BLIS-X1Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00757770520183), received between Feb 23, 2023 and Jun 18, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Ejection 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 2 DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE, THE PATIENT PRESENTED WITH HYPOPYON AND VITRITIS. BASED ON THE FINDINGS, THE SURGEON CONCLUDED THE CAUSE AS ENDOPHTHALMITIS. IN THE IMPLANTING SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT COULD NOT BE DETERMINED. MEDICATION ADMINISTERED DURING ORIGINAL SURGERY: INTRACAMERAL MOXIFLOXACIN. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: PREDNISOLONE 1%: 1 GTT QID X 2 WEEKS, THEN TID X 2 WEEKS (TOTAL DURATION: 1 MONTH) OFLOXACIN 0.3%: 1 GTT QID X 7 DAYS KETOROLAC 0.5%: 1 GTT QID X 2 WEEKS, THEN TID X 2 WEEKS. (TOTAL DURATION: 1 MONTH)

  Patient problems: Endophthalmitis; Hypopyon

  MAUDE report 25551649 ↗
• InjuryJun 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 6 DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD) THE PATIENT PRESENTED WITH CLINICAL FINDINGS CONSISTENT WITH ACUTE ENDOPHTHALMITIS ACCOMPANIED BY A DECREASE IN VISUAL ACUITY FROM COUNTING FINGERS AT 4 FEET TO HAND MOTION. THE PATIENT WAS REFERRED THE SAME DAY TO A RETINA SPECIALIST, WHO PERFORMED A CULTURE AND ADMINISTERED AN INTRAOCULAR INJECTION. THE CULTURE SHOWED NO GROWTH. APPROXIMATELY EIGHT WEEKS LATER, THE PATIENT UNDERWENT A PARS PLANA VITRECTOMY TO ADDRESS A POSTERIOR VITREOUS DETACHMENT (PVD). AT THE POSTOPERATIVE VISIT THE FOLLOWING DAY, THE RETINA SPECIALIST DOCUMENTED: RESOLVED ACUTE ENDOPHTHALMITIS WITH STRUCTURALLY STABLE FINDINGS, CENTRAL RETINAL VEIN OCCLUSION WITH MACULAR EDEMA OD, EPIRETINAL MEMBRANE IN BOTH EYES (OU), RESOLVED PVD OD, AND PVD LEFT EYE (OS). IN THE IMPLANTING SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE MOST RECENT RECORDED VISUAL ACUITY FOR THE AFFECTED EYE WAS NO LIGHT PERCEPTION (NLP). THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: PREDNISOLONE 1%: 1 GTT QID X 2 WEEKS, THEN TID X 2 WEEKS (TOTAL DURATION: 1 MONTH), OFLOXACIN 0.3

  Patient problems: Endophthalmitis; Macular Edema; Visual Impairment; Vitreous Detachment

  MAUDE report 25550902 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE HAPTIC WAS TORN. THE INCISION WAS ENLARGED AND A DIFFERENT MODEL IOL WAS IMPLANTED. A SUTURE WAS USED TO HELP CLOSE THE WOUND. POST-OPERATIVELY THE PATIENT WAS DIAGNOSED WITH CORNEAL EDEMA AND INFLAMMATION, HOWEVER ACCORDING TO THE SURGEON THE PATIENT IS IMPROVING. IN THE SURGEON¿S OPINION THE MOST LIKELY CAUSE OF THE EVENT IS THE MANNER LENS WAS LOADED INTO THE CARTRIDGE BY THE SCRUB TECH.

  Patient problems: Corneal Edema; Inflammation

  MAUDE report 25368663 ↗
• InjuryMay 29, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD), THE LENS SUBSEQUENTLY DISLOCATED. APPROXIMATELY SIX WEEKS AFTER ONSET OF THE ISSUE, THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE DISLOCATION WAS CAPSULE DAMAGE. IT IS NOT CLEAR WHEN THE CAPSULE DAMAGE HAPPENED. THE PATIENT¿S OUTCOME IS GOOD.

  Patient problems: Capsular Bag Tear; Visual Impairment

  MAUDE report 25330467 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE FACILITY REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED AFTER ACCIDENTAL RUPTURE OF THE POSTERIOR CAPSULE FOLLOWING ASPIRATION OF THE CRYSTALLINE LENS CORTEX. WHEN THE LENS WAS INJECTED INTO THE EYE IT WAS NOTED THAT THERE WAS A CUT AT THE EDGE OF THE LENS OPTIC AND A HAPTIC WAS MISSING. THE INCISION WAS ENLARGED FOR REMOVAL OF THE LENS, AND SEVERAL CORNEAL SUTURES WERE USED TO CLOSE THE INCISION. AS A SUITABLE LENS WAS NOT AVAILABLE THE PATIENT WAS LEFT APHAKIA.

  Patient problems: Insufficient Information

  MAUDE report 25057701 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT 1 DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS) OF A PATIENT ENDOPHTHALMITIS OCCURRED IN THE OPERATED EYE. AT THE ONE-DAY POST OP SLIT LAMP FINDINGS THE SURGEON NOTED HYPOPYON, AC CELLS AND FLARE, A DECREASE IN PATIENTS BCVA. INITIAL TREATMENT CONSISTED OF TOPICAL MOXIFLOXACIN AND PREDNISONE ACETATE. TWO DAYS AFTER THE INITIAL PROCEDURE THE PATIENT HAD AN ELEVATED IOP OF 36MMHG. THREE DAYS AFTER THE LENS WAS INITIALLY PLACED A VITRECTOMY WAS PERFORMED. CULTURE AND SENSITIVITY PERFORMED WAS POSITIVE FOR ENTEROCOCCUS FAECALIS. INTRAOCULAR INJECTIONS WITH AN UNSPECIFIED MEDICATION WERE ADMINISTERED FOR ENDOPHTHALMITIS TREATMENT ON POSTOPERATIVE DAY 5 AND POSTOPERATIVE DAY 7 FOLLOWING THE ORIGINAL IOL PLACEMENT. AT THE TIME OF REPORTING, THE PATIENT¿S PROGNOSIS AND ONGOING TREATMENT COURSE WERE DESCRIBED AS GOOD.

  Patient problems: Endophthalmitis; Hypopyon; Intraocular Pressure Increased; Visual Impairment

  MAUDE report 24780426 ↗
• InjuryMar 25, 2026Failure to Eject

  DURING INSERTION OF THE INTRAOCULAR LENS (IOL), THE TRAILING HAPTIC CAUGHT IN THE CARTRIDGE AS IT WAS BEING ADVANCED. THE HAPTIC WAS FREED AND THE LENS WAS SUBSEQUENTLY IMPLANTED IN THE PATIENT¿S EYE. THE HAPTIC WAS FOUND TO BE CRACKED AND DISLOCATED FROM THE CAPSULAR BAG, MIGRATING INTO THE SULCUS. TWO WEEKS POST IMPLANT THE HAPTIC WAS REPOSITIONED BACK INTO THE CAPSULAR BAG. THE LENS REMAINS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 24685646 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  A SURGERY CENTER REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE HAPTIC CAME OFF THE LENS. THE LENS WAS CUT OUT AND REMOVED FROM THE PATIENT, LEAVING THEM APHAKIC. AN IOL OF THE SAME MODEL AND DIOPTER WAS IMPLANTED THREE DAYS LATER AT A DIFFERENT FACILITY. THE PATIENT HAS FULLY RECOVERED WITHOUT COMPLICATIONS.

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

  MAUDE report 24517643 ↗
• InjuryJul 11, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE LENS UNFOLDED TOO QUICKLY CAUSING ZONULAR DAMAGE AND IOL DECENTRATION. THE INCISION WAS ENLARGED TO ALLOW FOR REMOVAL OF THE LENS, A DIFFERENT MODEL IOL WAS IMPLANTED INTO THE SULCUS, AND THE INCISION WAS CLOSED WITH SUTURES. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS QUICK UNFOLD OF LENS AFTER IMPLANT. PATIENT OUTCOME IS GOOD.

  Patient problems: Zonular Dehiscence

  MAUDE report 22478155 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, SURGEON NOTICED LEADING HAPTIC CAUSED POSTERIOR CAPSULE (PC) RUPTURE AND VITREOUS PROLAPSE. THE LENS WAS REMOVED INTRAOPERATIVELY, AN ANTERIOR VITRECTOMY WAS PERFORMED, AND A DIFFERENT MODEL IOL WAS IMPLANTED INTO THE SULCUS. PATIENT REPORTEDLY DOING OKAY. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Capsular Bag Tear; Ventricular Tachycardia; Vitreous Loss

  MAUDE report 22038599 ↗
• InjuryApr 30, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE INCISION SIZE WAS WELL WITHIN THE STANDARD SURGERY PROTOCOL.

  Patient problems: Insufficient Information

  MAUDE report 21935210 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE FIBROUS MEMBRANE WAS ON THE ANTERIOR OPTIC OF THE LENS. THE PATIENT IS RECOVERING.

  Patient problems: Toxic Anterior Segment Syndrome (TASS); Visual Impairment

  MAUDE report 21463098 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE FACILITY IN NORWAY REPORTED THAT FOLLOWING AN UNCOMPLICATED CATARACT SURGERY, IN THE LEFT EYE THE PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT EXPERIENCED EYE PAIN AND INFLAMMATION IN THE ANTERIOR CHAMBER WITH SUSPECTED BACTERIAL ENDOPHTHALMITIS. A VITRECTOMY WAS PERFORMED AND CULTURED WITH NEGATIVE RESULTS. THE PATIENT PROGNOSIS IS REPORTEDLY GOOD WITH ONGOING LOW GRADE ANTERIOR CHAMBER INFLAMMATION.

  Patient problems: Eye Pain; Inflammation; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 20925022 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, A TORIC IOL WAS REMOVED AND REPLACED WITH A NON-TORIC IOL DUE TO ALLEGED IOL DEFECT AT THE EDGE OF THE OPTIC. THE INCISION WAS ENLARGED TO ALLOW FOR REMOVAL OF THE IOL AND A SUCCESSFUL INTRAOPERATIVE LENS EXCHANGE WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20637950 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE ONE-DAY POST-OPERATIVE VISIT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE SURGEON NOTED THE PATIENT PRESENTED WITH 1-2+ EDEMA, SEIDEL SIGN, AND CELL 2+ FIBRIN IN AC. THIS REACTION WAS DIAGNOSED AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT'S BCVA DECREASED FROM 20/150 TO CF @ 1 FT. THE DAY AFTER SYMPTOMS WERE OBSERVED, AN INTRAVITREAL INJECTION OF VANCOMYCIN & CEFTAZIDIME WAS PERFORMED, AND A CULTURE WAS TAKEN. THE RESULT OF THE CULTURE WAS NEGATIVE. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF EVENT IS POSSIBLY FROM THE VISCO AND LIDO/PHEN. PATIENT OUTCOME IS GOOD. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POSTOPERATIVELY: PRED-MOXI-BROM 1%, .5%, 0.075% DOSE: 1GTT FREQUENCY: TID 2 WEEKS, BID 1 WEEK, QD 1 WEEK NEOMYCIN & POLYMYXIN & DEXAMETHASONE DOSE: 1 SMALL RIBBON FREQUENCY: ONCE. PREDNISOLONE 1% DOSE:1GTT FREQUENCY: QHOURLY DURATION: UNTIL DIRECTED OTHERWISE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Vision; Swelling/ Edema; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19940649 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE ONE-DAY POST-OPERATIVE VISIT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE SURGEON NOTED THE PATIENT PRESENTED WITH 1+ EDEMA, 4+ FIBRIN, AND TRACE SLIVER OF HYPOPYON. THIS REACTION WAS DIAGNOSED AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF EVENT IS POSSIBLY FROM THE VISCO AND LIDO/PHEN. PATIENT OUTCOME IS GOOD. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POSTOPERATIVELY: NEOMYCIN & POLYMYXIN & DEXAMETHASONE DOSE: 1 SMALL RIBBON FREQUENCY: ONCE PRED-MOXI-BROM 1%, .5%, 0.075% DOSE: 1GTT FREQUENCY: TID 2 WEEKS, BID 1 WEEK, QD 1 WEEK DUREZOL DOSE: 1GTT FREQUENCY: QHOURLY DURATION: TILL DIRECTED OTHERWISE MOXIFLOXACIN DOSE: 1GTT FREQUENCY: QHOURLY DURATION: TILL DIRECTED OTHERWISE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypopyon; Loss of Vision; Swelling/ Edema; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19940125 ↗
• InjuryMay 24, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT UPON DELIVERY OF AN INTRAOCULAR LENS (IOL) INTO THE EYE, THE SURGEON NOTICED THE HAPTIC WAS DAMAGED. UNDER MICROSCOPIC EXAMINATION, THE SURGEON DISCOVERED THE VERY TIP OF TRAILING HAPTIC WAS MISSING AND NOT IN THE EYE, IT WAS IN THE INJECTOR CARTRIDGE. THE INCISION WAS ENLARGED TO ALLOW FOR REMOVAL OF THE IOL AND A SUCCESSFUL INTRAOPERATIVE LENS EXCHANGE WAS PERFORMED USING A BACKUP IOL OF THE SAME MODEL AND DIOPTER. PATIENT OUTCOME IS GOOD. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392467 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING AN ANTERIOR CAPSULAR TEAR OCCURRED PRIOR TO INSERTION OF THE INTRAOCULAR LENS.

  Patient problems: Insufficient Information

  MAUDE report 19167250 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER INSERTING AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE AND ADJUSTING TO THE PROPER ROTATION, A POSSIBLE PERIPHERAL POSTERIOR CAPSULE TEAR WAS NOTED NASALLY. THE IOL WAS REMOVED, THE INCISION WAS ENLARGED TO ALLOW FOR A DIFFERENT MODEL IOL, AND A 3-PIECE IOL WAS IMPLANTED POSITIONED IN THE SULCUS WITH POSTERIOR OPTIC CAPTURE. A SUTURE WAS USED TO CLOSE WOUND. THE PATIENT RECOVERED.

  Patient problems: Capsular Bag Tear

  MAUDE report 18920449 ↗
• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INSERTION OF AN IOL, INTO THE EYE, A PORTION OF THE IOL HAPTIC/OPTIC JUNCTION WAS BROKEN. THE SURGEON MADE THE DECISION TO LEAVE THE IOL IN THE EYE, BECAUSE IT SEEMED STABLE. APPROXIMATELY A WEEK AFTER THE IMPLANTATION, THERE WAS A FORTY-DEGREE ROTATION OF THE IOL. THE IOL WAS EXPLANTED AND REPLACED WITH A LENS OF THE SAME MODEL AND DIOPTER, 2 WEEKS POST-IMPLANTATION. IN THE SURGEON'S OPINION, THE PARTIALLY BROKEN OPTIC/HAPTIC JUNCTION MAY HAVE CAUSED THE IOL ROTATION. THE PATIENT OUTCOME IS GOOD.

  Patient problems: Insufficient Information

  MAUDE report 18584228 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE CAPSULAR BAG COLLAPSED WHEN THE LENS WAS PLACED INTO THE EYE. THE IOL WAS REMOVED, AND A BACKUP LENS OF A DIFFERENT MODEL WAS SUCCESSFULLY IMPLANTED. THE PATIENT OUTCOME IS GOOD.

  Patient problems: Capsular Bag Tear

  MAUDE report 18368276 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE POSTERIOR CAPSULE RUPTURED. THE IOL WAS REMOVED, A VITRECTOMY WAS PERFORMED, AND A SUCCESSFUL LENS EXCHANGE WAS PERFORMED USING A DIFFERENT MODEL IOL POSITIONING THE LENS IN THE CILIARY SULCUS. A SUTURE WAS USED TO CLOSE WOUND. PER THE SURGEON, THE LIKELY CAUSE OF EVENT IS LEADING HAPTIC OR OPTIC CATCHING THE BAG, TEARING IT. PATIENT OUTCOME IS GOOD.

  Patient problems: Capsular Bag Tear

  MAUDE report 18278861 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, A POSTERIOR CAPSULE TEAR WAS OBSERVED DURING IMPLANT. THE IOL WAS REMOVED AND A THREE PIECE LENS WAS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Capsular Bag Tear

  MAUDE report 16428190 ↗