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

Lot Number UNKNOWN

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

Patient Problems Corneal Ulcer (1796); Irritation (1941); Keratitis (1944); Blurred Vision (2137)

Event Date 05/17/2018

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: mw5077450.The event description was: "the patient is a long-time contact lens wearer.She started wearing a hubble contact lenses a few months ago and her vision gradually became blurrier and blurrier, and her eyes have been very irritated.Refraction revealed a -1.75 diopter shift in her vision in each eye.Slit lamp examination revealed a corneal ulcer of the right eye and significant punctate keratopathy in the left eye.This is my fifth patient who has presented for an exam with hubble contact lenses, and she is the fourth who has had a corneal ulcer or significant contact-lens-related corneal problem.I have heard similar reports from other eye care practitioners.I am concerned that this brand of contact lenses is contributing to these potentially sight-threatening corneal issues.I am also concerned that the hubble contact lens company does not properly verify patient contact lens prescriptions.".

• 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: 7665702
• MDR Text Key: 113282260
• Report Number: 9617499-2018-00010
• 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: 07/06/2018
• 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
• Date Manufacturer Received: 06/06/2018
• 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