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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 8065990739
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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.The device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.No udi required due to this device being out of production prior to the september 24, 2014 udi regulation date.(b)(4).
 
Event Description
A facility representative reported a shutter two defective error during surgery.Additional information has been requested.
 
Manufacturer Narrative
Additional information provided in d.10., h.3., h.6., and h.10.During technical onsite visit the field service engineer (fse) replaced shutter 2 and performed system verification.System is operating within specifications.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 Key9197416
MDR Text Key168199293
Report Number3003288808-2019-01021
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 health professional
Type of Report Initial,Followup
Report Date 02/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065990739
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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