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 company representative,health report with the FDA on 2020-03-30 for ORA SYSTEM 2000 8065998327 manufactured by Alcon Research, Llc - Irvine Technology Center.

Event Text Entries

[188219017] The company clinical applications specialist (cas) reviewed the images and calculations. It was noted the surgeon was trying to give the patient a balance without compensating the patient? S near vision. The root cause of the reported event cannot be determined conclusively. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[188219018] A customer reported an unaccounted for miss with the toric intraocular lens in combination with the system's measurements. The patient had an unexpected outcome and reports blurry vision. The patient has been using contact lenses but reports no improvement with vision. The patient will undergo photorefractive keratectomy at a later date. Additional information received states the patient's eye is in line with the center of intraocular lens. The patient is only using the soft contact lenses to give a balance to see what works best for him without compensating the near vision. 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 Number2028159-2020-00289
MDR Report Key9896904
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2019-11-26
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-30
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. 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 Received2020-03-30
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. Other 2020-03-30

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