FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

LASIK   back to search results
Patient Outcome  Other;
Event Description

Lasik -- i had high myopia -roughly -10 diopters- and large pupils. I did my research, and asked many questions about problems like halos and blurry night vision. I was assured my chances of those problems was low. Sure enough, i still have significant problems with halos and night vision more than 10 years later. And the level of correction "missed" by a significant amount -- 1. 25 on one side, -1. 75 on the other.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Type of DeviceLASIK
Baseline Device 510(K) Number
Baseline Device PMA Number
Device Event Key1007986
MDR Report Key1038034
Event Key996391
Report NumberMW5006681
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Report Date 05/02/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/02/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? No
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on February 28, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH