MAUDE Adverse Event Report: LIMERICK ACUVUE 2 BRAND; SOFT CONTACT LENS

Lot Number L0029G5

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Bacterial Infection (1735); Keratitis (1944); Pain (1994); Red Eye(s) (2038)

Event Date 08/01/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 a patient our firm via email reporting having experienced an ocular event ou while wearing acuvue 2 contact lens (cl).The pt reported "i started getting eye infections in mid (b)(6).After consulting a doctor numerous times, i took my antibiotics as needed and decided to stop wearing contacts all together, in early (b)(6).I decided to finally put fresh contacts (straight out of the box!) in my eye on friday afternoon.By friday night, my eyes were bright red and i couldn't even open them." the pt wen to urgent care three times and treated with "antibacterial prescriptions".The wear and replacement schedules are unk; the pt was using b&l lens care solution, name unk.Our firm spoke with the pt the same day who reported ocular issues in (b)(6) and he/she visited urgent care and was treated vigamox ou tid x 1wk.The issues recurred in (b)(6) and the pt was prescribed vigamox tid ou.The pt was told he/she restarted lens wear too soon.The pt wore lenses on (b)(6) for a day and did not wear again until (b)(6) 2014.After about 5 hrs, of wear, the pt's eyes started burning and turned bright red.He/she visited an urgent care facility the next day and was dx with bacterial keratitis ou.Several unsuccessful attempts have been made to obtain additional info.Based on the info received, dx of "bacterial keratitis" and the pt having received several months of treatment for recurrent infection, the injury is reported as worst case.The other eye is reported in #1033553-2014-00077.

Manufacturer Narrative

A device history review was performed.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 l0029g5 was processed under normal conditions.If additional info is received, will report within 30 days of receipt.Mdr reportable event trends are reviewed in quarterly management review meetings.

• Brand Name: ACUVUE 2 BRAND
• Type of Device: SOFT CONTACT LENS
• Manufacturer (Section D): LIMERICK; EI
• Manufacturer Contact: rose harrell ; po box 10157; jacksonville, FL 32247 ; 9044433647
• MDR Report Key: 4112593
• MDR Text Key: 4937244
• Report Number: 1033553-2014-00076
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/10/2014

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: 02/01/2019
• Device Lot Number: L0029G5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/19/2014
• Initial Date FDA Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2014
• 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: B&L LENS CARE SOLUTION
• Patient Outcome(s): Required Intervention