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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WAVELIGHT GMBH ALLEGRETTO WAVE EYE-Q; OPTHALMIC EXCIMER LASER SYSTEM
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WAVELIGHT GMBH ALLEGRETTO WAVE EYE-Q; OPTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Model Number 8065990601
Device Problem Incorrect Measurement (1383)
Patient Problem No Information (3190)
Event Date 11/04/2014
Event Type  malfunction  
Event Description
A medical engineer reported the staff suspects that the ablation depth meter measurements are incorrect.Additional info has been requested.
 
Manufacturer Narrative
Additional info has been requested.The device history records (dhr) for the device was reviewed and there were no unusual findings related to the reported issue and the product was released according to company acceptable criteria.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 info becomes available.(b)(4).
 
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Brand Name
ALLEGRETTO WAVE EYE-Q
Type of Device
OPTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
WAVELIGHT GMBH
am wolfsmantel 5
erlangen 91058
GM  91058
Manufacturer (Section G)
WAVELIGHT GMBH
am wolfsmantel 5
erlangen 9105 8
GM   91058
Manufacturer Contact
janet moran
6201 south freeway, r3-48
fort worth, TX 76134
8176152742
MDR Report Key4316651
MDR Text Key5244457
Report Number3003288808-2014-01729
Device Sequence Number1
Product Code LZS
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
P030008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 11/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8065990601
Device Catalogue Number8065990601
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/04/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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