MAUDE Adverse Event Report: BAUSCH + LOMB ADATO SIL-OL 5000 SILICONE OIL SYRINGE; FLUID, INTRAOCULAR

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Retinal Detachment (2047); Loss of Vision (2139)
Type of Reportable Event	Serious Injury
Event or Problem Description
An online article reported a case study with akreos opacification associated with 5000-centistoke silicone oil.The article reports a patient with a clinical diagnosis of subluxated intraocular lens (iol) with very poor zonular support was made.The patient underwent pars plana vitrectomy, single-piece iol removal, and scleral fixation of an akreos iol with gore tex sutures.Large holes developed during vitrectomy at 11, 1, and 7 o¿clock.The areas were secured with laser.Nine days post surgery, the patient experienced vision loss, and a peripheral retinal detachment was noted.An inferior peripheral iridotomy was created, and air was left in the anterior chamber.The next day, vision was 20/150 and the retina was attached.In addition, a small amount of fibrin could be seen on the anterior surface of the lens and a small air bubble remained in the anterior chamber.After 3 months, visual acuity decreased to 20/800 despite the retina being flat and the oct not showing any macular structural abnormalities.Possible opacification of the iol was noted.During the planned silicone oil removal, attempts to scrub the surfaces of the iol were not successful and opacification of the lens itself was confirmed.The iol was explanted and replaced with a different model anterior chamber iol.
Additional Manufacturer Narrative
Article website: https://www.Canadianjournalofophthalmology.Ca/article/s0008-4182(17)31251-6/fulltext.The lot number number is not available.Therefore a review of the device history record could not be performed.Investigation of this event is ongoing and a supplemental report will be submitted upon completion of investigation.
Additional Manufacturer Narrative
Updated d4, g3, h2, h6, h10 the device was not returned for evaluation and requests for additional information was not fulfilled.The trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be determined.

• Brand Name: ADATO SIL-OL 5000 SILICONE OIL SYRINGE
• Common Device Name: FLUID, INTRAOCULAR
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): PHARMPUR GMBH; messerschmittring 33; konigsbrunn 86343 ; GM 86343
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 17091879
• Report Number: 0001313525-2023-70069
• Device Sequence Number: 2906119
• Product Code: LWL
• UDI-Device Identifier: 00757770516315
• UDI-Public: (01)00757770516315
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P910071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: AO60 IOL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male