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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Corneal Ulcer (1796); Irritation (1941)

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient (pt) stated that last year (date unknown) she experienced a left eye (os) corneal ulcer while wearing acuvue oasys contact lenses.Pt stated she was experiencing irritation, went to see her eye care professional (ecp) and was told she had a corneal ulcer.Pt stated that she was given antibiotic drops, q1h for 2 days and then tapered off for a week.Pt saw the ecp twice and was cleared to return to lenses after a week of treatment.Pt stated that the ulcer did not affect her va at any time.Pt did not want to provide further event or ecp information.No additional information is available at this time.A corneal ulcer may or may not be serious injury.However, the event is being reported as a worst case due to the aggressiveness in treatment.

Manufacturer Narrative

The product was not returned and no lot number is available.Therefore, the complaint cannot be confirmed and no device history review can be conducted.Based on all available information, no causal factors can be determined and no conclusion can be drawn.Additional information will be submitted within 30 days of receipt.Mdr reportable event trends are reviewed quarterly in franchise management review meetings.Labeling stated device is approved for single use or reuse.

• Brand Name: ACUVUE OASYS BRAND CONTACT LENSES
• Type of Device: SOFT CONTACT LENS
• Manufacturer (Section D): VISTAKON; jacksonville FL
• Manufacturer Contact: rose harrell ; p.o. box 10157; jacksonville, FL 32247 ; 9044433647
• MDR Report Key: 3682616
• MDR Text Key: 21313254
• Report Number: 1033553-2014-00025
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/07/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/18/2014
• Initial Date FDA Received: 02/27/2014
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention