BIO-TRU

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-23 for BIO-TRU manufactured by Bausch & Lomb.

Event Text Entries

[68497727] God bless my wife (she's an rn, for 25+ years). She had been wearing contacts for years. After many unsuccessful tries to put them in, she showed me how to do it. She instructed me to put a drop of bio-tru on the contact of my right pinky finger. And with the contact and the bio-tru open up my left eye lid pull down my lower eye lid and insert the lens with the solution on it. And low and behold it sucked right to my left eye. I started screaming omg it's burning so bad. She said that she wears contacts all the time and never ever felt what i'm feeling. Sure enough i took out my contacts. Although for about 2+ years and also used the contacts for my acting career starting in 2002 now on indefinite hold, saw a doctor in (b)(6) that stated that the skin was burnt off my eyes. He asked me what cleaner did i use i showed him the bottle of bio-tru. He said well that product has burned the skin off my eyes and please don't use it anymore. He gave me drops that only he had in his office, then gave me an rx for an antibiotic to ease the infection. To this day, the skin is still off my eyes and nothing can be done. Eventually this will lead to macular degeneration. Some time in mid 2014 i went to an eye professional in (b)(6) who gave me a complete eye examination. Upon his examination, i don't have dry eye the skin was burned off my eyes from the product bio-tru. Which states that the formula was based on the ph of your eyes. Certainly saw my eye doctor. Frequency: 4 times a day. How was it taken or used: ophthalmic. Date the person first started taking or using the product: (b)(6) 2013. Date the person stopped taking or using the product: (b)(6) 2014. Equal to the ph of my eyes fluid.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5068141
MDR Report Key6360820
Date Received2017-02-23
Date of Report2017-02-23
Date of Event2014-04-04
Date Added to Maude2017-02-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBIO-TRU
Generic NameBIO-TRU
Product CodeLYL
Date Received2017-02-23
Device Expiration Date2014-04-14
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBAUSCH & LOMB


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-02-23

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