MAUDE Adverse Event Report: VISTAKON 1 DAY ACUVUE MOIST BRAND CONTACT LENSES; SOFT CONTACT LENS, DISPOSABLE

Lot Number 2058370432

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

Patient Problems Corneal Ulcer (1796); Unspecified Infection (1930); Keratitis (1944); Red Eye(s) (2038)

Event Date 04/01/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, our affiliate in (b)(6) reported a pt with an ulcer od.The ulcer was reported "at the right side of conjunctiva".The cornea was reported as "fine" by the pt.The report states the pt's "eyes were fine on insertion and after removal; however, after 2-3 hours after removal her eyes became red.Pt went to see an eye doctor and was diagnosed with ulcer".The pt was rx with tobra eye drops, vigamox eye drops 0.5% and refresh plus eye drops 0.5%.On (b)(6) 2014, our affiliate in (b)(6) received treatment records.On (b)(6) 2014, we received a translation of the treatment record and noted the statement "pt has been diagnosed and treated with antibiotic eye drops due to microbial keratitis of the right eye.Further monitoring by visit is required".The status was changed to indicate a reportable event.No additional info was provided.Suspect product was reported as discarded by the pt but lot info was provided.Remaining lenses were requested but not returned.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.Al sterilization requirements were successfully completed.No quality events associated with this lot.The lot history review indicated split lot # 2058370432 was manufactured under normal conditions.If additional info is received, will report within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: 1 DAY ACUVUE MOIST BRAND CONTACT LENSES
• Type of Device: SOFT CONTACT LENS, DISPOSABLE
• Manufacturer (Section D): VISTAKON; jacksonville FL
• Manufacturer Contact: rose harrell ; po box 10157; jacksonville, FL 32247 ; 9044433647
• MDR Report Key: 3888004
• MDR Text Key: 4422372
• Report Number: 1033553-2014-00044
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2014

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: 02/01/2018
• Device Lot Number: 2058370432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2014
• Initial Date FDA Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LENS CARE SOLUTION NOT REPORTED
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 21 YR