MAUDE Adverse Event Report: VISTAKON ACUVUE ADVANCE PLUS BRAND CONTACT LENS; SOFT CONTACT LENS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Corneal Ulcer (1796); Unspecified Infection (1930); Red Eye(s) (2038)

Event Date 04/28/2014

Event Type  Injury  

Event Description

Sales rep requested we call an eye care professional ecp).Called ecp, he said a (b)(6)patient (pt) developed 3 peripheral corneal ulcers while wearing acuvue advance plus brand contact lenses.The corneal ulcers were all in the right eye (od), mid-peripheral and at different locations on the cornea.The ecp said he suspected these were infectious corneal ulcers.First event: the pt was seen for an emergency exam on (b)(6) 2014.Pt complained of red, watery od for 3 days.Quality: moderate, worsening; severity: 6 (10 being worst); duration: constant; modifying factors: contact lenses; signs/symptoms: watery, discomfort.Dva od: 20/20.The ecp noted a corneal ulcer at 2 o'clock od.Diagnosis per icd-9-cm 370.01: marginal corneal ulcer.The pt was treat with ciprofloxan 0.3 percent, 1 drop qid.The pt returned to clinic (rtc) on (b)(6) 2014.Pt's chief complaint (cc): red eye (od).Dva od: 20/20.The ecp noted the corneal ulcer od was 60 percent to 70 percent healed.Treatment: cipro qid od and rtc for follow-up.The pt rtc on (b)(6) 2014.Cc: red eye.Quality: improving; severity 2; duration: limited; onset: 1 week; modifying factors: contact lenses, drops; signs/symptoms: none.Dva on 20/20.Impression: corneal ulcer 2 o'clock od 99 percent healed.Treatment: cipro for 3 days, then wait one week for cl wear.The ecp said this event was determined to be an infectious corneal ulcer due to the presentation of redness and pains and in his opinion the injury did not look like a non-infectious corneal ulcer.No additional information is expected for this event.The other two events associated with this pt are document in mdrs 1033533-2014-00056 and 1033553-2014-00057.

Manufacturer Narrative

The product and lot number were requested.The ecp said the product had been discarded.A lot number from a sealed multipack from the same order was available, but it is not known if the lot number was the same as the suspect lens.That lot number is b00grzv.The expiration date is january 11, 2019.The device manufacturing date is february 11, 2013.A dhr review was performed: 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.There are no other complaints for this lot.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 trends are reviewed quarterly in franchise management review meetings.

• Brand Name: ACUVUE ADVANCE PLUS BRAND CONTACT LENS
• Type of Device: SOFT CONTACT LENS
• Manufacturer (Section D): VISTAKON; jacksonville FL
• Manufacturer Contact: rose harrell ; po box 10157; jacksonville, FL 32247 ; 9044433647
• MDR Report Key: 4012888
• MDR Text Key: 15180280
• Report Number: 1033553-2014-00055
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032340
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/21/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2014
• Initial Date FDA Received: 07/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: OPTIFREE MULTIPURPOSE SOLUTION
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 15 YR