MAUDE Adverse Event Report: LIMERICK IRELAND ACUVUE OASYS BRAND W/ HYDRACLEAR; DISPOSABLE SOFT CONTACT LENS

Lot Number L002593

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Pain (1994); Red Eye(s) (2038)

Event Date 04/19/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 our brazil affiliate received a call from a pt reporting having experienced an ocular event while wearing acuvue oasys contact lenses (cl).The pt was wearing the lense on a daily wear and monthly replacement schedule and using renu lens care solution.The pt reported having worn oasys lenses since 2012 and only wore a lens in the od.She wore the first two lenses from the involved box with no issues and the third one she wore for a day and experienced redness and discomfort.The pt was seen by a doctor on (b)(6) 2014, dx with an unk infection and treated with tobradex 2 drops q3hrs.The pt was instructed to return to clinic the following monday.On (b)(6) 2014 the pt reported that the doctor postponed her appointment until (b)(6) 2014 due to holiday and stated her eye was "perfect" and that she resumed lens wear on (b)(6) 2014.The pt did not have the treating clinic's contact info but provided the names of the clinic and treating doctor.Our affiliate performed a "google search" locating the clinic's contact info.Our medical affairs department contacted the clinic was told by staff that they did know the doctor mentioned and found no record of the pt.The pt experienced and unk "infection" and received aggressive treatment.Due to the limited amount of info this event is submitted as worst case.The suspect product was not available.A dhr was performed; l002593 was produced under normal mfg conditions.The batch record did not show abnormalities in monomer and solution testing.All parameters tested were within specification and sterilization requirements were successfully completed.Additional info will be reported within 30 days or receipt.Mdr reportable event trends are reviewed in quarterly franchise management review meetings.

• Brand Name: ACUVUE OASYS BRAND W/ HYDRACLEAR
• Type of Device: DISPOSABLE SOFT CONTACT LENS
• Manufacturer (Section D): LIMERICK IRELAND
• Manufacturer Contact: rose harrell ; po box 10157; jacksonville, FL 32247 ; 9044433647
• MDR Report Key: 3839253
• MDR Text Key: 4412899
• Report Number: 1033553-2014-00041
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/20/2014

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: 07/01/2018
• Device Lot Number: L002593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2014
• Initial Date FDA Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RENU LENS CARE SOLUTION
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR