MAUDE Adverse Event Report: VISTAKON ACUVUE OASYS BRAND; DISPOSABLE SOFT CONTACT LENS

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Iritis (1940); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137)

Event Date 02/06/2014

Event Type  Injury  

Event Description

While reviewing a clinic notes received on (b)(6) 2014 for an adverse event os, another ulcer was discovered for the other eye.The notes indicated the following: (b)(6) 2014, patient (pt) presented to the doctor's office reporting having been told by another eye doctor that she had an ulcer os.She was treated with zylet and atropine and use the drops once.She wanted a second opinion and was seen by the reporting doctor.The pt reported that she normally did not sleep in lenses but she "did sleep in them 2 nights in a row because of no electricity".The pt reported a history of irritation and pain ou (os>od) that started on (b)(6) 2014 and having removed the lenses early in the evening because her eyes were hurting, tearing and photophobic.Sle revealed conjunctiva white and quiet ou.Corneal edema ou; corneal ulcer ou and corneal opacity ou.The pt was treated with zylet 1 drop qhr x2 days, then q2hrs x3 days and instructed to return in one event.Va 20/20; (b)(6) 2014, pt returned "os 1 week f/u cu".She stated her od was bothering her now and complained of itching ou.Sle revealed conjunctiva white and quiet ou, ac deep and quiet ou; dx with cu ou.Pt treated with vigamox drops bid until complete them zylet daily until sample complete.Va 20/20.Administration of antibiotic drops qhr is considered to be aggressive medical treatment; this event is reported as worst case.

Manufacturer Narrative

The product in question and lot number were not available.If add'l info is received, will report within 10 days of receipt.Mdr reportable event trends are reviewed quarterly in executive management review meetings.

• Brand Name: ACUVUE OASYS BRAND
• Type of Device: DISPOSABLE SOFT CONTACT LENS
• Manufacturer (Section D): VISTAKON; jacksonville FL
• Manufacturer Contact: rose harrell ; po box 10157; jacksonville, FL 32247 ; 9044433647
• MDR Report Key: 3732941
• MDR Text Key: 4306920
• Report Number: 1033553-2014-00031
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: P040045
• 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: 03/25/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2014
• Initial Date FDA Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 44 YR