Bausch + Lomb EZ-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00757770520022), received between Jan 22, 2020 and Sep 29, 2026 — classified as 15 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (5 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 16, 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.

• MalfunctionSep 29, 2026Material Split, Cut or Torn

  It was reported that during insertion of an intraocular lens (IOL) into the left eye (OS), the surgeon heard a cracking sound from the injector, and the lens exited through the side of the injector rather than the tip. The injector containing the IOL was withdrawn from the eye, and a backup lens was implanted. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933516 ↗
• MalfunctionApr 15, 2026Crack

  AN EYE SURGERY CENTER REPORTED THAT DURING INSERTION OF AN INTRAOCULAR LENS (IOL) THE TIP OF THE INJECTOR CRACKED AND THE LENS WENT OUT THE SIDE. THERE WAS NO INJURY TO THE PATIENT AND A BACKUP LENS WAS SUCCESSFULLY IMPLANTED WITH NO NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885170 ↗
• MalfunctionJan 15, 2026Crack

  AN EYE SURGERY CENTER REPORTED THAT DURING INSERTION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE THE NOSE OF THE INJECTOR WAS NOTED TO BE SPLIT WHEN THE SURGEON INSERTED IT INTO THE EYE AND STARTED TO ADVANCE THE LENS. THE SAME LENS WAS RELOADED INTO A NEW INJECTOR AND SUCCESSFULLY IMPLANTED WITH NO NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24081219 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT WAS REFERRED TO A RETINA SPECIALIST FOR RETINA SURGERY AND INTRAOCULAR LENS IMPLANTATION. AN INTRAOCULAR LENS WAS IMPLANTED IN (B)(6) 2025.

  Patient problems: Capsular Bag Tear

  MAUDE report 23705078 ↗
• InjuryMay 29, 2025Unintended Ejection; Unintended Ejection

  REPORTEDLY, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IN THE LEFT EYE THE INJECTOR PLUNGER SHOT FORWARD WHEN IN THE EYE AND THERE WAS A POSTERIOR CAPSULE (PC) TEAR. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL WITH THE SAME MODEL AND POWER. THE PATIENT WAS PROVIDED WITH THE GLAUCOMA PROTOCOL. ADDITIONAL TREATMENT WAS NOT REQUIRED. ADDITIONAL INFORMATION IS NOT AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 22102981 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, A BENT HAPTIC WAS NOTICED. THE INCISION WAS ENLARGED FOR THE REMOVAL OF THE IOL, A BACK UP LENS WAS IMPLANTED, AND THE WOUND WAS CLOSED WITH NYLON SUTURES. OUTCOME OF THE PATIENT IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752085 ↗
• InjuryFeb 5, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED APPROXIMATELY THREE MONTHS AFTER IMPLANT OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE PATIENT PRESENTED WITH BLURRY VISION. THE SURGEON REPORTED AN IOL FRAGMENT WAS OBSERVED ON THE ANTERIOR SURFACE. A SUCCESSFUL LENS EXCHANGE WAS COMPLETED. IN THE SURGEON'S OPINION, THE CAUSE OF THE EVENT IS UNKNOWN, AND THE PATIENT'S OUTCOME IS GOOD.

  Patient problems: Blurred Vision

  MAUDE report 21312423 ↗
• MalfunctionNov 19, 2024Crack; Crack

  IT WAS REPORTED THAT DURING INSERTION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE LENS CAME THROUGH THE SIDE OF THE INJECTOR, ALLEGEDLY CAUSED BY A CRACK IN THE INJECTOR. THE INITIAL IOL WAS REMOVED INTRAOPERATIVELY, AND A BACKUP LENS WAS SUCCESSFULLY IMPLANTED. PATIENT OUTCOME IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724479 ↗
• InjuryJul 20, 2024Failure to Eject; Failure to Eject

  REPORTEDLY, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL HAPTIC BECAME STUCK IN THE INJECTOR, AND IT WAS UNABLE TO EJECT. SURGEON WAS UNABLE TO PROCEED WITHOUT AN IOL, THEREFORE, PATIENT WAS LEFT APHAKIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. THIS REPORT REFLECTS INJECTOR 2 OF 3. REFERENCE REPORT NUMBERS: 0001313525-2024-00122 AND 0001313525-2024-00124.

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

  MAUDE report 19787569 ↗
• InjuryJul 20, 2024Failure to Eject; Failure to Eject

  REPORTEDLY, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL HAPTIC BECAME STUCK IN THE INJECTOR, AND IT WAS UNABLE TO EJECT. SURGEON WAS UNABLE TO PROCEED WITHOUT AN IOL, THEREFORE, PATIENT WAS LEFT APHAKIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. THIS REPORT REFLECTS INJECTOR 3 OF 3. REFERENCE REPORT NUMBERS: 0001313525-2024-00122 AND 0001313525-2024-00123.

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

  MAUDE report 19787568 ↗
• InjuryJul 20, 2024Failure to Eject; Failure to Eject

  REPORTEDLY, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL HAPTIC BECAME STUCK IN THE INJECTOR, AND IT WAS UNABLE TO EJECT. SURGEON WAS UNABLE TO PROCEED WITHOUT AN IOL, THEREFORE, PATIENT WAS LEFT APHAKIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. THIS REPORT REFLECTS INJECTOR 1 OF 3. REFERENCE REPORT NUMBERS: 0001313525-2024-00123 AND 0001313525-2024-00124.

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

  MAUDE report 19787567 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE EYE, IT WAS NOTICED THAT A HAPTIC WAS BENT. THE INCISION WAS ENLARGED, THE IOL WAS REMOVED, AND A BACKUP LENS WAS IMPLANTED WITH NO ADVERSE EVENT NOTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134531 ↗
• MalfunctionApr 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE INSERTION OF AN INTRAOCULAR LENS (IOL) THE DISTAL TIP OF THE INSERTER SPLIT, CAUSING THE LENS TO EXIT LATERALLY. A BACKUP LENS WAS SUCCESSFULLY IMPLANTED AND THERE WAS NO PATIENT INJURY. FOUR UNOPENED INSERTERS FROM SAME LOT WERE RETURNED AND, UPON EVALUATION, ONE OF THE FOUR EXHIBITED A CRACK IN THE TIP. THIS REPORT CORRESPONDS TO THE UNOPENED INSERTER WHICH WAS RETURNED AND IS REPORT 3 OF 3. REFERENCE: 0001313525-2024-70063 AND 0001313525-2024-70064

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050105 ↗
• MalfunctionMar 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS IS REPORT 2 OF 3. REFERENCE 0001313525-2024-00077 AND 0001313525-2024-70063.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851857 ↗
• MalfunctionMar 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS IS REPORT 1 OF 3. REFERENCE 0001313525-2024-70064 AND 0001313525-2024-00077.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851380 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, IOL WAS REMOVED AFTER INSERTION DUE TO DAMAGED HAPTIC. INCISION WAS ENLARGED TO REMOVE THE IOL, AND A SUTURE WAS REQUIRED TO CLOSE THE WOUND. PATIENT WAS LEFT APHAKIC. PER THE SURGEON THE LENS WAS NOT ABLE TO STICK TO THE EYE. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Visual Impairment

  MAUDE report 18741694 ↗
• InjuryNov 15, 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 EYE, THE SURGEON NOTICED THE FRONT HAPTIC WAS KINKED. THE INCISION WAS ENLARGED TO ALLOW FOR REMOVAL OF THE IOL AND THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL IOL. SUTURES WERE USED TO CLOSE THE WOUND. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF EVENT WAS A BAD LOAD, REPORTING THE TECH ADVANCED THE TAB TOO FAST. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145385 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE POSTERIOR CAPSULE RUPTURED CAUSING THE LENS TO BE UNSTABLE. THE INCISION WAS ENLARGED TO ALLOW FOR REMOVAL OF THE IOL AND A SUTURE WAS PLACED AS STANDARD PROTOCOL. APPROXIMATELY TEN DAYS AFTER EXPLANT, A VITRECTOMY WAS PERFORMED AND A LENS OF THE SAME MODEL, SAME DIOPTER WAS IMPLANTED. PATIENT OUTCOME IS GOOD.

  Patient problems: Capsular Bag Tear

  MAUDE report 17701922 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS REMOVED AND REPLACED INTRAOPERATIVELY DUE TO A BENT HAPTIC. THE INCISION WAS ENLARGED. NO SUTURES WERE REQUIRED AND THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724505 ↗
• MalfunctionMar 1, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER LOADING THE INTRAOCULAR LENS(IOL) INTO THE INJECTOR, THE IOL WAS PROTRUDING OUT THE SIDE OF THE INJECTOR. THE PROTRUSION WAS NOTICED DURING PREPARATION FOR USE, AND THERE WAS NO CONTACT OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16458995 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE EYE, IT WAS NOTICED THE HAPTIC WAS DAMAGED, ALLEGEDLY BY THE SLIDE MECHANISM OF THE INJECTOR. THE INCISION WAS ENLARGED AND A SUCCESSFUL INTRAOPERATIVE LENS REPLACEMENT USING THE SAME MODEL AND DIOPTER IOL WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16381035 ↗
• InjuryDec 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE IT WAS DISCOVERED THAT IOL HAPTICS WERE BENT. THE SURGEON ATTEMPTED TO STRAIGHTEN THE HAPTICS AND DURING THE PROCESS THE IOL FLIPPED OVER AND SCRATCHED THE CORNEA. ON POST-OP VISIT IT WAS DISCOVERED THAT LENS HAD SHIFTED CAUSING PAIN AND VISUAL PROBLEMS FOR THE PATIENT. THE LENS WAS EXPLANTED 3 DAYS POST IMPLANT DUE TO LENS DISLOCATION AND EXTRUDED LENS IN THE ANTERIOR CHAMBER. A VITRECTOMY WAS PERFORMED, AND THE LENS WAS REPLACED WITH ANOTHER IOL OF THE SAME MODEL AND DIOPTER.

  Patient problems: Corneal Scar; Eye Pain; Visual Impairment

  MAUDE report 16042805 ↗
• InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE INSERTING THE INTRAOCULAR LENS (IOL) THE END OF THE LEADING HAPTIC BROKE OFF. THE SURGEON WAS ABLE TO REMOVE THE PIECE OF HAPTIC, BUT THE SURGEON REPORTS IT CAUSED RIP IN THE POSTERIOR CAPSULAR BAG WITH LOSS OF VITREOUS, REQUIRING A VITRECTOMY. THE IOL WAS PLACED IN THE CILIARY SULCUS INSTEAD OF THE CAPSULAR BAG, WHICH WAS A CHANGE IN THE SURGERY PLAN. THE IOL DAMAGE WAS OBSERVED INTRAOPERATIVELY. THE SURGEON BELIEVES THE IOL IS DEFECTIVE. THE INCISION WAS NOT ENLARGED, AND NO SUTURES WERE REQUIRED. THE LENS REMAINS IMPLANTED. THE PATIENTS VISION APPEARS TO BE RECOVERING WELL. THERE IS STILL VITREOUS IN THE ANTERIOR CHAMBER, SO THE SURGEON IS CONCERNED ABOUT THE DEVELOPMENT OF CYSTOID MACULAR EDEMA. THE PATIENT WILL BE RETURNING FOR A FINAL POSTOPERATIVE EVALUATION.

  Patient problems: Blurred Vision; Capsular Bag Tear; Macular Edema; No Code Available; Vitrectomy

  MAUDE report 9615688 ↗