MAUDE Adverse Event Report: CIBA VISION CORPORATION DES PLAINES FRESHLOOK COLORS; LENSES, SOFT CONTACTS, EXTENDED WEAR

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796); Unspecified Infection (1930); Fungal Infection (2419)

Event Type  Injury  

Manufacturer Narrative

The complaint product was not returned for eval at this time.The device history record and sterilization record and investigation for this lot are in progress.Upon completion of the investigation, a follow-up medwatch will be filed.(b)(4).

Event Description

This is the third of three reports from the same reporter involving three pts diagnosed with infectious corneal ulcers.Two of the pts have bacterial corneal ulcers and one of the pts has a fungal corneal ulcer.It is unk which diagnosis is for which pt.This report is representative of the unspecified pts: refer to 1422160-2014-00018 for the description of the initial report which is representative of the known pt.Refer to 14422160-2014-00019 for the description of the second report which is representative of the unspecified pt.On (b)(6) 2014, an eye care professional (ecp) reported that he had two pts with severe infectious bacterial corneal ulcers in their eyes and one pt with an infectious fungal corneal ulcer.The ecp then reported that two of the pts would likely lose sight permanently in their eyes.He reported that the pt purchased freshlook contacts from their local shell or exxon service stations.He also reported that he called the stations who told him that they are sent contact lenses directly from the mfr.As of (b)(6) 2014, the ecp reported that he prescribed besivance ointment four times daily for the pts with the bacterial corneal ulcers.He then reported that the one of the pts was storing the contact lenses in tap water and wearing them on and off for three months.Additional info was requesting but not yet received.

• Brand Name: FRESHLOOK COLORS
• Type of Device: LENSES, SOFT CONTACTS, EXTENDED WEAR
• Manufacturer (Section D): CIBA VISION CORPORATION DES PLAINES; des plaines IL
• Manufacturer Contact: bryan blake ; 11460 johns creek parkway; johns creek, GA 30097 ; 6784153131
• MDR Report Key: 4039987
• MDR Text Key: 16941190
• Report Number: 1422160-2014-00020
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention