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

Lot Number L0023FN

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

Patient Problems Conjunctivitis (1784); Corneal Ulcer (1796); Itching Sensation (1943); Red Eye(s) (2038); Virus (2136); Fungal Infection (2419)

Event Date 12/01/2013

Event Type  Injury  

Manufacturer Narrative

Device labeling single use or reuse.No evaluation will be performed.

Event Description

On (b)(6) 2013, a patient (pt) notified our (b)(6) affiliate reporting an ocular event ou while wearing acuvue oasys contact lenses; os worse than od.The pt was using renu lens care solution, the replacement schedule is unknown.On (b)(6) 2013 - pt experienced itching.On (b)(6) 2013 - pt was seen in urgent care and dx with viral conjunctivitis and treated with zypred, the dose and frequency are unknown.On (b)(6) 2013 - pt wore a second pair of lenses from the same carton, experienced itching, was dx with viral conjunctivitis and treated again.On (b)(6) 2014 - eyes remained irritated and the pt saw a second ecp who treated her with zylet, the dose and frequency are unknown; tests were performed.The pt returned to the clinic on (b)(6) 2014 and was instructed to use amphotericin every 2 hrs x10 days and fluconazole once a week x2 doses.On (b)(6) 2013, the pt saw a third ecp because she had red eye; it is unknown if one or both eyes were red.The ecp agreed with treatment from the previous doctor.After receiving results of the test(s) performed the doctor agreed with the medication treatment prescribed; the doctor also instilled unknown "eye drops," the redness decreased but the eye remained swollen.It is unknown if the pt experienced fungal keratitis or a fungal ulcer.Based on the information provided this event is reported as worst case.Os reported in 1033553-2014-00019.A device history review was performed.The batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.If additional information is received, will report within 30 days of receipt.Mdr reportable event trends are reviewed in quarterly management review meetings.

• Brand Name: ACUVUE OASYS BRAND
• Type of Device: DISPOSABLE SOFT CONTACT LENS
• Manufacturer (Section D): VISTAKON; limerick ; EI
• Manufacturer Contact: rose harrell ; p.o. box 10157; jacksonville, FL 32247 ; 9044433647
• MDR Report Key: 3677148
• MDR Text Key: 18711615
• Report Number: 1033553-2014-00018
• 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: Foreign,Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/19/2014

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
• Device Expiration Date: 04/01/2018
• Device Lot Number: L0023FN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/23/2014
• Initial Date FDA Received: 02/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RENU LENS CARE SOLUTION
• Patient Outcome(s): Other; Required Intervention