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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Corneal Ulcer (1796); Dry Eye(s) (1814)

Event Date 01/01/2010

Event Type  Injury  

Event Description

On (b)(6) 2014, a pt (pt) contacted our affiliate and reported a diagnosis of corneal ulcer in both eyes because of severe dryness while wearing 1-day acuvue moist contact lenses in "january or february about 4 years ago." this report is fort the left eye."it is reported that the pt had a history of dry eye.The pt was instructed to discontinue contact lens (cl) wear for about 2 weeks.The pt was prescribed eye drops.After that, the pt was recommended to use 1-day trueye lenses and wore the cls without issue.It is reported that the pt's ou is fine at the moment.The pt refused a medical interview.The pt did not remember further info regarding the symptoms ou after removal of the suspect cl, name of the treating eye care professional (ecp), consult date, the ecp's instructions for follow-up visit, or the name of the prescription eye drops" no additional info is expected from the pt.Info for the right eye is documented in mdr 1033553-2014-00063.

Manufacturer Narrative

The product was not returned for evaluation.The lot number for the device is unk, therefore a device history report review could not be conducted and the parameters of the lens could not be measured.No causal factors can be determined and no conclusion can be drawn.Any additional info received will be reported within 30 days of receipt.Mdr reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: 1-DAY ACUVUE MOIST 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: 4024489
• MDR Text Key: 4884142
• Report Number: 1033553-2014-00064
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 07/09/2041
• Initial Date FDA Received: 08/01/2014
• 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