Adato SIL-OL-5000 ES 5000 SRecalls & reported problems
Bausch & Lomb Incorporated · ADATO SIL-OL 5000 SYRINGE · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00757770516315), received between Jun 8, 2023 and Jun 8, 2023 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Loss of Vision1
- Retinal Detachment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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
Patient problems: Loss of Vision; Retinal Detachment
MAUDE report 17091879 ↗
Other Fluid, Intraocular devices
- SILIKON™ 8065601187Alcon Laboratories, Inc. · Fluid, Intraocular39 reports
- PERFLUORON 0090010015Alcon Laboratories, Inc. · Fluid, Intraocular2 deaths3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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