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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 8065990713
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017)
Patient Problem Visual Disturbances (2140)
Event Date 03/04/2019
Event Type  Injury  
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.Device history record (dhr) for the device was reviewed.The associated device was released based on company's acceptance criteria.The manufacturer internal reference number is: (b)(4).
 
Event Description
A doctor reported unexpected results post refractive surgery.Planned patient refraction was entered incorrectly into the device.Incorrect rate was entered and astigmatism was noted by the doctor.
 
Manufacturer Narrative
The reported event was the result of an incorrectly entered refraction by the surgeon.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 Key8443285
MDR Text Key139549903
Report Number3003288808-2019-00322
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 06/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number8065990713
Was Device Available for Evaluation? No
Date Manufacturer Received06/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age25 YR
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