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

Catalog Number	8065601187
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Edema (2020)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A physician reported after the patient underwent ophthalmic surgery, the patient developed acute pulmonary edema that say day night and was transferred to hospital.The patient was in a state of using extracorporeal membrane oxygenation temporarily, but now that the patient¿s condition had calmed down and was returned from the hospital.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received indicating that the patient had underlying condition like retinal detachment, ulcerous colitis, serratus tear, proliferative changes, and subfoveal choroidal hemorrhage after trauma, and the patient was seen one month after the trauma that caused the injury.Multiple other traumas, including rib fractures and auricular hematoma, had occurred in a short period of time over the past year or so.The current trauma was caused by a falling frying pan at home.
Additional Manufacturer Narrative
Product was 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.Root cause could not be determined.Potential root causes include: - solution quality issue ¿ unlikely, as chemistry and microbiology data was reviewed and was found to have met 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 related to consumer physiology ¿ no conclusion can be made regarding the contribution of unique consumer physiology as this factor is outside the control of the manufacturing facility.Surgical practices cannot be confirmed, (e.G.During injection, etc.).The product labeling for silikon 1000 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
• Common Device Name: 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: 16370222
• Report Number: 1610287-2023-00005
• Device Sequence Number: 20680249
• Product Code: LWL
• UDI-Device Identifier: 00380656011873
• UDI-Public: 00380656011873
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P950008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/26/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 8065601187
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 02/14/2023; 05/01/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/15/2023; 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 37 YR
• Patient Sex: Male