BURATTO BIMANUAL I/A SET 170.11

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-19 for BURATTO BIMANUAL I/A SET 170.11 manufactured by Alcon Grieshaber Ag.

Event Text Entries

[100400058] 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


[100400059] An ophthalmic surgeon reported that during a vitrectomy procedure the patient experienced a posterior capsule tear. Additional information was requested but not received.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003398873-2018-00003
MDR Report Key7279696
Date Received2018-02-19
Date of Report2018-06-15
Date of Event2018-01-19
Date Mfgr Received2018-06-06
Date Added to Maude2018-02-19
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. NADIA BAILEY
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152230
Manufacturer G1ALCON GRIESHABER AG
Manufacturer StreetWINKELRIEDSTRASSE 52
Manufacturer CitySCHAFFHAUSEN 8203
Manufacturer CountrySZ
Manufacturer Postal Code8203
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Details

Brand NameBURATTO BIMANUAL I/A SET
Generic NameDEVICE, IRRIGATION, OCULAR SURGERY
Product CodeKYG
Date Received2018-02-19
Model NumberNA
Catalog Number170.11
Lot NumberF91445
ID Number7612717058286
OperatorPHYSICIAN
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON GRIESHABER AG
Manufacturer AddressWINKELRIEDSTRASSE 52 SCHAFFHAUSEN 8203 SZ 8203


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-02-19

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