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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WAVELIGHT GMBH ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM

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WAVELIGHT GMBH ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Model Number 8065990631
Device Problem Unstable
Event Date 09/06/2011
Event Type  Injury  
Manufacturer Narrative

Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).

 
Event Description

Nurse reports laser is unstable, and a patient that underwent surgery for 2 diopters of myopia resulted in 9 diopters of hypermetropia postoperatively. Further information has been requested.

 
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Brand NameALLEGRETTO WAVE EYE-Q
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
WAVELIGHT GMBH
doellnitz 5
pressath 9269 0
GERMANY 92690
Manufacturer (Section G)
WAVELIGHT GMBH
doellnitz 5
pressath 9269 0
GERMANY 92690
Manufacturer Contact
paul nitschmann
6201 south freeway, r3-16
fort worth , TX 76134
8176152440
MDR Report Key2334675
Report Number3003288808-2011-00340
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/07/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/07/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number8065990631
Device Catalogue Number8065990631
OTHER Device ID NumberV4-1.02
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/07/2011
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/01/2010
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: 11/07/2011 Patient Sequence Number: 1
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