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	Cataract (1766); Retinal Degeneration (2049); Blurred Vision (2137); Loss of Vision (2139)
Date of Event	06/23/2022
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 after the vitreoretinal surgery, patient experienced poor/blurry vision, central vision loss and developing cataract.Post cataract removal, central vision loss confirmed and implication on optic nerve.Patient can saw 20/400 with central vision loss.Investigation re further complications was ongoing.Silikon oil was supplied by hospital.Post surgery, patient had retinal atrophy.
Additional Manufacturer Narrative
No sample received.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 sample was not received for evaluation; therefore, the condition of the product could not be evaluated and the root cause complaint condition could not be determined.Solution quality issue ¿ highly unlikely, as chemistry and microbiology data is reviewed and verified to meet 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 outside of manufacturer control (product storage, use, and surgical practice); this could not be confirmed.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.The manufacturer internal reference number is:(b)(4).
Additional Manufacturer Narrative
Additional information is provided in sections a.1., a.2., a3.A., a.4., b.5., d.4 and h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information provided by reporter that patient's left eye blindness due to the oil toxicity.Current state of vision of patient was blind.

• 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: 17265397
• Report Number: 1610287-2023-00028
• Device Sequence Number: 7911883
• Product Code: LWL
• UDI-Device Identifier: 00380656011873
• UDI-Public: (01)00380656011873(17)231031(11)211109(10)10XX8
• Combination Product (Y/N): N
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2025

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 Expiration Date: 10/31/2023
• Device Catalogue Number: 8065601187
• Device Lot Number: 10XX8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 09/12/2023; 02/27/2025
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 10/09/2023; 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2021
• 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 Age: 54 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White