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	Cataract (1766)
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.Chiharu iwahashi, efficacy of inner wall retinectomy for bullous schisis cavity hanging over or threatening the macula in patients with congenital x-linked , retinoschisis.Retina.43, 64¿71, 2023.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported via literature source regarding the surgical outcome of vitrectomy for bullous schisis cavity hanging over or threatening the macula in patients with congenital x-linked retinoschisis (cxlrs) and evaluated surgical techniques, including inner wall retinectomy, and the use of intraocular tamponade.The first patient in the study underwent a lens-sparing vitrectomy with the help of ophthalmic tamponade and during the follow up it was found that the patient had developed cataract in right eye.Additional surgeries such as pars plana vitrectomy (ppv), inner wall retinectomy (iwr), phacoemulsification with an intraocular lens implantation (p+i) and ophthalmic tamponade removal has been performed to treat cataract.The patient eye had maintained a clear central visual axis at the last examination.This is one of six reports for the first patient (od) involved in the event.
Additional Manufacturer Narrative
No lot code was reported by the customer; therefore, lot specific evaluation cannot be completed.Root cause for the complaint condition could not be determined.Potential root causes: solution quality issue chemistry and microbiology data must 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 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.Event related to surgical technique no conclusion can be made regarding the contribution of surgical technique.The product labeling for ophthalmic product provides indications for use, contraindications, warnings, precautions, and directions for use to ensure proper use of the product.Surgical technique, product handling and storage are unknown.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: (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: 16928956
• Report Number: 1610287-2023-00018
• Device Sequence Number: 15142659
• 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,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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): Follow-Up
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 08/09/2023
• 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; Other
• Patient Sex: Male