Bausch + Lomb BLIS-R1Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00757770520176), received between Apr 23, 2024 and May 1, 2026 — classified as 7 injuries.

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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 25057702 ↗
• 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 24780120 ↗
• 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 21463097 ↗
• 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 20925051 ↗
• 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 19940684 ↗
• 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 19940162 ↗
• 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 19167385 ↗