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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 Problems Self-Activation or Keying (1557); Reset Problem (3019)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2018
Event Type  malfunction  
Manufacturer Narrative
Manufacturing record reviewed.No abnormalities that could have contributed to this event were found.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.(b)(4).
 
Event Description
A technician reported the laser self aborted treatment during refractive ablation of the left eye.The tech felt this was due to the surgeon repeatedly pressing and releasing the foot pedal too quickly and that it happed 2-3 seconds into treatment.The site reprogrammed the original treatment and repeated the eye but aborted the treatment 2-3 seconds prior to completion.Additional information received; the patient is not experiencing any symptoms of harm.
 
Manufacturer Narrative
Additional information provided.The root cause could not be identified.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 Key7659072
MDR Text Key113197474
Report Number3003288808-2018-01212
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 other
Type of Report Initial,Followup
Report Date 11/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
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? No
Date Manufacturer Received10/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age28 YR
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