ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM 8065750290

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-06-18 for ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM 8065750290 manufactured by Alcon - Irvine Technology Center.

Event Text Entries

[3520713] A customer reported a system message was received during a retinal procedure. The system was exchanged and the procedure was completed. There was no pt harm.
Patient Sequence No: 1, Text Type: D, B5


[10819060] Investigation including root causes analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable info becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2028159-2013-01142
MDR Report Key3189320
Report Source05
Date Received2013-06-18
Date of Report2013-05-21
Date of Event2013-05-21
Date Mfgr Received2013-05-21
Device Manufacturer Date2008-03-01
Date Added to Maude2013-06-28
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 FDA0
Event Location0
Manufacturer ContactARTHUR CIOCIOLA
Manufacturer Street6201 SOUTH FREEWAY TC-40
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152442
Manufacturer G1ALCON - IRVINE TECHNOLOGY CENTER
Manufacturer Street15800 ALTON PKWY.
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 NameACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM
Generic NameENDOILLUMINATOR
Product CodeMPA
Date Received2013-06-18
Model NumberNA
Catalog Number8065750290
Lot NumberNA
ID Number1.18-2.18
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON - IRVINE TECHNOLOGY CENTER
Manufacturer Address15800 ALTON PKWY. IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2013-06-18

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