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

Lot Number B00DG87

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

Patient Problems Acanthameba Keratitis (1945); Loss of Vision (2139)

Event Date 09/27/2013

Event Type  Injury  

Event Description

On (b)(6) 2013, our firm received an email from a patient's (pt) spouse reporting the pt experienced acanthamoeba keratitis ou while wearing acuvue oasys contact lenses (cl) and was being considered for corneal transplant in one or both eyes.The pt wore the lenses on a daily wear schedule, the replacement schedule was not reported.Mdr number 1033553-2014-00003 submitted for the os.On (b)(6) 2013, we spoke with the pt's spouse who stated the pt was seen by a doctor for the first time on (b)(6) 2013 and dx with acanthamoeba on (b)(6) 2013.He stated the pt didn't "have vision in either eye." cultures of both eyes were performed, testing positive for acanthamoeba.The pt's spouse stated they were in florida when the symptoms occurred and that the pt had been in a pool but her head wasn't submerged in the water.He also stated that the pt had showered while wearing cl.On (b)(6) 2014 the ecp's stated the pt was in surgery but no details were provided.On (b)(6) 2014 the pt's husband stated the pt received a corneal transplant os on (b)(6) 2014; the od is not scheduled for a transplant at this time.Medical records were received on (b)(6) 2014.Additional information will be submitted within 30 days of receipt.Sixteen sealed blister were returned.The parameters were measured and a visual inspection was performed.The lenses meet company standards for base curve, center thickness and diameter.No other visual attributes were observed.The solution was also tested.The ph and conductivity were in specification.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.

Manufacturer Narrative

Device labeling single use or reuse.

• Brand Name: ACUVUE OASYS BRAND
• Type of Device: DISPOSABLE SOFT CONTACT LENS
• Manufacturer (Section D): VISTAKON; jacksonville FL
• Manufacturer Contact: rose harrell ; p.o. box 10157; jacksonville, FL 32247 ; 9044433647
• MDR Report Key: 3631893
• MDR Text Key: 4180858
• Report Number: 1033553-2014-00002
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/10/2014

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: 07/01/2017
• Device Lot Number: B00DG87
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/06/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2013
• Initial Date FDA Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CLEAR CARE
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 30 YR