MAUDE Adverse Event Report: VISTAKON ACUVUE OASYS FOR ASTIGMATISM CONTACT LENSES; SOFT CONTACT LENS

Lot Number B00FV68

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Corneal Ulcer (1796); Dry Eye(s) (1814); Irritation (1941); Neovascularization (1978)

Event Date 06/10/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 our affiliate was contacted by an eye care professional's (ecp) office to report an adverse event.The pt switched to acuvue oasys for astigmatism contact lenses (aofa) due to astigmatism in (b)(6) 2012.The pt wore the cls on a daily wear schedule, replacing the lenses every 2 weeks.The ecp reported that the aofa lenses fit "slightly tight." prior to that the patient (pt) had been successfully wearing daily disposable, spherical contact lenses (cl).The pt had a history of overwearing cls on occasion and a history of neovascularization.Sometime in (b)(6), the patient was reportedly wearing the cls 10 to 12 hours a day and the left eye (os) was reported to be uncomfortable.The pt changed lenses on 2 occasions due to discomfort, deposits and the lenses "feeling gritty." the pt wore glasses for "a couple of days" and then tried a fresh pair of lenses and experienced irritation with those lenses.The ecp said it was about a month from the onset until the pt was seen by the ecp on (b)(6) 2014.The pt was diagnosed with a peripheral corneal ulcer, os, located at 7 o'clock.The pt was referred to a hospital for treatment and was prescribed ciprofloxacin drops.On (b)(6) 2014 the ecp reported the pt was fine at that time and there was no reduction in visual acuity.The ecp believes the pt is continuing to wear cls "although they were uncomfortable and really shouldn't have." "she had very dry eyes and is going through menopause and she did overwear the lenses." additional information has been requested by not received.A dhr was performed and revealed the following information: a lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot b00fv68 was produced under normal conditions.Product has been requested for evaluation but has not been received at this time.Based on all available information, no causal factors can be determined and no conclusion can be drawn.If additional product or medical information is received, will report within 30 days of receipt.Mdr reportable event rends are reviewed quarterly in franchise management review meetings.

Manufacturer Narrative

Device not returned.No evaluation will be performed.Device labeling: single use or reuse.

• Brand Name: ACUVUE OASYS FOR ASTIGMATISM 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: 3975371
• MDR Text Key: 4886677
• Report Number: 1033553-2014-00049
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2018
• Device Lot Number: B00FV68
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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
• Treatment: SYNERGY BY SAUFLON
• Patient Outcome(s): Other; Required Intervention