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 Retinal Detachment (2047); Retinal Tear (2050); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 customer reported that while performing vitreous surgery (ppv) for the macular epithelium caused by familial exudative vitreous retinopathy (fevr) in which silicone oil (sio) invaded the superior choroidal cavity in addition to the sub retinal cavity.Patient experienced with tractional retinal detachment occurred due to contraction of the residual vitreous body around the postoperative area.Later patient underwent additional excision of the residual vitreous and performed ring-shaped fastening and sio tamponade again patient developed anterior proliferative vitreous retinopathy and a retinal tear.Sio was removed and the epiretinal membrane of the secondary macula was treated.After sio was removed the space between the choroid and the sclera around the choroid defect site remains as it is, and the sio remaining in the same site escapes into the postoperative vitreous cavity and is observed upward in a bubble shape.

Manufacturer Narrative

No lot code or sample was provided by the customer.Product is enrolled in the formulation stability program in which it is tested according to this product's stability specifications on a set schedule.Raw material testing is performed per requirements and disposition based on established acceptance criteria.All compounding, pre-processing, filling, and packaging mbrs are subjected to 2 independent reviews.A single, normal level i iba ansi z1.4 for attributes is performed for every lot manufactured.The process includes a review of the following: - all chemistry and microbial in-process and finished product results, - environmental, utility, bioburden records, - sanitization records.No sample or lot code was provided.Based on the manufacturing process (sterile filtration, silicon stopper and glass vial) the root cause of the complaint condition cannot be determined.Events outside of alcon¿s control cannot be confirmed.The product labeling for product provides indications for use, contraindications, warnings, precautions, and directions for use to ensure proper use of the product.Instructions also state, ¿all components for single use only¿.No lot code was reported or sample provided by the customer.No further action is possible at this time.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: 14157054
• MDR Text Key: 289607449
• Report Number: 1610287-2022-00022
• Device Sequence Number: 1
• Product Code: LWL
• UDI-Device Identifier: 00380656011873
• UDI-Public: 00380656011873
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P950008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065601187
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 06/16/2022
• Supplement Dates FDA Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SILIKON 1000 OIL
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female