MAUDE Adverse Event Report: UNK-SOFT CONTACT LENSES

Catalog Number UNK-SOFT CONTACT LENSES

Device Problem No Apparent Adverse Event (3189)

Patient Problems Unspecified Infection (1930); Irritation (1941)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On 05jan2017 a posting was placed on a social media web site regarding an event reported by a patient (pt).The pt reported the following: ¿i'm outraged! has been having quality control problems with your contact lenses for over 6 months to a year.I got a free box from an on-line provider and still they irritated my eyes.I got an infection.The quality is so bad.They're so thin, they bend on my finger before i can get them in my eyes and i just went to a doctor today and found out i have scarring on my cornea and i get on the website that states what you're using in the contact lenses is causing corneal laceration.¿ multiple attempts were made on the social media website to contact the pt for additional information.No additional information has been received.The date of event, diagnosis, treatment, and affected eye(s) are unknown.The acuvue product, lot number, and product availability for return for evaluation are also unknown.The event is being reported as a worst case event.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: UNK-SOFT CONTACT LENSES
• Type of Device: UNK-SOFT CONTACT LENSES
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 6286629
• MDR Text Key: 66061735
• Report Number: 1033553-2017-00023
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2017

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 Catalogue Number: UNK-SOFT CONTACT LENSES
• Device Lot Number: UNK-UNK-SOFT CONTACT LENSES
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention