LASER PROBES 8065751593

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-13 for LASER PROBES 8065751593 manufactured by Alcon Research, Llc - Irvine Technology Center.

Event Text Entries

[138757979] 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


[138757980] A customer reported that during a procedure to repair a large retinal tear with a significant amount of lattice, in the left eye, the laser probe seemed to loose power and the light source and aiming beam became very dim. A second laser probe was used and there was difficulty getting a laser burn. The surgeon had to increase the laser output higher than he typically uses, as a result, a "pop" was heard and a large bubble was created. Once the bubble went away, it was observed that the laser burn had caused a focal destruction of the retina, rpe, and choroid so that the bare sclera was likely visible. There was no bleeding and the spot was fairly small and anterior. The surgeon was able to put normal burns around it. He continued to use the second probe, but then the light and aiming beam became dim. A third laser probe was used to complete the case without further incident. This is the first of two reports as it is unknown which lot was associated with the second probe.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028159-2019-00417
MDR Report Key8418896
Date Received2019-03-13
Date of Report2019-10-14
Date of Event2019-02-11
Date Mfgr Received2019-10-02
Device Manufacturer Date2018-08-02
Date Added to Maude2019-03-13
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 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, 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 NameLASER PROBES
Generic NameINSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED
Product CodeHQE
Date Received2019-03-13
Model NumberNA
Catalog Number8065751593
Lot Number18027758X
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
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 2019-03-13

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