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

Lot Number 3609481430

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

Patient Problems Corneal Ulcer (1796); Keratitis (1944)

Event Date 01/13/2014

Event Type  Injury  

Event Description

On (b)(4) 2014, affiliate in (b)(4) was contacted by a pt with complaint of pain and "deposit" in her right eye.The pt reported that she went to her doctor and was told she had inflammation.The affiliate requested medical records.The translation was received on (b)(4) 2014 stating the pt had an "idiopathic" corneal ulcer and "right eye unclassified keratitis and keratoconjunctivitis." the pt was treated with ophthalmic drops, type unk.No other treatment details were provided.Details of exam were not provided.As a corneal ulcer may or may not be a serious injury and details of location, size, visual acuity or confirmation by a medical professional were not available, this event is being reported as worst case.Seven sealed blisters returned.The parameters were measured and a visual inspection was performed.The lenses meet company standards for base curve, center thickness, and diameter.No visual attributes were observed.The solution was also tested.The ph was within specification.

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.No quality events associated with this lot.The lot history review indicated lot 3609481430 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 DEFINE BRAND CONTACT LENSES
• Type of Device: SOFT CONTACT LENS, DISPOSABLE
• Manufacturer (Section D): VISTAKON; limerick ; EI
• Manufacturer Contact: rose harrell ; po box 10157; jacksonville, FL 32247 ; 9044433647
• MDR Report Key: 3687487
• MDR Text Key: 4241563
• Report Number: 1033553-2014-00029
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 03/11/2014

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: 07/01/2017
• Device Lot Number: 3609481430
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/10/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/26/2014
• Initial Date FDA Received: 03/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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: UNK LENS CARE SOLUTION
• Patient Outcome(s): Other