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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH & LOMB HANSATOME MICROKERATOME

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BAUSCH & LOMB HANSATOME MICROKERATOME Back to Search Results
Event Date 08/11/2000
Event Type  Injury  
Event Description

I received lasik surgery with a manual microkeratome that was approved by the fda and a nidek laser that was approved by the fda under a pma. In 2000, i suffered a microkeratome failure and the user's colleague admitted to me subsequently in late 2006 that the user of the microkeratome routinely reused the microkeratome blades contrary to the fda's labeling - they are labeled as single use devices, suds. Recently, another patient contacted me who was injured by the same doctor in a similar fashion. I suffered not only a microkeratome failure, but further adverse events including, but not limited to, permanent and severe flap melt, dlk, keratitis, mebomian and lacrimal gland dysfunction, dry eye, loss of day and night vision, loss of vision quality, etc. Emory university has evidence of up to 4 times of an increase in actual suicides from patients who were "satisfied" with their lasik. I know of many patients who killed themselves because their lasik injuries were so severe. Dates of use: ongoing. Diagnosis: lasik. Lasik vision institute no reprocessing 21% or more of users reuse on mult patients.

 
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Brand NameHANSATOME MICROKERATOME
Type of DeviceMICROKERATOME
Manufacturer (Section D)
BAUSCH & LOMB
1 bausch & lomb place
rochester NY 14604 270
MDR Report Key1310529
Report NumberMW5009925
Device Sequence Number1
Product CodeHNO
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/20/2009
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received01/20/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? Yes

Patient TREATMENT DATA
Date Received: 01/20/2009 Patient Sequence Number: 1
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