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	Retinal Hemorrhage (4809)
Date of Event	10/05/2023
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A physician reported that the patient experienced retinal hemorrhage after combination of cataract and vitrectomy surgery.Details of procedure was not reported.
Additional Manufacturer Narrative
Additional information is provided in sections a.1, a.3.A, b.3, b.7, e.1, h.6 and h.11.No lot code was reported by the customer; therefore, lot specific evaluation cannot be completed.All compounding, preprocessing, filling and packaging mbrs are subjected to 2 independent reviews.In addition, the following are reviewed: - all chemistry and microbial finished product results - environmental, utility, bioburden records - sanitization records.- sterilization cycles silikon 1000 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.Silikon 1000 10 ml glass bottles and the stoppers are made from silicone; the product is filled on line 21.The product is terminally sterilized using dry heat.Following sterilization, units are (b)(4) inspected for particulate in the solution and then packaged into pouches and sealed.Root cause for the complaint condition could not be determined.Potential root causes: lot specific evaluation is not possible without the lot code being reported.No further action warranted at this time.The manufacturer internal reference number is: 2024-70828 h.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 20338707
• Report Number: 1610287-2024-00048
• Device Sequence Number: 12713965
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 12/24/2024
• 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: Other
• Patient Sex: Male