LUXOR OPHTHALMIC MICROSCOPES LX3 8065752560

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-30 for LUXOR OPHTHALMIC MICROSCOPES LX3 8065752560 manufactured by Alcon Research, Ltd. - Irvine Technology Center.

Event Text Entries

[118874967] 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).
Patient Sequence No: 1, Text Type: N, H10


[118874968] A healthcare professional reported that the microscope head feels loose and unsteady after moving the scope. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


[132417292] The system was examined and the reported event was confirmed. The company representative tightened the four inner screws in the bottom plate of the coupler above the libero to resolve the issue. The optics were also cleaned as a preventive measure. The system was tested and found to meet product specifications. The system was manufactured on june 5, 2015. Based on qa assessment, the product met specifications at the time of release. The root cause can be attributed loose screws in the libero coupler. How or when the screws became loose is unable to be determined the manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2028159-2018-01838
MDR Report Key7833521
Date Received2018-08-30
Date of Report2019-01-08
Date Mfgr Received2018-12-20
Device Manufacturer Date2015-06-05
Date Added to Maude2018-08-30
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 ContactMS. CINDY MILAM
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152230
Manufacturer G1ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
Manufacturer Street15800 ALTON PARKWAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Details

Brand NameLUXOR OPHTHALMIC MICROSCOPES
Generic NameMICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC
Product CodeHRM
Date Received2018-08-30
Model NumberLX3
Catalog Number8065752560
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
Manufacturer Address15800 ALTON PARKWAY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-08-30

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