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

Catalog Number	8065601187
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/18/2025
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 customer reported that item came in broken, when the circulating nurse attempted to take the product out of the box he had a cut.Procedure details were not reported.Additional information has been requested.New information received indicating the vial appeared intact inside of the plastic bag and oil was inside the bag outside of the vial.User wound was washed and dermabond on the cut.Cut was healed.Another vial of silicone oil was opened and used for the procedure.
Additional Manufacturer Narrative
Additional information has been provided in sections h.6 and h.11.No sample was returned.Photo shows the variable data of the carton.Retention sample testing is not required based on assessment performed.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.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.Per monthly trending, no associated trend alert(s) were observed.All complaints are reviewed on a monthly basis, and corrective actions will be defined if required.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: 23025982
• Report Number: 1610287-2025-00025
• Device Sequence Number: 9514591
• Product Code: LWL
• UDI-Device Identifier: 00380656011873
• UDI-Public: (01)00380656011873(17)271231(11)250114(10)12PPP
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P950008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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: 12PPP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/23/2025
• Date Device Manufactured: 01/14/2025
• 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; Other
• Patient Sex: Unknown