MAUDE Adverse Event Report: VISTAKON UNKNOWN, PRESUMED ACUVUE BRAND; SOFT CONTACT LENS, DISPOSABLE

Device Problems Material Disintegration (1177); Device Operates Differently Than Expected (2913)

Patient Problem Blurred Vision (2137)

Event Date 01/05/2014

Event Type  Injury  

Event Description

Early sunday morning, (b)(6) 2014, a patient called our security desk.The caller reported that she had an emergency, that a lens had "disintegrated" in her eye, that it was "stuck" to her eye and her "vision was impaired." the patient has not respond to multiple messages left on her voicemail.As we have been unable to confirm or follow up on the event, this is being reported as worst case.If additional information is received, will report within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

Manufacturer Narrative

Device not known.Conclusions: device not returned.No evaluation will be performed.No conclusions can be drawn.

• Brand Name: UNKNOWN, PRESUMED ACUVUE BRAND
• Type of Device: SOFT CONTACT LENS, DISPOSABLE
• Manufacturer (Section D): VISTAKON; jacksonville FL
• Manufacturer Contact: rose harrell ; p.o. box 10157; jacksonville, FL 32247 ; 9044433647
• MDR Report Key: 3644965
• MDR Text Key: 4352310
• Report Number: 1033553-2014-00011
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N18033
• 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: 01/31/2014

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2014
• Initial Date FDA Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other