MAUDE Adverse Event Report: VISTAKON / JOHNSON & JOHNSON ACUVUE OASYS; SOFT CONTACT LENS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Neovascularization (1978)

Event Date 01/18/2014

Event Type  Injury  

Event Description

Corneal neovascularization due to contact lens abuse.The pt had been over wearing the contact lenses each day.The pt had been wearing a two week lens for at least one month.The pt had been purchasing boxes of the contact lenses from (b)(6) without a current contact lens prescription.

• Brand Name: ACUVUE OASYS
• Type of Device: SOFT CONTACT LENS
• Manufacturer (Section D): VISTAKON / JOHNSON & JOHNSON
• MDR Report Key: 3600258
• MDR Text Key: 4167396
• Report Number: MW5034082
• Device Sequence Number: 1
• Product Code: LPM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR