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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH AND LOMB LASER

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BAUSCH AND LOMB LASER Back to Search Results
Event Date 11/19/2003
Event Type  Injury  
Event Description

In 2003, i underwent a bilateral lasik procedure on my eyes at lasik plus. A dr performed the procedure. In the mos and yrs that followed i developed worsening vision, starbursts and halos, until the point that images began to double and multiply. I did not know it at the time but have since been evaluated by other drs and told that i now have a condition called ectasia and it is directly due to having underwent lasik. In 2005, my left eye had gotten so bad that i had to have a cornea transplant. My right eye also has ectasia and will require a transplant as well. For me the "problem" and "user error" is the fact that i feel lasik plus does not allow for adequate screening, lasik plus advertises as though everyone is a perfect candidate for the procedure. There has been no lasting law to prevent them from continuing explicitly advertise as an equally safe choice as wearing glasses. While it might be safe for some, it is not safe for everyone! yet the advertising touts the safety and hype. One big operational hazard that allowed the mistake on my eyes to happen was the lack of attn to detail. My chart was not given adequate time for scrutiny or discussion. I was not alerted to the fact that my corneas were thin, or that this was an important variable for a safe procedure. At the time of my procedure, i was crammed into a room with 6 other pts and not given any personal time with the dr to ask questions. Medical history is a sensitive topic, and one that should not have been discussed hastefully in front of several other pts. I wish i had known that my corneas were thinner than normal, i myself would have objected to the operation. I have a separate complaint against the lasik plus dr.

 
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Brand NameBAUSCH AND LOMB
Type of DeviceLASER
MDR Report Key1061874
Report NumberMW5007344
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 06/13/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/13/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 06/13/2008 Patient Sequence Number: 1
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