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Adverse Event Report

BAUSCH & LOMB, INC. BOSTON ONE STEP LIQUID ENZYMATIC CLEANER   back to search results
Patient Outcome  Other;
Event Description

Rptr has "very bad myopia" and wears contact lenses. The rptr got them last year. They came with a boston advance comfort formula that she had been using. She could not use the cleaning solution, therefore she bought the boston one step liquid enzymatic cleaning solution while visitng her daughter. She followed the product instructions for cleaning the lenses, and when she tried to wear her lenses that day, her eyes burned. Rptr could not wear the lenses, and became very sensitive to light. The next day she was due to fly back home, and had no other choice than to wear the lenses, and she suffered all day. When she got home, she called for an appointment, and was going to be seen by a woman the next saturday. When she complained, she was told to go to the emergency room.

 
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Brand NameBOSTON ONE STEP LIQUID ENZYMATIC CLEANER
Type of DeviceENZYMATIC CLEANER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
BAUSCH & LOMB, INC.
1400 n. goodman st.
rochester NY 14692
Device Event Key216114
MDR Report Key222854
Event Key209117
Report NumberMW1016278
Device Sequence Number1
Product CodeLPN
Report Source Voluntary
Report Date 05/07/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/07/1999
Is This An Adverse Event Report? No
Device Operator Invalid Data
Was Device Available For Evaluation? No Answer Provided
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on January 30, 2009

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