• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AMO MANUFACTURING USA LLC VISX EXCIMER LASER Back to Search Results
Model Number UNKNOWN
Event Date 01/01/2000
Event Type  Injury  
Event Description

A review of the maude database revealed the following voluntary report from a patient: "i was damaged by lasik in my left eye in 2000, by dr. He finally admitted that i had a decentration and wrinkles in my flap, but that he didn't have the laser to fix the problem. I had to go to a specialist in another country, to try to get my eye fixed, but it was damaged too bad and i had to receive a corneal transplant. Dr told me he would foot the bill or reimburse me for the surgeries that it would take to fix my eye, i believed him and never went to a lawyer. Once it came time to be reimbursed, he said he didn't remember saying that he would reimburse me, and my statute of limitations ran out. I never rec'd a dime from him. I had to foot the bill on this myself. I lost my house from these high surgery bills, and now, have to live with a corneal transplant because of this dr. Not one time over the years has he ever dropped a call or a letter to see how my eye was doing. This guy shouldn't even to be a dr in my opinion. He now has a clinic in another country, and i wonder how many other people he has damaged since me. ".

 
Manufacturer Narrative

Product, clinic and reporter are unknown.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key1403427
Report Number3006695864-2009-00046
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Other
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 05/18/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/08/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Date Manufacturer Received05/18/2009
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: 06/08/2009 Patient Sequence Number: 1
-
-