SILIKON™ 8065601187Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00380656011873), received between May 6, 2021 and Jun 15, 2026 — classified as 39 injuries.

The most frequently reported specific device problem is “Product Quality Problem” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2026Product Quality Problem

  A PHYSICIAN REPORTED THAT AFTER THE POST OPERATIVE THREE MONTHS OF VITRECTOMY SURGERY, THE TAMPONADE OIL IN THE PATIENT¿S RIGHT EYE WAS EMULSIFIED. THE SILICONE OIL WAS REMOVED FROM THE PATIENT¿S EYE. THE PATIENT WAS NOT HOSPITALIZED. THE PATIENT HAD INCREASED INTRAOCULAR PRESSURE. THE CURRENT OUTCOME OF THE PATIENT¿S CONDITION WAS UNKNOWN, THIS REPORT PERTAINS TO TWO OF THREE REPORTS FROM THE SAME FACILITY.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 25507065 ↗
• InjuryJun 11, 2026Product Quality Problem

  A PHYSICIAN REPORTED THAT AFTER THE POST OPERATIVE THREE MONTHS OF THE VITRECTOMY SURGERY, THE TAMPONADE OIL IN THE PATIENT RIGHT EYE WAS EMULSIFIED. THE SILICONE OIL WAS REMOVED FROM THE PATIENT EYE. THE PATIENT WAS NOT HOSPITALIZED. THERE WAS NO PATIENT HEALTH IMPACT REPORTED. THIS REPORT PERTAINS TO ONE OF THREE REPORTS FROM THE SAME FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 25471925 ↗
• InjurySep 11, 2025Break; Break

  A CUSTOMER REPORTED THAT ITEM CAME IN BROKEN, WHEN THE CIRCULATING NURSE ATTEMPTED TO TAKE THE PRODUCT OUT OF THE BOX HE HAD A CUT. PROCEDURE DETAILS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. NEW INFORMATION RECEIVED INDICATING THE VIAL APPEARED INTACT INSIDE OF THE PLASTIC BAG AND OIL WAS INSIDE THE BAG OUTSIDE OF THE VIAL. USER WOUND WAS WASHED AND DERMABOND ON THE CUT. CUT WAS HEALED. ANOTHER VIAL OF SILICONE OIL WAS OPENED AND USED FOR THE PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23025982 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT PATIENT EXPERIENCED SILIKON OIL TOXICITY WITH DIAGNOSIS OF CENTRAL VISION LOSS DUE TO AN INCREASE IN INFLAMMATORY AFFECTS TO THE OIL. THE PATIENT WAS TREATED WITH TOPICAL STEROID DROPS. HE STATED THERE HAS BEEN SLOW IMPROVEMENT WITH THE PATIENT BUT HIS VISION FLUCTUATES AND CONTINUES TO FOLLOW THE PATIENT. THIS COMPLAINT IS PERTAINING TO TWO OF THREE REPORTS RECEIVED FROM THE INITIAL REPORTER.

  Patient problems: Blurred Vision; Inflammation; Loss of Vision; Retinal Degeneration; Retinal Detachment; Toxic Anterior Segment Syndrome (TASS); Visual Impairment; Vitreous Hemorrhage

  MAUDE report 21967259 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM GOVERNMENT AGENCY INDICATED THAT PATIENT HAD A RECURRENT MACULA ON RETINAL DETACHMENT. HE UNDERWENT UNEVENTFUL VITRECTOMY WITH SILIKON OIL. THE BEST CORRECTED VISUAL ACUITY WAS REDUCED. IT WAS SUSPECTED TO REFRACTIVE ERROR INDUCED BY SILIKON OIL. SILIKON OIL WAS REMOVED. PATIENT REPORTED A SMALL CENTRAL SCOTOMA. THE BEST CORRECTED VISUAL ACUITY WAS REDUCED. PATIENT WAS DIAGNOSED AS SILIKON OIL TOXICITY. CURRENT CONDITION OF THE PATIENT REGARDING THE EVENT BEST CORRECTED VISUAL ACUITY WAS SYMPTOM CONTINUING, VITREOUS HEMORRHAGE, SCOTOMA, MACULAR THINNING, RETINAL DETACHMENT WAS UNKNOWN.

  Patient problems: Blurred Vision; Inflammation; Loss of Vision; Retinal Degeneration; Retinal Detachment; Visual Impairment

  MAUDE report 21941234 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM GOVERNMENT AGENCY INDICATED THAT PATIENT HAD A RECURRENT MACULA ON RETINAL DETACHMENT. HE UNDERWENT UNEVENTFUL VITRECTOMY WITH SILIKON OIL. BEST CORRECTED VISUAL ACUITY WAS REDUCED (BCVA) PRIOR TO SURGERY DUE TO A VITREOUS HEMORRHAGE, MACULA REMAINED ATTACHED. AFTER SILIKON OIL WAS REMOVED, BEST CORRECTED VISUAL ACUITY DID NOT IMPROVE. IT WAS SUSPECTED THAT INITIALLY DUE TO HIS CATARACT AND UNDERWENT UNEVENTFUL CATARACT SURGERY, BEST CORRECTED VISUAL ACUITY REMAINED POOR WITH A SMALL CENTRAL SCOTOMA. PATIENT WAS DIAGNOSED AS SILIKON OIL TOXICITY. CURRENT CONDITION OF THE PATIENT REGARDING THE EVENT VISION DECREASED WAS SYMPTOM CONTINUING, VITREOUS HEMORRHAGE, SCOTOMA, MACULAR THINNING, RETINAL DETACHMENT, TOXIC ANTERIOR SEGMENT SYNDROME WAS UNKNOWN.

  Patient problems: Blurred Vision; Inflammation; Loss of Vision; Retinal Degeneration; Retinal Detachment; Toxic Anterior Segment Syndrome (TASS); Visual Impairment; Vitreous Hemorrhage

  MAUDE report 21925718 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED RETINAL HEMORRHAGE AFTER COMBINATION OF CATARACT AND VITRECTOMY SURGERY. DETAILS OF PROCEDURE WAS NOT REPORTED.

  Patient problems: Retinal Hemorrhage

  MAUDE report 20339165 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED RETINAL HEMORRHAGE AFTER COMBINATION OF CATARACT AND VITRECTOMY SURGERY. DETAILS OF PROCEDURE WAS NOT REPORTED.

  Patient problems: Retinal Hemorrhage

  MAUDE report 20338707 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT A PATIENT, EXPERIENCED SYMPATHETIC OPHTHALMIA AFTER VITRECTOMY SURGERY DUE TO ENDOPHTHALMITIS. THE PATIENT RECEIVED STEROID PULSE THERAPY TO REDUCE THE SYMPTOMS.

  Patient problems: Uveitis

  MAUDE report 20188805 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LITERATURE ARTICLE REVEALED THAT AN OPHTHALMIC SILICONE OIL USED IN A VITRECTOMY SURGERY, SOMETIMES RESTORE IN THE RETINA MIGHT INCREASE IN INTRAOCULAR PRESSURE DUE TO EMULSIFICATION OF THE OIL IF IT REMAINS IN THE EYE FOR A LONG PERIOD OF TIME, IT WAS REMOVED A SHORT TIME AFTER SURGERY BUT IN SOME CASES IT MIGHT REMAIN AT THE BOTTOM OF THE CORNER ANGLE AND BE OBSERVED AS TRANSLUCENT GRANULES. PATIENTS WITH A LONG INTRAOCULAR LENS AND HIGH INTRAOCULAR PRESSURE BEFORE SILICONE OIL REMOVAL WERE MORE LIKELY TO HAVE MORE SILICONE OIL REMAINING, WHICH MIGHT LEAD TO AN INCREASE IN INTRAOCULAR PRESSURE, AND REQUIRE THOROUGH CLEANING.

  Patient problems: Foreign Body Sensation in Eye; Intraocular Pressure Increased

  MAUDE report 19709567 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LITERATURE ARTICLE REVEALED COMPLICATIONS OF AN OPHTHALMIC OIL INCLUDE INCREASED INTRAOCULAR PRESSURE, PUPILLARY BLOCK, EMULSIFICATION OF SILICONE OIL WHICH LEADS TO WHITE-COLORED FINE PARTICLES OCCLUDE THE ANGLE, RETINAL RE-DETACHMENT, CORNEAL ENDOTHELIAL DAMAGE.

  Patient problems: Corneal Clouding/Hazing; Corneal Endothelial Cell Loss; Intraocular Pressure Increased; Pupillary Block; Retinal Detachment

  MAUDE report 19528755 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LITERATURE RECEIVED STATED THAT A PATIENT WAS REFERRED TO HOSPITAL WITH DECREASED VISUAL ACUITY IN THE RIGHT EYE AND HAD INFLAMMATION IN THE ANTERIOR CHAMBER AND CILIARY INJECTION. THE FUNDUS SHOWED VITREOUS OPACITY AND A PROMINENT WHITE EXUDATIVE SPOT WAS SEEN IN THE PERIRETINAL AREA SUSPECT­ING ENDOGENOUS ENDOPHTHALMITIS. THE PATIENT UNDERWENT VITRECTOMY WITH OPHTHALMIC TAMPONADE, POST SYSTEMIC TREATMENT WITH ANTIVIRAL AND CORTICOSTEROID MEDICATION, THE BEST CORRECTED VISUAL ACTIVITY (BCVA) IN THE RIGHT EYE IMPROVED POST­ OPERATIVELY, BUT SUDDENLY DECREASED WITH CENTRAL SCOTOMA AT 4 MONTHS POSTOPERATIVELY. OPTICAL COHERENCE TOMOGRAPHY REVEALED A LOSS OF THE NERVE FIBER LAYER AND MARKED THINNING OF THE GANGLION CELL LAYER AND INNER RETINAL LAYER IN THE PARACENTRAL FOSSA OF THE RIGHT EYE LEADING TO VISUAL LOSS DUE TO RETINAL TOXICITY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Retinal Injury; Visual Impairment

  MAUDE report 17604606 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Blurred Vision; Cataract; Loss of Vision; Retinal Degeneration

  MAUDE report 17265397 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 IWR, AND THE USE OF INTRAOCULAR TAMPONADE. THE SIXTH PATIENT IN THE STUDY UNDERWENT A COMBINATION OF LENS-SPARING VITRECTOMY, INNER WALL RETINECTOMY USING OPHTHALMIC TAMPONADE , THE PATIENT REQUIRED AN ADDITIONAL SURGERY FOR THE REMOVAL OF SILICON OIL TAMPONADE. THIS IS ONE OF SIX REPORTS FOR THE SIXTH PATIENT (OD) INVOLVED IN THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16929957 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 IWR, AND THE USE OF INTRAOCULAR TAMPONADE. THE SIXTH PATIENT IN THE STUDY UNDERWENT A COMBINATION OF PARS PLANA VITRECTOMY, PHACOEMULSIFICATION WITH AN INTRAOCULAR LENS IMPLANTATION, INNER WALL RETINECTOMY WITH OPHTHALMIC TAMPONADE, THE PATIENT REQUIRED AN ADDITIONAL SURGERY FOR THE REMOVAL OF OPHTHALMIC TAMPONADE. THIS IS ONE OF SIX REPORTS FOR THE SIXTH PATIENT (OS) INVOLVED IN THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16929850 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO COMPLICATION RELATED TO SILICONE OIL. SILICONE OIL WAS USED TO TREAT A COMPLICATION AFTER IT HAD DEVELOPED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Retinal Detachment

  MAUDE report 16929848 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 IWR, 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 AND UNRESOLVED RETINOSCHISIS IN LEFT 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 (OS) INVOLVED IN THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cataract; Retinal Detachment

  MAUDE report 16929664 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 IWR, AND THE USE OF INTRAOCULAR TAMPONADE. THE NINETH PATIENT IN THE STUDY UNDERWENT VITRECTOMY WITH THE HELP OF OPHTHALMIC TAMPONADE AND DURING THE FOLLOW UP IT WAS FOUND THAT THE PATIENT HAD UNRESOLVED RETINOSCHISIS IN LEFT EYE. ADDITIONAL SURGERIES SUCH AS LENS-SPARING VITRECTOMY (LSV), INNER WALL RETINECTOMY (IWR), GAS APPLICATION AND OPHTHALMIC TAMPONADE REMOVAL HAS BEEN PERFORMED. THE PATIENT EYE HAD MAINTAINED A CLEAR CENTRAL VISUAL AXIS AT THE LAST EXAMINATION. THIS IS ONE OF SIX REPORTS FOR THE PATIENT NINE (OS) INVOLVED IN THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Retinal Detachment

  MAUDE report 16929283 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Cataract

  MAUDE report 16928956 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16830780 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED AFTER THE PATIENT UNDERWENT OPHTHALMIC SURGERY, THE PATIENT DEVELOPED ACUTE PULMONARY EDEMA THAT SAY DAY NIGHT AND WAS TRANSFERRED TO HOSPITAL. THE PATIENT WAS IN A STATE OF USING EXTRACORPOREAL MEMBRANE OXYGENATION TEMPORARILY, BUT NOW THAT THE PATIENT¿S CONDITION HAD CALMED DOWN AND WAS RETURNED FROM THE HOSPITAL.

  Patient problems: Pulmonary Edema

  MAUDE report 16370222 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LITERATURE ARTICLE REPORTED THAT AFTER USING AN OPHTHALMIC PRODUCT IN VITRECTOMY PROCEDURE A PATIENT WITH A PAST OCULAR HISTORY HAS EXPERIENCED INCREASE IN INTRA OCULAR PRESSURE. PATIENT HAS ALSO DEVELOPED INTERVAL LOSS OF ALL LIGHT PERCEPTION AND PAIN IN RIGHT EYE AND IT WAS NOTED THAT THE RIGHT EYE ANTERIOR CHAMBER WAS FOUND TO BE COMPLETELY FILLED WITH THE OPHTHALMIC OIL. HENCE THE PATIENT UNDERWENT PARS PLANA VITRECTOMY WITH REMOVAL OF THE OPHTHALMIC PRODUCT. IT WAS ALSO NOTED THAT PATIENT HAD DEVELOPED CENTRAL AND TEMPORAL VISION LOSS OF VISION IN LEFT EYE AND AUTOMATED VISUAL FIELD TESTING DEMONSTRATED A NEW TEMPORAL FIELD DEFECT LEFT EYE. MRI OF THE BRAIN AND ORBITS DEMONSTRATED MILD PRECONTRAST T1-HYPERINTENSITY AND MILD T2-HYPERINTENSITY OF THE RIGHT OPTIC NERVE AND A LONG WITH T1-HYPERINTENSITIES IN THE BIFRONTAL HORNS OF THE LATERAL VENTRICLES. POSTCONTRAST IMAGES DEMONSTRATED PROMINENT SUPPRESSION OF SIGNAL (HYPOINTENSITY) EXTENDING FROM THE RETROBULBAR RIGHT OPTIC NERVE TO THE CHIASM AND ENHANCEMENT OF THE RIGHT ORBITAL NERVE SHEATH. THE PATIENT WAS PRESCRIBED WITH TOPICAL GLAUCOMA DROPS, HIGH-DOSE INTRAVENOUS AND ORAL CORTICOSTEROIDS. ALSO, PATIENT HAD UNDERWENT OPT

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased; Loss of Vision

  MAUDE report 16330720 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LITERATURE ARTICLE REPORTED THAT AFTER USING AN OPHTHALMIC PRODUCT IN VITRECTOMY PROCEDURE A PATIENT WITH A PAST OCULAR HISTORY HAS EXPERIENCED INCREASE IN INTRA OCULAR PRESSURE. PATIENT HAS ALSO DEVELOPED INTERVAL LOSS OF ALL LIGHT PERCEPTION AND PAIN IN RIGHT EYE AND IT WAS NOTED THAT THE RIGHT EYE ANTERIOR CHAMBER WAS FOUND TO BE COMPLETELY FILLED WITH THE OPHTHALMIC OIL. HENCE THE PATIENT UNDERWENT 23-GAUGE PARS PLANA VITRECTOMY WITH REMOVAL OF THE OPHTHALMIC PRODUCT. IT WAS ALSO NOTED THAT PATIENT HAD DEVELOPED CENTRAL AND TEMPORAL VISION LOSS OF VISION IN LEFT EYE AND AUTOMATED VISUAL FIELD TESTING DEMONSTRATED A NEW TEMPORAL FIELD DEFECT LEFT EYE. MRI OF THE BRAIN AND ORBITS DEMONSTRATED MILD PRECONTRAST T1-HYPERINTENSITY AND MILD T2-HYPERINTENSITY OF THE RIGHT OPTIC NERVE AND A LONG WITH T1-HYPERINTENSITIES IN THE BIFRONTAL HORNS OF THE LATERAL VENTRICLES. POSTCONTRAST IMAGES DEMONSTRATED PROMINENT SUPPRESSION OF SIGNAL (HYPOINTENSITY) EXTENDING FROM THE RETROBULBAR RIGHT OPTIC NERVE TO THE CHIASM AND ENHANCEMENT OF THE RIGHT ORBITAL NERVE SHEATH. THE PATIENT WAS PRESCRIBED WITH TOPICAL GLAUCOMA DROPS, HIGH-DOSE INTRAVENOUS AND ORAL CORTICOSTEROIDS. ALSO, PATIENT HAD UNDE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Pain; Intraocular Pressure Increased; Loss of Vision

  MAUDE report 16323454 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LITERATURE ARTICLE REPORTED THAT A PATIENT UNDERWENT CATARACT SURGERY AND VITRECTOMY WITH CYCLOPLEGIC SURGERY WITH OPHTHALMIC PRODUCT FOR LEFT RHEGMATOGENOUS RETINAL DETACHMENT. PATIENTS EYE PRESSURE WAS STABLE UNDER GLAUCOMA EYE DROPS. TWO YEARS LATER PATIENT UNDERWENT VITRECTOMY TO REMOVE OPHTHALMIC PRODUCT HOWEVER THE INTRAOCULAR PRESSURE (IOP) GRADUALLY INCREASED AFTER SURGERY. IOP RISE WAS TREATED WITH GLAUCOMA EYE DROPS AND CARBONIC ANHYDRASE MEDICATION, ALSO ANTERIOR CHAMBER WASH OUT WAS DONE IN TWO MONTHS AND LASER TRABECULOPLASTY WAS PERFORMED IN THREE MONTHS. HOWEVER, THE IOP DID NOT DECREASE SUFFICIENTLY, AND A TRABECULOTOMY WITH REMOVAL OF RESIDUAL SILICONE OIL WAS PERFORMED. AFTER TRABECULOTOMY PATIENT INTRAOCULAR PRESSURE DID NOT INCREASE AND REMAINED STABLE UNDER GLAUCOMA EYE DROPS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Decreased

  MAUDE report 16290748 ↗
• InjuryDec 7, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT POSTOPERATIVELY AN OPHTHALMIC OIL WAS USED IN A VITRECTOMY PROCEDURE AND THE OIL WAS INVADED TO THE UPPER CHOROIDAL CAVITY AND REQUIRED EXTENSIVE RETINOCHOROIDAL EXCISION AND RESTORATION OF THE POSTERIOR POLE AND SUPERIOR RETINA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15930550 ↗