BIOTRUE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-27 for BIOTRUE manufactured by .

Event Text Entries

[4410965] Used bio true contact solution exp 02/2016 lot gb14106 3235802 bl401413:002 and a fresh pair of bausch and lomb pure vision 2 contacts lot r38535514 exp 08/2016 and within 2 hours started to have blurry vision. Immediately went to eye doctor ophthalmologist and e. R. And then cornea specialist. Diagnosed with corneal edema and worsening corneal abrasion on right eye. Was essentially blind in both eyes for 4 days. Two contacts, q 30 day. Reason for use: presbyopia. Event abated after use stopped: yes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5036368
• MDR Report Key: 3842889
• Date Received: 2014-05-27
• Date of Report: 2014-05-26
• Date of Event: 2014-05-22
• Date Added to Maude: 2014-06-03
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: BIOTRUE
• Generic Name: CONTACT SOLUTION
• Product Code: LYL
• Date Received: 2014-05-27
• Lot Number: G1314106
• ID Number: 3235802
• Device Expiration Date: 2016-02-29
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0

Device Sequence Number: 2

• Brand Name: PURE VISION 2
• Generic Name: CONTACT LENS
• Product Code: LPM
• Date Received: 2014-05-27
• Lot Number: R38535514
• Device Expiration Date: 2016-08-31
• Device Sequence No: 2
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-05-27