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 Codes	Foreign Body Sensation in Eye (1869); Intraocular Pressure Increased (1937)
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 literature article revealed that an ophthalmic silicone oil used in a vitrectomy surgery, sometimes restore in the retina might increase in intraocular pressure due to emulsification of the oil if it remains in the eye for a long period of time, it was removed a short time after surgery but in some cases it might remain at the bottom of the corner angle and be observed as translucent granules.Patients with a long intraocular lens and high intraocular pressure before silicone oil removal were more likely to have more silicone oil remaining, which might lead to an increase in intraocular pressure, and require thorough cleaning.
Additional Manufacturer Narrative
The initial decision to report was incorrect resulting in the initial report being submitted in error.This event of silicone oil remaining in eye, which might lead to an increase in intraocular pressure, and observed as translucent granules, requiring thorough cleaning, do not meet the criteria for reporting and are not considered serious adverse events.Hence no further reports will be scheduled under 1610287-2024-00033.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: 19709567
• Report Number: 1610287-2024-00033
• Device Sequence Number: 3116150
• 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
• Report Date (Section B): 08/23/2024

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): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/23/2024
• 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: Unknown