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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Corneal Ulcer (1796); Irritation (1941); Red Eye(s) (2038)

Event Date 07/20/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 a patient (pt) reported corneal ulcers ou while wearing acuvue oasys contact lenses (cl).The patient used opti-free pure moist lens care solution and wore and lenses on a daily wear and monthly replacement schedule.The patient reported that he/she "always wore acuvue oasys contact lenses and one month ago wore the first pair of a new carton for two weeks feeling discomfort in some of the days." the patient wore the second pair and after two weeks of use both eyes were very red and irritated.The patient saw a doctor and was diagnosed with corneal ulcers ou, no meds were prescribed.The patient was advised to use acrylic contact lenses instead of soft contact lenses.The following day the patient was seen by another ecp at the hospital where the patient worked who confirmed corneal ulcers ou and prescribed epitegel 5x/day and hylogel drops 5x/day."corneal ulcer" may or may not be a serious injury.Based on the limited information received, and extended treatment time, this injury will be reported as a serious injury as a worst case.

Manufacturer Narrative

A dhr was not performed because the lot number was not available and a product evaluation could not be performed because the product was discarded.Mdr 1033553-2014-00079 for other eye.Our firm has not been able to obtain additional medical information; if additional information is received it will report within 30 days of receipt.Mdr reportable event trends are reviewed in quarterly franchise management review meetings.Device not returned.No evaluation will be performed.No conclusions can be drawn.

• 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: 4106659
• MDR Text Key: 16447635
• Report Number: 1033553-2014-00078
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 09/11/2014

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: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/20/2014
• Initial Date FDA Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OPTI-FREE LENS CARE SOLUTION
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 30 YR