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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 8065990739
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Blurred Vision (2137)
Event Date 07/21/2018
Event Type  Injury  
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.No udi required due to this device was out of production prior to the september 24, 2014 udi regulation date.(b)(4).
 
Event Description
An optometrist reported a patient with blurry vision in the left eye post lasik.It was noted the wrong axis was entered into the system at the time of treatment.Additional information requested.
 
Manufacturer Narrative
A review of the technical service onsite history showed no abnormalities that could have contributed to this event: laser was successfully verified prior to and after the treatment.User error, customer stated incorrect axis was entered.(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 Key7796999
MDR Text Key117584411
Report Number3003288808-2018-01495
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number8065990739
Was Device Available for Evaluation? No
Date Manufacturer Received11/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age27 YR
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