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 06/24/2014

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.Note: the ecp instructed the pt to use new solution and lens case after first event.Third event: the pt was seen for an emergency exam on (b)(6) 2014.Pt complained of pain and blurry vision ou (pt has new spectacle rx).Quality: unchanged; severity: 8 (10 being worst); duration: constant; modifying factors: wears contacts wears glasses, signs/ symptoms: squint.Dva od: 20/25.The ecp noted a new corneal ulcer at 3 o'clock od.The ecp noted old ulcers healed, but still residual scar.Diagnosis per icd-9-cm 370.01: corneal ulcer, marginal.Treatment: ciprofloxan 0.3 percent, 1 drop qid.(b)(6) 2014: pt rtc for follow-up pt's chief complaint (cc): blurry vision.Signs and symptoms: squint.Severity 8.Dva od: 20/20.The ecp noted the corneal ulcer od was 98 percent healed.Plan: cipro qid od for 2 days, then sue proclear 1 day ou with drop before insertion and after removal.Rtc 7- 10 days.(b)(6) 2014 spoke with ecp, he said the pt rtc on (b)(6) 2014.The corneal ulcer was 100 percent resolved.The pt had been switched to alcon dailies contact lenses.The pt was instructed to use cipro 0.3 percent 1 drop qd prior to cl insertion.The cpt said this event was determined to be an infectious corneal ulcer due to the presentation of redness and pain and in his opinion the injury did not look like a non-infectious corneal ulcer.No additional information expected for this event.The other two events associated with this pt are documented in mdrs 1033553-2014-00055 and 1033553-2014-00056.

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: 4012863
• MDR Text Key: 4688636
• Report Number: 1033553-2014-00057
• 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,Health Professional,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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: OPTIFREE MULTIPURPOSE SOLUTION
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR