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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNK-SOFT CONTACT LENSES

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UNK-SOFT CONTACT LENSES Back to Search Results
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.
 
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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 Key6286629
MDR Text Key66061735
Report Number1033553-2017-00023
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Number of Events Reported1
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 NumberUNK-SOFT CONTACT LENSES
Device Lot NumberUNK-UNK-SOFT CONTACT LENSES
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/05/2017
Initial Date FDA Received01/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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