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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 Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 07/02/2018
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.No udi required due to this device was out of production prior to the september 24, 2014 udi regulation date.The manufacturer internal reference number is: (b)(4).
 
Event Description
A customer reported excessive arf/ premix use or leak.Additional information has been requested.
 
Manufacturer Narrative
Additional information provided in d.10., h.3., h.6., and h.10.A review of the device history record was traceable to the reported serial number indicating that the product was processed and released according to the product¿s acceptance criteria.During an onsite visit, the field service engineer replaced the laserhead and successfully completed system verification to specification.Root cause is a worn laserhead.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 Key10977282
MDR Text Key221271071
Report Number3003288808-2020-00765
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
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
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? Yes
Date Manufacturer Received01/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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