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

Lot Number B00GHRM

Device Problem Disposable (1185)

Patient Problems Corneal Ulcer (1796); Unspecified Infection (1930); Keratitis (1944)

Event Date 02/27/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, a patient (pt) reported having experienced recurrent ocular issues od which included a corneal ulcer (cu) while wearing acuvue oasys contact lenses (cl).The pt stated he/she was wearing cl on daily wear and biweekly replacement schedule and using opti-free lens care solution.The pt had worn oasys lenses for about 5 years and started experiencing recurrent issues with a carton from the most recent supply.On (b)(6), our firm spoke with the treating doctor's office who stated they saw the pt for the first time on (b)(6) 2014.He/she was dx with keratitis od and treated with tobradex drops q3hrs and instructed not to wear cl for 2 weeks.On (b)(6) 2014, pt returned feeling much better and was instructed to d/c tobradex and use artificial tears; no cl for 2 weeks.On (b)(6) 2014, pt returned c/o od problem recurred, sle revealed cu at 09:30; the treatment regimen included vigamox q3hrs x1 week and no cl use.On (b)(6) 2014, fu corneal scar at 0900, use artificial tears and no cl x1 month.On (b)(6) 2014, pt returned c/o pain and light sensitivity and was dx recurring cu and instructed to use tobradex q2hrs x1 day then q4x1 week.On (b)(6) 2014, f/u cornea clear, no cl 2 wks, d/c tobradex.Pt was given trials of competitive brand.

Manufacturer Narrative

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.No additional information is expected.Mdr reportable event trends are reviewed in quarterly management review meetings.If additional information is received, will report within 30 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: 3893614
• MDR Text Key: 20460651
• Report Number: 1033553-2014-00045
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2018
• Device Lot Number: B00GHRM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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
• Treatment: OPTI FREE
• Patient Age: 22 YR