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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/01/2023
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.Linton e, jasani k.Subretinal silicone oil: oct imaging findings and surgical management of a rare and unusual iatrogenic complication of retinal detachment surgery.Bmj case rep/ 2023.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A literature article reported that a patient with underlying condition of floaters and foggy vision in his right eye, macular off retinal detachment with a super nasal horseshoe tear underwent vitrectomy using an ophthalmic viscosurgical device (ovd) as tamponade.After routine vitrectomy, retinal breaks were identified and marked with diathermy.Subretinal fluid was then drained prior to end laser retinopexy around the retinal breaks.Fluid air exchange was performed and while completing the peripheral end laser, the infusion line was displaced and the eye became hypotonous.Post application of ovd as tamponade and all ports were sutured, the retina appeared flat.Visual acuity on postoperative day 1 was demonstrated 1.0 logmar in the right eye and the intraocular pressure (iop) was 13 mm hg.The suprachoroidal hemorrhage had almost fully resolved aside from a small residual area superiorly.Optos color images (optos, california) and heidelberg optical coherence tomography (oct) images of the right eye on day 1 postoperatively demonstrate the subretinal bubbles (arrows).The oct demonstrates a large convex subretinal elevation with hypo reflective choroidal shadow at the edges of the bubble (arrow).There were also several smaller subretinal bubbles seen around the posterior pole (arrows).Upon follow up demonstrated persistence of the subretinal bubbles and no migration or shrinkage hence it was decided to remove bubbles form retina.A small drainage retinotomy was made over the main bubble, and oil bubbles were visibly released, a further retinotomy was made over the other large inferior retained oil bubble which was successfully drained.Fluid air exchange successfully flattened the retina, and a temporary gas tamponade was used.
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 products provides indications for use, contraindications, warnings, precautions, and directions for use to ensure proper use of the product.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: 16830780
• Report Number: 1610287-2023-00017
• Device Sequence Number: 19287904
• Product Code: LWL
• UDI-Device Identifier: 00380656011873
• UDI-Public: 00380656011873
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/29/2023

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: 04/05/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 07/29/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION SYSTEM.; DIATHERMY.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male