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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WAVELIGHT GMBH ALLEGRETTO WAVE EYE-Q EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM
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WAVELIGHT GMBH ALLEGRETTO WAVE EYE-Q EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Catalog Number 8065990601
Device Problems Incorrect Measurement (1383); Device Sensing Problem (2917)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/21/2018
Event Type  malfunction  
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.Manufacturing record reviewed.No abnormalities that could have contributed to this event were found.No udi required due to this device being out of production prior to the (b)(4) 2014 udi regulation date.(b)(4).
 
Event Description
A surgery assistant reported the micrometer measures the wrong depth.This was discovered while measuring depth of normal glass.There was no patient impact.
 
Manufacturer Narrative
The root cause could not be determined conclusively.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
ALLEGRETTO WAVE EYE-Q EXCIMER LASER
Type of Device
OPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
WAVELIGHT GMBH
am wolfsmantel 5
erlangen 91058
GM  91058
MDR Report Key7869178
MDR Text Key120244415
Report Number3003288808-2018-01560
Device Sequence Number1
Product Code LZS
Combination Product (y/n)N
PMA/PMN Number
P020050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065990601
Was Device Available for Evaluation? No
Date Manufacturer Received12/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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