MAUDE Adverse Event Report: JOHNSON AND JOHNSON VISION CARE, INC ACUVUE ADVANCE BRAND CONTACT LENS; SOFT CONTACT LENS

Lot Number B00G1Q4

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Bacterial Infection (1735); Irritation (1941); Keratitis (1944)

Event Date 10/11/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 our firm received a call from a pt who was diagnosed with an eye infection ou one month ago while wearing an acuvue advance contact lens.The pt advised that both eyes were irritated after two days of contact lens (cl) use.The pt advised that the suspect contact lenses were removed and after a few days the pt wore the same pair of lenses and again the pt experienced irritation ou.The pt noted that it was worse in the os.The event occurred on (b)(6) 2014.The pt advised that he/she went to an eye care professional (ecp) after two days and the ecp diagnosed an infection in both eyes (ou) and prescribed two eye drops and a pomade for 10 days.The pt returned to the ecp and was prescribed two eye drops for os for one week.After the last treatment the pt returned to the ecp and the ecp identified a change in the power of left eye (os) and authorized the use of contact lenses after one month.On (b)(6) 2014 the pt sent an e-mail with add'l info.The pt states that he/she was initially was prescribed besivance eye drop to be used every 6 hours with maxinom to be used before sleep.The medications were used in both eyes.After 3 days, the pt returned to the ecp and was prescribed flutinol to be used with the besivance eye drops.The pomade was continued and used before bedtime.On that date, the pt discontinued treatment for the od and treatment continued for the os.The pt states that he/she used the besivance, flutinol, and maxinom in the os only.After 7 days the pt returned to the ecp and maxinom was discontinued.The pt continued the use of besivance and flutinol eye drops for 1 additional week os.The pt returned to the ecp and the ecp prescribed systane eye drops to "use until the end of the medication, including using it while i wear the contact lenses.It is important to say that during this time i was not wearing contact lenses." on (b)(6) 2014, the ecp was contacted and add'l info was provided.It is reported that the pt presented "complaining of blurred vision on his/her os and irritation.Presenting bacterious keratitis with infiltrates; od without alterations.Have a good evolution with besivance and maxinom ointment.And after 7 days, maxinom was stopped and initiated flutinol for 10 days.During this period the pt was oriented not to wear contact lenses.The pt was released using lubricant eye drops, without permanent damages." the product was requested for eval, but has not yet been received.A lot history review was performed and revealed the batch did not show any abnormalities in monomer nad solution testing.All parameters tested were within spec.All sterilization requirements were successfully completed.This report is to capture the os event.The od event is being captured as 1033553-2014-00108.

Manufacturer Narrative

One lens case and 2 sealed blisters were returned.The parameters of two lenses were measured and a visual inspection was performed.The lenses meet company standards for base curve, center thickness, and diameter.The solution was also tested; the ph was in specification; there was not enough solution to measure conductivity.One contact lens was torn and the parameters could not be measured.No other visual attributes were observed.(b)(4).

• Brand Name: ACUVUE ADVANCE BRAND CONTACT LENS
• Type of Device: SOFT CONTACT LENS
• Manufacturer (Section D): JOHNSON AND JOHNSON VISION CARE, INC; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 4294611
• MDR Text Key: 5052774
• Report Number: 1033553-2014-00109
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K032340
• 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,Followup
• Report Date: 03/30/2015

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: 05/01/2019
• Device Lot Number: B00G1Q4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2015
• Initial Date Manufacturer Received: 03/30/2015
• Initial Date FDA Received: 11/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• 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: RENU MULTIPURPOSE SOLUTION
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR