MAUDE Adverse Event Report: LIMERICK IRELAND ACUVUE OASYS BRAND W/HYDRACLEAR; SOFT CONTACT LENS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Corneal Ulcer (1796); Unspecified Infection (1930); Irritation (1941)

Event Date 06/25/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 our affiliate was informed of a patient (pt) who experienced a corneal ulcer (cu) os while wearing acuvue oasys contact lenses (cl).The pt wore the lenses as extended wear and replaced them every 2-4 weeks; the lens care solution is unknown.The pt was changing contact lenses and experienced irritation and noted a white spot on the cornea.The report stated the "patient went to the optic to change her contact lenses (contact lenses are changed in their contactology cabinet every two weeks), and expressed she had an eye a little irritated and a whitish spot on cornea".The doctor felt it "was a fungal infection or bactariana" and referred the pt.To an ophthalmologist.The pt was dx with a central corneal ulcer located on the "upper half of the cornea".The pt was instructed not to wear cl for a month and not to sleep in cl when allowed to resume lens wear.

Manufacturer Narrative

The lot number and product in question were not available.Additional information will be reported within 30 days of receipt.Mdr reportable event trends are reviewed quarterly in franchise executive management review meetings.

• Brand Name: ACUVUE OASYS BRAND W/HYDRACLEAR
• Type of Device: SOFT CONTACT LENS
• Manufacturer (Section D): LIMERICK IRELAND; jacksonville FL
• Manufacturer Contact: rose harrel ; po box 10157; jacksonville, FL 32216 ; 9044433647
• MDR Report Key: 4009515
• MDR Text Key: 4778836
• Report Number: 1033553-2014-00053
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2014

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/26/2014
• Initial Date FDA Received: 07/16/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR