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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WAVELIGHT AG (PRESSATH) ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM

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WAVELIGHT AG (PRESSATH) ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Model Number 8065990600
Device Problem Appropriate Term/Code Not Available
Event Date 06/11/2009
Event Type  Injury  
Manufacturer Narrative

Determination of root cause. Assessment: the territory manager (tm) reviewed the log file for the date and time of this patient's surgery and found the incorrect treatment had been selected for this patient. During the on-site investigation, the tm verified that the system was operating to specifications. Non-product factors including patient response to the laser ablation, patient healing characteristics and preoperative patient selection were not reviewed since patient records were not provided. Conclusion: based on the results of the investigation of product and non-product factors, the device was not likely to be a contributor to the patient's outcome, however, an incorrect treatment plan and non-product factors including patient response to the laser ablation, patient healing characteristics and preoperative patient selection may have been contributors. (b) (4). (b) (4).

 
Event Description

Adverse event: overcorrection. An optometrist reports a patient with an overcorrection following lasik surgery. During a follow-up call with the optometrist who is authorized to speak for the surgeon, it was related that the surgeon did not feel the laser contributed to the reported overcorrection. The log file review discovered the laser technician inadvertently entered the incorrect treatment for this patient. The surgeon stated he did not wish to discuss the matter further.

 
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Brand NameALLEGRETTO WAVE EYE-Q
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
WAVELIGHT AG (PRESSATH)
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 Key1600413
Report Number3003288808-2010-00004
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 06/17/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/09/2010
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 1.00
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/11/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2004
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: 02/09/2010 Patient Sequence Number: 1
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