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

MAUDE Adverse Event Report: ALCON - ORLANDO TECHNOLOGY CENTER APEX PLUS OPHTHALMIC EXCIMER LASER SYSTEM

  • 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
 

ALCON - ORLANDO TECHNOLOGY CENTER APEX PLUS OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Device Problem Unknown (for use when the device problem is not known)
Event Date 06/29/2000
Event Type  Injury  
Manufacturer Narrative

Investigation including root cause analysis is in progress.

 
Event Description

Received a voluntary medwatch that was submitted by a pt. The pt stated she had bilateral monovision lasik 8 yrs ago. Pt stated she was told she was an 'ideal candidate' for lasik surgery. Pt stated following lasik surgery, she has glare, aberrations, starbursts and halos. Night vision disturbances have 'seriously restricted many after-dark activities including traveling outside of town to family events, personal recreation and business opportunities'. Pt also stated these 'vision defects are apparently permanent and uncorrectable'.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAPEX PLUS
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery dr.,
ste 500
orlando FL 32826
Manufacturer (Section G)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery dr.
suite 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1074463
Report Number1061857-2008-00122
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 05/20/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/19/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/30/2008
Date Manufacturer Received05/20/2008
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: 06/19/2008 Patient Sequence Number: 1
-
-