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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 Patient-Device Incompatibility (2682)
Patient Problems Foreign Body Sensation in Eye (1869); Keratitis (1944); Blurred Vision (2137)
Event Date 11/19/2018
Event Type  Injury  
Manufacturer Narrative
The device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.No udi required as this device was out of production prior to the september 24, 2014 udi regulation date.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
An optometrist reported a patient with diffuse lamellar keratitis right greater then left three days following lasik treatment.The patient reported a foreign body sensation and computer distance vision is blurry.The topical steroids were increased.Additional information requested.There are two related reports for this patient.This report addresses the patient's right eye, and another manufacturer report will be filed for the fellow eye.
 
Manufacturer Narrative
A review of the technical service onsite history showed no abnormalities that could have contributed to this event.The laser was successfully verified prior to the treatment.The root cause could not be identified conclusively.The manufacturer internal reference number is: (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 Key8160841
MDR Text Key130231983
Report Number3003288808-2018-01935
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 health professional
Type of Report Initial,Followup
Report Date 02/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 11/19/2018
Initial Date FDA Received12/13/2018
Supplement Dates Manufacturer Received01/31/2019
Supplement Dates FDA Received02/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age30 YR
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