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

Lot Number 5609800109

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Corneal Ulcer (1796); Pain (1994); Red Eye(s) (2038)

Event Date 07/22/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 our affiliate reported that a pt (pt) reported that he/she was off work with eye swelling, pain and redness os.The affiliate contacted the eye clinic for a med interview.On (b)(6) 2014, the ecp (eye care professional) states that the pt was seen at the clinic on (b)(6) 2014.The ecp advised that the pt's os was very red at the time of the initial visit.The pt advised the ecp that he/she developed pain os while wearing a misshaped cl (contact lens) and could not wear it because of pain."the ecp noted a deeply gouged staining, which was not so large and located at the edge of the peripheral part of the cornea os, about 1 o'clock.The pt was diagnosed with corneal ulcer os.The ecp is not sure whether the ulcer was infectious.The staining os was deeper than common staining caused by cl.The ecp wondered why such staining developed.

Manufacturer Narrative

The pt's va was not measured since it did not seem to be affected."the ulcer was located completely away from the pupil." the ecp thinks that the pt's va was probably not affected.The pt was treated with cravit 0.5% eye drops and tear balance 0.1% eye drops.The ecp noted sweeplike staining and corneal opacity os.On (b)(6) 2014, the pt was not instructed to return for follow-up.The pt was instructed to discontinue cl wear for another three days.The ecp determined that the pt would recover in three days.The pt still has corneal opacity os, which would take several years to resolve.The ecp determined that this event was cl-related because the pt stated that the pt had no symptom before this event occurred.The ecp determined that this event was not serious because the staining would resolve with the eye drops in about two weeks."corneal ulcer" may or may not be a serious injury.Tis event is being reported as worst case.A lot history review was performed and revealed the batch did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Two lens cases were received from the suspect lot # 5609600109 with one cl in each case.The lenses met company standards for base curve, ctr thickness, and diameter.Visual inspection revealed no abnormalities.Five additional sealed blisters from the same lot were returned for evaluation; the solution of those lenses was tested.The ph and conductivity were within specification.Any additional info received will be reported within 30 days of receipt.Mdr reportable event trends are reviewed in franchise mgmt review meetings.

• Brand Name: 1-DAY ACUVUE TRUEYE CONTACT LENS
• Type of Device: SOFT CONTACT LENS
• Manufacturer (Section D): VISTAKON; limerick ; EI
• Manufacturer Contact: rose harrell ; po box 10157; jacksonville, FL 32247 ; 9044433647
• MDR Report Key: 4101673
• MDR Text Key: 4703603
• Report Number: 1033553-2014-00069
• 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,Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/27/2014

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
• Device Expiration Date: 03/01/2018
• Device Lot Number: 5609800109
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/15/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/29/2014
• Initial Date FDA Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention