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  

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.

Manufacturer Narrative

Received 2 unopened cartons, containing 2 unopened vials,.No anomalies observed.The reporting facility does not know the lot code of the vials used in the procedure nor do they have the used product available for return.The 2 vials of product is from their inventory.Review of the complaint history shows no other similar complaint reported.Review of the mbr record of the lot number provided indicated that product was processed and released according to the product's acceptance criteria.Vial is compounded by (1) chemical and thermal extraction, and (2) sterile filtration of oil prior to filling.The product is then filled into its primary packaging components using aseptic processing.The product is terminally sterilized using dry heat.Following sterilization, units are 200% inspected for particulate in the solution and then packaged into pouches and sealed.The root cause of complaint condition could not be determined.Potential root cause includes: solution quality issue ¿ highly unlikely, as chemistry and microbiology data is reviewed and verified to meet regulatory requirements prior to release.Consumer mishandling - no conclusion can be made regarding the contribution of consumer mishandling as this factor is outside the control of the manufacturing facility.Event outside of manufacturer¿s control (product storage, use, and surgical practice); this could not be confirmed.A comprehensive review was performed including a review of the processes, complaint histories, batch record review, finished product testing results.The review shows that the manufacturing processes were in a state of control.Based on the acceptable mbr review and finished product test results, this lot continues to be acceptable.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: 12879880
• MDR Text Key: 281318825
• Report Number: 1610287-2021-00032
• Device Sequence Number: 1
• Product Code: LWL
• UDI-Device Identifier: 00380656011873
• UDI-Public: 00380656011873
• 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: Nurse
• 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: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 8065601187
• Device Lot Number: 10NJF
• 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: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BSS PLUS IRRIGATING SOLUTION.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 49 YR
• Patient Sex: Male