MAUDE Adverse Event Report: VISTAKON ACUVUE2 COLOURS BRANDS CONTACT LENSES; SOFT CONTACT LENS, DISPOSABLE

Device Problem Disposable (1185)

Patient Problem Loss of Vision (2139)

Event Type  Injury  

Event Description

A pt contacted our firm stating his left cornea was "cut" while wearing acuvue colours brand contact lenses.He states he has lost the vision of that eye.He would not provide info regarding his injury or treatment.He referred all questions to his attorney.Spoke with the attorney.The pt has not provided the attorney with medical records or other info.As the pt did not provide medical or product info, this is being reported as worst case.If add'l info is rec'd, will report within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

Manufacturer Narrative

Device labeling single use or reuse.No eval will be performed.No conclusions can be drawn.

• Brand Name: ACUVUE2 COLOURS BRANDS CONTACT LENSES
• Type of Device: SOFT CONTACT LENS, DISPOSABLE
• Manufacturer (Section D): VISTAKON; jacksonville FL
• Manufacturer Contact: rose harrell ; p.o. box 10157; jacksonville, FL 32247
• MDR Report Key: 3581164
• MDR Text Key: 4162014
• Report Number: 1033553-2014-00004
• 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: Other,Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• 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
• Date Manufacturer Received: 12/17/2013
• 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): Disability
• Patient Age: 55 YR