SILIKON 1000 OIL 8065601185

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-02-22 for SILIKON 1000 OIL 8065601185 manufactured by Alcon - Fort Worth / Alcon Laboratories Inc.

Event Text Entries

[21752242] A surgeon reported severe emulsification of this product by ten weeks following its use during a pars plana vitrectomy procedure. The surgeon reported two pts were affected. He also reported the product (oil) was removed but because of the emulsification, the eye still has some oil and there is anterior chamber and vitreous cellular reaction. In a f/u, the surgeon reported that for this pt, the retina re-detached in (b)(6) 2011 and a repeat vitrectomy was performed. The surgeon reported the eye is inflamed with emulsified oil below the gas bubble and the intraocular pressure (iop) was 8 mmhg. The surgeon stated the retinal view was poor and he was unable to determine if the retina was flat. Add'l info has been requested. There are two medical device reports associated with this event. This report is for the first pt.
Patient Sequence No: 1, Text Type: D, B5


[21856602] Eval summary - no sample was provided by the customer. A review of the mfg record for this lot was requested. The supplier reviewed the batch records for lot tphw-02-05, as well as three lots produced before and afterwards. Retain samples were reviewed and verified that samples do not appear emulsified. No root cause could be determined. There have been no other complaints reported in the lot number. Add'l info has been requested. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1610287-2012-00028
MDR Report Key2468840
Report Source01,05
Date Received2012-02-22
Date of Report2012-01-24
Date of Event2011-12-01
Date Mfgr Received2012-01-24
Device Manufacturer Date2010-05-01
Date Added to Maude2012-02-28
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 ContactPAUL NITSCHMANN
Manufacturer Street6201 SOUTH FREEWAY R3-16
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152440
Manufacturer G1ALCON - FORT WORTH / ALCON LABORATORIES, INC
Manufacturer Street6201 SOUTH FREEWAY
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal Code76134
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameSILIKON 1000 OIL
Generic NameFLUID, INTRAOCULAR
Product CodeLWL
Date Received2012-02-22
Model NumberNA
Catalog Number8065601185
Lot NumberTPHW-02-05
ID NumberNA
Device Expiration Date2012-04-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON - FORT WORTH / ALCON LABORATORIES INC
Manufacturer Address6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-02-22

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