LASER PROBES 8065751591

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 2018-11-21 for LASER PROBES 8065751591 manufactured by Alcon Research, Ltd. - Irvine Technology Center.

Event Text Entries

[128199287] The sample has been received and in-house evaluation is in progress. 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


[128199288] A customer reported that during a combined cataract and vitrectomy procedure, the laser probe became caught in the middle of the trocar when inserted. The laser probe was switched out to complete the case. There was no patient harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028159-2018-02443
MDR Report Key8094875
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-11-21
Date of Report2019-02-08
Date of Event2018-10-24
Date Mfgr Received2019-01-30
Device Manufacturer Date2018-01-12
Date Added to Maude2018-11-21
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 ContactMS. CINDY MILAM
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152231
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 Report3

Device Details

Brand NameLASER PROBES
Generic NameINSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED
Product CodeHQE
Date Received2018-11-21
Returned To Mfg2018-11-15
Model NumberNA
Catalog Number8065751591
Lot Number18010957X
Device Expiration Date2019-12-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
Manufacturer Address15800 ALTON PARKWAY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-21

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