 months.Diagnosis or reason for use: contact lenses, used to see.".

• 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: 8476577
• MDR Text Key: 140731485
• Report Number: 9617499-2019-00005
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K121201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• 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
• Date Manufacturer Received: 03/05/2019
• 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