ORA SYSTEM 2000 8065998327

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 2020-03-18 for ORA SYSTEM 2000 8065998327 manufactured by Alcon Research, Llc - Irvine Technology Center.

Event Text Entries

[183890524] 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. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[183890525] A healthcare professional reported incorrect readings during cataract surgery with intraoperative aberrometry; the planned lens would correct 4. 5 diopters of astigmatism but the system suggested no cylinder correction was needed. The patient had an intraocular lens exchange two weeks later with a replacement lens of the same diopter but toric correction as previously planned. Additional information received; following the initial surgery, the patients vision wasn't sharp due to the uncorrected astigmatism. The patient is still in the post operative period and prognosis is not known.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028159-2020-00244
MDR Report Key9846245
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-18
Date of Report2020-03-17
Date Mfgr Received2020-02-28
Date Added to Maude2020-03-18
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 G1ALCON RESEARCH, LLC - 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 Report3

Device Details

Brand NameORA SYSTEM 2000
Generic NameABERROMETER, OPHTHALMIC
Product CodeNCF
Date Received2020-03-18
Model NumberNA
Catalog Number8065998327
Lot NumberASKU
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
Manufacturer Address15800 ALTON PARKWAY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-18

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