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 Stromal Edema (1824); Hypoxia (1918); Keratitis (1944); Red Eye(s) (2038); Discharge (2225); Clouding, Central Corneal (2228); Corneal Infiltrates (2231); Discomfort (2330)

Event Date 08/26/2019

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 additional information provided.If the additional information is received, the follow-up report will be submitted within 30 days of the receipt.

Event Description

The following information was obtained when searching the maude database on (b)(4) 2019.Report number: (b)(4).The event description was: "pt wearing hubble contact lenses.Reported "stinging" sensation.Took lens out, left eye became red, photophobic, mild discharge.Pt reported as an emergency to the eye clinic.Eye was hypoxic.Central cornea cloudy, mild q/o infiltrate with stromal edema.Epithelium had diffuse but mostly perilimbal superficial punctate keratitis.Fda safety report id# (b)(4).".

• 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: 9165241
• MDR Text Key: 161731628
• Report Number: 9617499-2019-00013
• 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

• 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
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 10/08/2019
• 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; Required Intervention