LUXOR OPHTHALMIC MICROSCOPES LX3 8065753062

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-05-17 for LUXOR OPHTHALMIC MICROSCOPES LX3 8065753062 manufactured by Alcon Research, Ltd. - Irvine Technology Center.

Event Text Entries

[108507544] 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


[108507545] A customer reported that during a cataract procedure, the microscope would not focus up or down. The case was aborted. The eye was filled with viscoelastic and the wound was closed. The patient was transported from operating room one to operating room three. The case was completed without further incident.
Patient Sequence No: 1, Text Type: D, B5


[117340713] The system was examined and the reported event was confirmed (via event log review). The focus clutch assembly was adjusted, which resolved the issue. The system was tested and found to meet product specifications. A review of the customer? S complaint history for the last 24 months did not show any previous complaints of this kind against the system. The system was manufactured on february 14, 2018. Based on qa assessment, the product met specifications at the time of release. The root cause can be attributed to a non-conforming focus clutch assembly. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2028159-2018-01023
MDR Report Key7521913
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-05-17
Date of Report2018-08-16
Date of Event2018-04-27
Date Mfgr Received2018-07-26
Device Manufacturer Date2018-02-14
Date Added to Maude2018-05-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. BRYAN BLAKE
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
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameLUXOR OPHTHALMIC MICROSCOPES
Generic NameMICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC
Product CodeHRM
Date Received2018-05-17
Model NumberLX3
Catalog Number8065753062
Lot NumberNA
ID Number380657530625
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. Required No Informationntervention 2018-05-17

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