MAUDE Adverse Event Report: VISTAKON 1-DAY ACUVUE TRUEYE BRAND CONTACT LENSES; SOFT CONTACT LENS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Corneal Scar (1793)

Event Date 06/01/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 a pt called our firm to report that he/she had "staining and dot in the black part of os due to 1day trueye lens.The pt was seen at an eye clinic.The pt was told that the staining was quite deep.The pt recovered about two months later.The pt was told that the staining would leave a slight scar.The pt was instructed to discontinue contact lens (cl) wear.The pt could not wear cl for about two months (it is unk how long the pt was instructed to discontinue cl wear).The pt was given prescription medications.The pt's os is fine and the pt wears cls at the moment." on (b)(6)2014, our firm contacted the cl sales shop associated with the eye clinic, and obtained the following information."the pt was seen at the eye clinic on (b)(6) 2014; at that time, the pt was fitted with 1day trueye lenses and did not get a prescription for cls." on (b)(6)2014, our firm contacted the eye clinic and obtained the following information."the pt was seen at the clinic initially in (b)(6) 2014 and five times in total.The sys care professional (ecp) gave the pt a prescription for eye drops.".

Manufacturer Narrative

On (b)(6) 2014, the pt refused to allow our firm to contact the eye clinic for a medical interview.The suspect lens was discarded.The lot number is unk so no product investigation can be completed.Due to the limited information provided by the pt, this os event is being reported as a worst case.If additional information is received it will be reported within 30 days of receipt.Serious reportable event rends are reviewed quarterly in executive management review meetings.

• Brand Name: 1-DAY ACUVUE TRUEYE BRAND CONTACT LENSES
• Type of Device: SOFT CONTACT LENS
• Manufacturer (Section D): VISTAKON; jacksonville FL
• Manufacturer Contact: rose harrell ; po box 10157; jacksonville, FL 32247 ; 9044433647
• MDR Report Key: 4257409
• MDR Text Key: 5018550
• Report Number: 1033553-2014-00102
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K073485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/14/2014

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: 10/24/2014
• Initial Date FDA Received: 11/14/2014
• 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): Required Intervention
• Patient Age: 39 YR