ALLEGRETTO WAVE EYE-Q EXCIMER LASER 8065990739

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-23 for ALLEGRETTO WAVE EYE-Q EXCIMER LASER 8065990739 manufactured by Wavelight Gmbh.

Event Text Entries

[187083909] 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. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[187083910] An optometrist reported a patient had diffuse lamellar keratitis (dlk) in both eyes on superior flap day one. The patient was started on a topical steroid drop. Dlk was noted to have increased when seen on day three so steroid dosage amount was increased and patient was switched to a different topical steroid. The patient noted vision was hazy which is worse in the left eye than the right eye. The patient is frustrated but realizes that the doctor is doing everything to help out. Four days post-operatively, a topical antibiotic drop was prescribed. Right eye was noted to be resolving while the left eye was noted to be worsening. The patient is set up to see the surgeon about a possibly lift and irrigation to be done. 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003288808-2020-00219
MDR Report Key9865025
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-23
Date of Report2020-03-27
Date of Event2020-02-28
Date Mfgr Received2020-03-27
Device Manufacturer Date2007-10-29
Date Added to Maude2020-03-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JONATHAN SCHLECH
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8175514979
Manufacturer G1WAVELIGHT GMBH
Manufacturer StreetAM WOLFSMANTEL 5
Manufacturer CityERLANGEN 91058
Manufacturer CountryGM
Manufacturer Postal Code91058
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameALLEGRETTO WAVE EYE-Q EXCIMER LASER
Generic NameOPHTHALMIC EXCIMER LASER SYSTEM
Product CodeLZS
Date Received2020-03-23
Model NumberNA
Catalog Number8065990739
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWAVELIGHT GMBH
Manufacturer AddressAM WOLFSMANTEL 5 ERLANGEN 91058 GM 91058


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-23

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