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

Lot Number UNKNOWN

Device Problems Patient-Device Incompatibility (2682); Material Integrity Problem (2978)

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Date 02/09/2018

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 the other information required to submit were 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 when searching the maude database on mar.12, 2018.Report number: mw5075473.The event description was: "patient was dispensed a non prescribed, not approved contact lens by hubble contact lenses.The lens was not appropriate to the patient.The patient developed bilateral eye inflammation after just 1 week of wear.She also developed an infection.This was treated with antibiotics and steroids.Without interventions she could have developed corneal scarring and vision loss.Patient has been a long time successful contact lenses wearer and was caring for lenses properly.".

• 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: 7424046
• MDR Text Key: 105240474
• Report Number: 9617499-2018-00003
• 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: 04/11/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2018
• 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): Required Intervention