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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH & LOMB, INC. BAUSCH & LOMB TECHNOLAS EXCIMER LASER 217A NONE

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BAUSCH & LOMB, INC. BAUSCH & LOMB TECHNOLAS EXCIMER LASER 217A NONE Back to Search Results
Event Date 03/29/2007
Event Type  Injury  
Event Description

Received lasik surgery in 2007. Since surgery i have had much trouble adjusting to new vision including loss of near vision that was not a factor previously, even with glasses -pre-surgery- on for nearsightedness. This effect was not explained to me before surgery. I experience ghosting in both eyes, more severely in right eye. Both eyes experience starbursts, daybursts, halos, and glare. I experience double vision when i look to my extreme left that i did not have before surgery. I have had a noticeable increase in floaters in both eyes, but especially severe in the right eye. Both eyes are noticeably drier than before surgery. I never had any dry eye before lasik surgery, not even once. Distance vision is noticeably not as clear and sharp as before surgery with glasses. Overall vision is significantly reduced and less functional than before lasik surgery. Overall quality of life is significantly reduced as i have experienced and continue to experience digestive issues and psychological disturbances that directly coincided with lasik surgery.

 
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Brand NameBAUSCH & LOMB TECHNOLAS EXCIMER LASER 217A
Type of DeviceNONE
Manufacturer (Section D)
BAUSCH & LOMB, INC.
180 e. via verde drive
san dimas CA 91773
MDR Report Key1064265
Report NumberMW5007403
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 06/22/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/22/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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? No

Patient TREATMENT DATA
Date Received: 06/22/2008 Patient Sequence Number: 1
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