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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC SILIKON 1000 OIL FLUID, INTRAOCULAR

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ALCON RESEARCH, LLC SILIKON 1000 OIL FLUID, INTRAOCULAR Back to Search Results
Catalog Number 8065601187
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypopyon (1913); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/26/2021
Event Type  Injury  
Manufacturer Narrative
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).
 
Event Description
A nurse reported that a patient experienced tass toxic anterior segment syndrome (tass) after the surgery. Additional information has been requested. Additional information received indicated after the vitrectomy with laser, silicone oil, membrane peel surgery the event occurred. Four + aqueous cell and hypopyon was noted. Three sutures were required and patient was prescribed with post-operative antibiotic. Cultures were performed. Vision improved and patient condition is improving.
 
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Brand NameSILIKON 1000 OIL
Type of DeviceFLUID, INTRAOCULAR
Manufacturer (Section D)
ALCON RESEARCH, LLC
6201 south freeway
fort worth TX 76134
Manufacturer (Section G)
ALCON RESEARCH, LLC
6201 south freeway
fort worth TX 76134
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key12879880
MDR Text Key281318825
Report Number1610287-2021-00032
Device Sequence Number1
Product Code LWL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P950008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number8065601187
Device Lot Number10NJF
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/27/2021 Patient Sequence Number: 1
Treatment
BSS PLUS IRRIGATING SOLUTION
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