DISPOSABLE ANTERIOR VITRECTOMY COAXIAL IRRIGATION SLEEVE 8065750352

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-02 for DISPOSABLE ANTERIOR VITRECTOMY COAXIAL IRRIGATION SLEEVE 8065750352 manufactured by Alcon Research, Ltd. - Houston.

Event Text Entries

[47624651] 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.
Patient Sequence No: 1, Text Type: N, H10


[47624652] A customer reported that the sleeve slid off the irrigation and aspiration tip during an eye procedure when sweeping the anterior capsule causing the anterior chamber to collapse. There was no patient harm associated with this event. A product sample was requested for evaluation.
Patient Sequence No: 1, Text Type: D, B5


[54657368] As the customer did not retain the finished goods lot number; a device history record review and lot history could not be reviewed. The customer did not retain a sample for this complaint report; visual inspection or functional testing could not be conducted. It is important to remind the customer to return all products associated with the event for a full evaluation. The root cause of the customer's complaint could not be established as a sample has not been received. Without a sample, it is not possible to isolate the root cause. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1644019-2016-00867
MDR Report Key5695628
Date Received2016-06-02
Date of Report2016-09-12
Date of Event2016-05-11
Date Mfgr Received2016-09-08
Date Added to Maude2016-06-02
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. EDDIE DARTON, MD, JD
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8175686660
Manufacturer G1ALCON RESEARCH, LTD. - HOUSTON
Manufacturer Street9965 BUFFALO SPEEDWAY
Manufacturer CityHOUSTON TX 77054
Manufacturer CountryUS
Manufacturer Postal Code77054
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameDISPOSABLE ANTERIOR VITRECTOMY COAXIAL IRRIGATION SLEEVE
Generic NameDEVICE, IRRIGATION, OCULAR SURGERY
Product CodeKYG
Date Received2016-06-02
Model NumberNA
Catalog Number8065750352
Lot NumberASKU
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LTD. - HOUSTON
Manufacturer Address9965 BUFFALO SPEEDWAY HOUSTON TX 77054 US 77054


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-06-02

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