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

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  

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.

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).

• Brand Name: SILIKON 1000 OIL
• Type of Device: FLUID, 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 Key: 12879881
• MDR Text Key: 281318936
• Report Number: 1610287-2021-00033
• Device Sequence Number: 1
• Product Code: LWL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950008
• Number of Events Reported: 1
• 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 Received: 11/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 8065601187
• Device Lot Number: 10KMD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2021
• 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