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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WAVELIGHT EX500 EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM
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WAVELIGHT EX500 EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Catalog Number 8065990713
Device Problem Unintended System Motion (1430)
Patient Problem Insufficient Information (4580)
Event Date 06/16/2021
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 manufacturer internal reference number is: (b)(4).
 
Event Description
A nurse reported a laser shutter issue during surgery.No patient harm was reported.A company representative assisted the doctor with resolving the reported issue.
 
Manufacturer Narrative
A review of the device history record (dhr) traceable to the reported serial number indicates that the product was processed and released according to the product¿s acceptance criteria.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
MDR Report Key12140810
MDR Text Key260684541
Report Number3003288808-2021-00328
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 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065990713
Was Device Available for Evaluation? No
Date Manufacturer Received09/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2013
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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