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

MAUDE Adverse Event Report: WAVELIGHT AG ALLEGRETTO WAVE EYE-Q 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
 

WAVELIGHT AG ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Model Number 8065990600
Device Problem Unknown (for use when the device problem is not known)
Event Date 02/11/2009
Event Type  Injury  
Event Description

An administrative assistant reports a possible overcorrection of one eye following refractive surgery. Additional information provided by the surgeon indicated this patient previously had bilateral cataract extraction with multi-focal intraocular lens (iol) implanted. The patient was happy with the near vision, but wanted the distance vision improved in the left eye. The surgeon performed a yag, which didn't help. Six months following the iol implant surgery, the patient was still dissatisfied with his distance vision in his left eye and the surgeon performed a prk procedure on this patient's left eye. At approximately 5 weeks post-prk surgery, the surgeon stated the corneal surface looked reasonably intact with very minimal punctate. The patient exhibited ucva of 20/50-compared to pre-prk surgery of 20/30-20/40. Bcva post-prk surgery was 20/20. The manifest refraction post-prk surgery showed the patient to be overcorrected in the left eye. Additional info has been requested. The safety and effectiveness of this laser system has not been established for patients with previous corneal or intraocular surgery. (this would include iol implants. ).

 
Manufacturer Narrative

The log file for this surgery was reviewed by the territory manager and indicated the surgery was completed without any errors, messages or interruptions. Energy, voltage and tracker values were stable and within specs. This analysis indicated the device was operating within specifications during the time of this patient's surgery. A review of the complaint database for the previous 12 months revealed no other similar complaints for this system. Investigation including root cause analysis is still in progress. A supplemental mdr will be filed when additional information becomes available.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameALLEGRETTO WAVE EYE-Q
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
WAVELIGHT AG
doellnitz 5
pressath 9269 0
GERMANY 92690
Manufacturer (Section G)
WAVELIGHT AG (PRESSATH)
doellnitz 5
pressath 9269 0
GERMANY 92690
Manufacturer Contact
charles dolbee
6201 south freeway, r7-18
fort worth , TX 76134
8175518317
MDR Report Key1399555
Report Number3003288808-2009-00009
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 05/06/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/05/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number8065990600
Device Catalogue Number8065990600
OTHER Device ID NumberPR-V2-1.02
Was Device Available For Evaluation? Yes
Date Manufacturer Received05/06/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2005
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: 06/05/2009 Patient Sequence Number: 1
-
-