Bausch + Lomb SimplifEYE for enVistaRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00757770571758), received between Sep 29, 2022 and Sep 17, 2026 — classified as 36 injuries.

The most frequently reported specific device problem is “Break” (4 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. 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  A legal protection agency reported that during implantation of an intraocular lens (IOL) into the left eye, , a tear occurred at the inferotemporal edge of the capsulorhexis; the IOL was therefore repositioned in the sulcus. The procedure was closed with buried corneal sutures and intracameral Aprokam (cefuroxime). Approximately 10 days post procedure, the implanted IOL subluxated inferotemporally. An IOL exchange under general anesthesia was proposed and scheduled for approximately two months post procedure, however the patient declined further surgery. At follow-up visit 1 year and 4 months post procedure, the left eye showed a subluxated IOL in the inferotemporal quadrant, superior corneal scar from 10 to 2 o'clock with four sutures in place, best corrected visual acuity 4/10 fluctuating (10/10 right eye) and IOP 22 mmHg; fundus and macular OCT normal, no corneal or macular oedema, no infection.

  Patient problems: Insufficient Information

  MAUDE report 50809511 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  A legal protection agency reported that during implantation of an intraocular lens (IOL) into the capsular bag of the left eye, the surgeon observed extensive scratches of the optic surface. The operative report and discharge letter attribute the damage to contact between the injector plunger and the lens optic during injection. Consequently, there was an enlargement of the corneal incision, explantation of the damaged IOL, and implantation of a second IOL of the same model.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808592 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE FACILITY REPORTED THAT DURING AN IMPLANTATION OF AN INTRAOCULAR LENS (IOL) ONE OF THE HAPTICS TORE OFF. THE LENS WAS REMOVED AND THE BACKUP IOL WAS IMPLANTED. THE PATIENT IS SEVERELY HYPEROPIC AND HAS A VERY NARROW ANTERIOR CHAMBER, MAKING MANIPULATION DIFFICULT FROM THE POINT OF VIEW OF THE CORNEAL ENDOTHELIUM, AND THE REMOVAL OF THE DEFECTIVE IMPLANT PROMOTED AN IRIS HERNIA. THIS REQUIRED ADDITIONAL SEDATION (PROPOFOL) FOR PATIENT PAIN AND INCREASED THE OPERATING TIME BY ABOUT 15 MINUTES (ENLARGEMENT OF THE MAIN INCISION, CUTTING WITH OFFSET SCISSORS, REMOVAL OF THE SEGMENTED IOL, REINJECTION OF THE BACKUP IOL, REINTEGRATION OF THE IRIS, INJECTION OF MIOSTAT (CARBACHOL), AND PLACEMENT OF A SUTURE). THE SURGEON DOESN¿T THINK THERE WILL BE ANY CONSEQUENCES IN TERMS OF VISUAL ACUITY. THE AFTER-EFFECTS SHOULD BE LIMITED TO AN IRIS SCAR, WHICH IS USUALLY ASYMPTOMATIC.

  Patient problems: Eye Pain; Hernia

  MAUDE report 24776696 ↗
• InjuryDec 8, 2025Break; Break

  IT WAS REPORTED THAT DURING IMPLANTATION AN ADVERSE EVENT OCCURRED DURING SURGERY WHERE THE TIP OF AN ENVISTA INJECTOR SNAPPED INSIDE THE PATIENT¿S EYE. THE PATIENT REQUIRED AN ENLARGED INCISION (ABOUT 3.5 MM) AND REMOVAL OF THE FOREIGN BODY, FOLLOWED BY TWO STITCHES. THE ORIGINAL LENS REMAINED IN PLACE PRIOR TO THE INJECTOR TIP SNAPPING OFF, SO THAT LENS STAYED IN THE EYE. THE SURGEON'S OPINION ATTRIBUTES THE ISSUE TO THE ENVISTA INJECTOR. THE PATIENT HAS RECOVERED.

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

  MAUDE report 23742803 ↗
• InjuryOct 15, 2025Crack; Adverse Event Without Identified Device or Use Problem; Crack; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) A CRACK WAS NOTICED IN THE OPTIC OF THE LENS. THE LENS WAS REMOVED AND RESULTED IN AN IRIS PROLAPSE. THE SURGERY WAS EXTENDED BY 30 MINUTES WITH A BACK UP LENS IMPLANTED AND 3 STITCHES BEING PLACED. DUE TO THE COMPLICATION THE PATIENT HAD TO RETURN TO HAVE AN OZURDEX PLACED AT A LATER TIME.

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

  MAUDE report 23302877 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL REPORTED THAT ON DAY 2, FOLLOWING AN UNCOMPLICATED INTRAOCULAR LENS (IOL) IMPLANTATION THE PATIENT PRESENTED WITH CORNEAL EDEMA. THE EDEMA WAS TREATED WITH DEXAFREE (DEXAMÉTHASON) EYE DROP, INDOCOLLYRE (INDOMETACIN), ODM5 (SODIUM HYALURONATE) EYE DROPS AND GELTIM (TIMOLOL) VIA OCULAR ROUTE. A BROKEN HAPTIC WAS DISCOVERED IN THE ANTERIOR CHAMBER. APPROXIMATELY 11 WEEKS POST IMPLANTATION THE PATIENT WAS REHOSPITALIZED AND A DIFFERENT SURGEON EXPLANTED THE ORIGINAL IOL, REMOVED THE BROKEN HAPTIC AND ANOTHER LENS WAS PLACED IN THE EYE. BEFORE THE ORIGINAL SURGERY, THE VA WAS 5F/10 P5. TWO DAYS POST-SURGERY THE VA WAS: 3/10 P6. THE VA WAS NOT QUANTIFIABLE AT ONE-MONTH POST-SURGERY. NO VA AVAILABLE POST REVISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Corneal Edema

  MAUDE report 22508272 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL REPORTED THAT SCRATCHES WERE NOTICED ON THE INTRAOCULAR LENS (IOL) AFTER IT WAS IMPLANTED IN THE EYE. THE IOL WAS REMOVED INTRAOPERATIVELY AND REPLACED WITH ANOTHER LENS OF THE SAME POWER. THE INCISION WAS ENLARGED TO REMOVE THE IOL AND A SUTURE WAS REQUIRED. AS A RESULT OF THE INCREASED DURATION OF THE SURGERY, AN ADDITIONAL INTRACAMERAL LOCAL ANESTHETIC WAS NECESSARY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT AND THE PATIENT 'S CURRENT CONDITION IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383163 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL REPORTED THAT ON DAY 3, FOLLOWING AN UNCOMPLICATED IOL IMPLANTATION THE PATIENT PRESENTED WITH NORMAL VISION AND SATISFACTORY PARAMETERS. THE PATIENT RETURNED ON DAY 5, DUE TO EXPERIENCING VISUAL DISTURBANCES AND REDUCED VISION, THEY WERE REFERRED TO A RETINAL SURGEON. THE RETINAL SURGEON DISCOVERED AN ABNORMAL TRACE DURING THE ULTRASOUND EXAMINATION. AS THE PATIENT'S VISION WORSENED, A SECOND SURGERY WAS PERFORMED TO REPLACE THE IOL. THE ORIGINAL IOL WAS EXPLANTED AND A NEW MONOFOCAL LENS WAS PLACED IN THE EYE. THE ORIGINAL LENS WAS DETERMINED TO BE DECENTRALIZED IMPLANT SUPERIORLY AND THE HAPTIC WAS BROKEN IN THE ANTERIOR CHAMBER. SIX DAYS POST REVISION VA WAS 8/10 WITH SIGNIFICANT ASTIGMATISM, CORNEAL EDEMA, AND SUTURE IN PLACE. TWELVE DAYS POST REVISION VA WAS 10/10 WITH SIGNIFICANT ASTIGMATISM, REDUCED CORNEAL EDEMA, AND SUTURE WAS REMOVED THAT DAY.

  Patient problems: Corneal Edema; Visual Disturbances; Visual Impairment

  MAUDE report 22294938 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL REPORTED THAT DURING AN IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE PATIENT EYE THE LEADING HAPTIC WAS STRAIGHT AND RUPTURED THE CAPSULAR BAG. THE IOL WAS REMOVED INTRAOPERATIVELY; AN ANTERIOR VITRECTOMY WAS PERFORMED, AND DIFFERENT MODEL LENS WAS SUCCESSFULLY PLACED. PER THE REPORTER THE PATIENT HAD A GOOD VISUAL OUTCOME POST OPERATIVELY.

  Patient problems: Capsular Bag Tear

  MAUDE report 22178141 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE HAPTIC ON THE IOL BECAME STUCK AND BROKE. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND A STITCH WAS REQUIRED. A BACK UP LENS OF THE SAME MODEL AND DIOPTER WAS SUCCESSFULLY IMPLANTED. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21524865 ↗
• InjuryJan 9, 2025Adverse 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 RIGHT EYE, THE SURGEON NOTICED AN APPROXIMATELY 4MM CRACK IN THE LENS OPTIC STARTING NEAR THE OPTIC/HAPTIC JUNCTION AND EXTENDING TOWARDS THE CENTER OF THE LENS. THE IOL WAS REMOVED FROM THE EYE AND A SUCCESSFUL INTRAOPERATIVE LENS EXCHANGE WAS PERFORMED USING A BACKUP IOL OF THE SAME MODEL AND DIOPTER. A SUTURE WAS PLACED ACROSS THE MAIN INCISION TO CLOSE THE WOUND. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF EVENT IS THE DEFECTIVE LENS. PATIENT PROGNOSIS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112885 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL WAS UNABLE TO EJECT. SURGEON WAS UNABLE TO PROCEED WITHOUT AN IOL, THEREFORE, PATIENT WAS LEFT APHAKIC. PATIENT RETURNED FOUR DAYS LATER AND AN IOL OF THE SAME MODEL WAS SUCCESSFULLY IMPLANTED. THIS REPORT REFERENCES INJECTOR 1 OF 2. REFERENCE REPORT NUMBERS (B)(4).

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

  MAUDE report 19974217 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL WAS UNABLE TO EJECT. SURGEON WAS UNABLE TO PROCEED WITHOUT AN IOL, THEREFORE, PATIENT WAS LEFT APHAKIC. PATIENT RETURNED FOUR DAYS LATER AND AN IOL OF THE SAME MODEL WAS SUCCESSFULLY IMPLANTED. THIS REPORT REFERENCES INJECTOR 2 OF 2. REFERENCE REPORT NUMBERS 0001313525-2024-00141, 0001313525-2024-00142 AND 0001313525-2024-00143.

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

  MAUDE report 19974192 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER INSERTION OF AN INTRAOCULAR LENS (IOL) INTO THE PATIENT'S LEFT EYE, THE SURGEON NOTICED A HAPTIC WAS BROKEN AND REMAINED IN THE INJECTOR. THE INCISION WAS ENLARGED TO ALLOW FOR REMOVAL OF THE IOL AND A SUCCESSFUL INTRAOPERATIVE IOL EXCHANGE WAS PERFORMED USING A BACKUP IOL OF THE SAME MODEL AND DIOPTER. ONE CORNEAL SUTURE WAS USED TO CLOSE THE INCISION AND WAS REMOVED 8 DAYS POST-OP. PATIENT OUTCOME IS REPORTEDLY FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19942968 ↗
• InjuryJul 24, 2024Adverse 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 CAPSULAR BAG, THE IOL OPTIC CRACKED, CAUSING CAPSULE DAMAGE. THE IOL WAS REMOVED, A VITRECTOMY WAS PERFORMED, AND A 3-PIECE IOL WAS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.

  Patient problems: Capsular Bag Tear

  MAUDE report 19821498 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS THAT REPORTED DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE PATIENTS EYE THE SURGEON NOTICED THE OPTIC OF THE LENS WAS SCRATCHED. THE INCISION WAS ENLARGED TO ALLOW FOR REMOVAL OF THE IOL AND A SUCCESSFUL INTRAOPERATIVE LENS EXCHANGE WAS PERFORMED USING A BACKUP IOL. ONE SUTURE WAS USED TO CLOSE THE WOUND. PATIENT OUTCOME IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19578841 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE INCISION SIZE WAS ENLARGED TO 2.5MM, WHICH IS WITHIN STANDARD RANGE FOR INCISION ENLARGEMENT.

  Patient problems: Corneal Edema

  MAUDE report 19132853 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CATARACT SURGERY ONE OF THE HAPTICS ON AN INTRAOCULAR LENS WAS SEVERED. THE LENS WAS CUT AND REMOVED INTRAOPERATIVELY AND A REPLACEMENT LENS WAS IMPLANTED. REPORTEDLY, THE CORNEA DIDN'T LIKE THESE INTRAOCULAR MANOEUVRES AND THE PATIENT DEVELOPED POST-OP CORNEAL EDEMA. THE PATIENT WAS REFERRED TO ANOTHER HEALTHCARE FACILITY AND AN ENDOTHELIAL GRAFT WAS PERFORMED. THIS WORKED WELL AND THE PATIENT VISUAL ACUITY (VA) RECOVERED TO 10/10. ALTHOUGH REQUESTED ADDITIONAL INFORMATION WAS NOT OBTAINED.

  Patient problems: Corneal Edema

  MAUDE report 18736844 ↗
• InjuryFeb 19, 2024Ejection Problem; Ejection Problem

  REPORTEDLY, DURING IOL IMPLANT PROCEDURE THE INJECTOR PISTON OVERRODE THE LENS. THE INCISION WAS ENLARGED TO REMOVE THE IOL AND A BACK UP LENS OF AN UNKNOWN MODEL WAS IMPLANTED. A CORNEAL SUTURE WAS REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 18735495 ↗
• InjuryFeb 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SCRATCH WAS NOTICED ON AN INTRAOCULAR LENS (IOL) AFTER IT WAS INSERTED INTO THE PATIENT'S EYE. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED. SUTURES WERE REQUIRED TO CLOSE THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 18678445 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, A LEADING HAPTIC CAUSED A CAPSULAR TEAR DURING THE IMPLANTATION OF AN INTRAOCULAR LENS. THE LENS WAS REMOVED INTRAOPERATIVELY, AND A LENS OF A DIFFERENT MODEL WAS PLACED. THE INCISION WAS ENLARGED. THE PATIENT OUTCOME IS GOOD.

  Patient problems: Capsular Bag Tear

  MAUDE report 18318099 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, AN INTRAOCULAR LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY DUE TO A SCRATCH ON THE CENTER OF THE LENS. THE LENS WAS REPLACED WITH A LENS OF THE SAME MODEL AND DIFFERENT DIOPTER. THE INCISION WAS ENLARGED. THE PATIENT''S OUTCOME IS GOOD. ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641318 ↗
• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE EYE A HAPTIC ARM WAS STUCK TO THE LENS. DURING THE PROCESS OF RELEASING THE HAPTIC FROM THE LENS, THE HAPTIC TORE AT THE OPTIC-HAPTIC JUNCTION. THE INCISION WAS ENLARGED TO ALLOW FOR REMOVAL OF THE IOL AND THE LENS WAS REPLACED INTRAOPERATIVELY WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. SUTURES WERE NOT REQUIRED. THERE WERE NO INJURIES REPORTED. THE PATIENT HAS RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17437898 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON INSERTION OF AN INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S EYE THE OPTICAL PLATE OF THE LENS WAS NOT INTACT. THE LENS WAS REMOVED AND ANOTHER LENS WAS IMPLANTED. THE SURGICAL TIME WAS EXTENDED AND A SUTURE WAS PLACED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17425636 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON INSERTION OF AN INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S EYE THE IOL HAPTIC WAS BROKEN. THE LENS WAS CUT AND THE INCISION WAS ENLARGED TO REMOVE THE LENS. ANOTHER LENS WAS SUCCESSFULLY IMPLANTED. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17386861 ↗