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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO MANUFACTURING USA LLC VISX EXCIMER LASER

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AMO MANUFACTURING USA LLC VISX EXCIMER LASER Back to Search Results
Event Date 01/01/1995
Event Type  Injury  
Event Description

A report was received from fda from a lasik patient, reporting the following experience: "since childhood i've had severe myopia. Without the use of glasses, i could not see well more than a few inches away. Know this, my ophthalmologist recommended i be evaluated for a study using laser surgery to correct my myopia. After very thorough examinations and testing, i was deemed a good candidate for the study. In 1994, i underwent successful excimer laser photocoagulation on my right eye. In 1995, i underwent the same procedure on my left eye (which had a refractory of -8. 5 diopters). This resulted in an accidental overcorrection, leading to scarring and compromised my vision. To work, i had to wear special glasses and use lights, which lead to incapacitating headaches. A repeat procedure performed in 1996, did not improve my vision. In early 2007, i applied for disability due to my visual changes and headaches. While in process of applying, i have been examined by several doctors and undergone dozens of tests. I've also obtained all of my medical records including those from the study. " "during this process, as i researched and obtained more data, i became aware these procedures had been performed pre fda standards. The fda reports i found state lasers have not been shown safe and effective for several nearsightedness (more that -7 diopters). The fda also reports that unapproved lasers could potentially cause severe eye injury. Quoting other sources (complications of laser keratomileusis with excimer laser) correction of more than 6. 0 - 7. 0 diopters should be considered a relative contraindication for prk at this time. - eyes like mine".

 
Manufacturer Narrative

Product, clinic, and reporter are unknown.

 
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Brand NameVISX EXCIMER LASER
Manufacturer (Section D)
AMO MANUFACTURING USA LLC
510 cottonwood drive
milpitas CA 92705 493
Manufacturer (Section G)
AMO MANUFACTURING USA LLC
510 cottonwood drive
milpitas CA 92705 493
Manufacturer Contact
carol kail
1700 e. st. andrew place
santa ana , CA 92705-4933
7142478598
MDR Report Key1490841
Report Number3006695864-2009-00083
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Other
Type of Report Initial
Report Date 09/14/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/21/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Date Manufacturer Received09/14/2009
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 09/21/2009 Patient Sequence Number: 1
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