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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT EX500 EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM
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WAVELIGHT GMBH WAVELIGHT EX500 EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Catalog Number 8065990794
Device Problem Device Sensing Problem (2917)
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 record (dhr) for the device has been reviewed.The associated device was released based on company's acceptance criteria.The manufacturer internal reference number is: (b)(4).
 
Event Description
A customer reported that centration was different in the microscope versus with the eye tracker.Patients outcome after procedure was good.Additional information has been requested.
 
Manufacturer Narrative
During technical onsite visit, the field service engineer (fse) completed system verification.The system was operating within specifications.No problem detected.No technical root cause was identified as the product was found to be within specifications during onsite visit.The root cause could not be determined conclusively.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
WAVELIGHT EX500 EXCIMER LASER
Type of Device
OPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
WAVELIGHT GMBH
am wolfsmantel 5
erlangen 91058
GM  91058
MDR Report Key8212783
MDR Text Key132046787
Report Number3003288808-2019-00005
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,other
Type of Report Initial,Followup
Report Date 03/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065990794
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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