TECNIS IOL ZCB00 (REF ZCB0000250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 05050474531819), received between Aug 31, 2016 and Jun 30, 2026 — classified as 24 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Break

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL ZCB00, INTO THE PATIENT¿S RIGHT EYE, THE POSTERIOR PORTION OF THE INJECTOR BECAME CLAMPED, RESULTING IN BREAKAGE OF THE LENS HAPTIC. THE ISSUE WAS IDENTIFIED IMMEDIATELY, AND THE SURGEON REPLACED THE IOL WITH A NEW LENS DURING THE SAME PROCEDURE. THE SURGERY WAS THEN COMPLETED SUCCESSFULLY WITHOUT FURTHER COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673331 ↗
• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT THREE PIECE MONOFOCAL NON-PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FOLLOWING POST-OPERATIVE ASSESSMENT DUE TO BROKEN HAPTICS. THE AFFECTED PATIENTS EXPERIENCED TEMPORARY IMPAIRMENT; HOWEVER, THEIR DAILY ACTIVITIES WERE NOT SIGNIFICANTLY IMPACTED. THERE WAS NO NEED FOR INCISION ENLARGEMENT, SUTURES, VITRECTOMY, OR DELAY IN THE PROCEDURE, AND NO ADDITIONAL MEDICAL ATTENTION OR MEDICATION WAS REQUIRED. AS PER ADDITIONAL INFORMATION RECEIVED, LENS WAS FULLY INSERTED INTO PATIENT'S EYE AND LENS WAS REMOVED IN SAME PROCEDURE AND REPLACED WITH LENS OF SAME MODEL. THERE WAS NO ANY PATIENT INJURY. PATIENT IS DOING GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361431 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  DURING INSERTION OF THE ZCB00 MODEL INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, THE CAPSULE BROKE AND UNPLANNED SUTURES WERE REQUIRED. PATIENT CONTACT WAS CONFIRMED. PATIENT PROGNOSIS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 24063462 ↗
• MalfunctionDec 24, 2025Use of Device Problem; Scratched Material; Use of Device Problem; Scratched Material

  A LOADING ISSUE AND SCRATCH ON THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WERE REPORTED AFTER BEING INSERTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). THE LENS WAS REMOVED DURING THE SAME PROCEDURE AND REPLACED WITH A BACK-UP ZCB00 25.0 IOL. THERE WAS NO VITRECTOMY HOWEVER, INCISION ENLARGEMENT, PROCEDURAL DELAYS, AND SUTURES ARE UNKNOWN. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS FULLY RECOVERED. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889639 ↗
• InjuryJun 25, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS PLACED IN THE PATIENT'S LEFT EYE, BUT WAS SUBSEQUENTLY REMOVED DUE TO PATIENT'S ANATOMY, AS THE CAPSULAR BAG COULD NOT MAINTAIN THE LENS IN THE CENTER. THE LENS WAS REMOVED AND REPLACED WITH A AR40E LENS IN THE SAME PROCEDURE. THE ISSUE WAS IDENTIFIED DURING THE IMPLANTATION PROCESS, AND THE PATIENT EXPERIENCED TEMPORARY IMPAIRMENT FOLLOWING THE SURGERY. THERE WAS INCISION ENLARGEMENT. THERE WAS DELAY IN PROCEDURE BY 45 MINUTES. THERE WAS MEDICATION PRESCRIBED. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE CAPSULAR BAG IS ABNORMAL. THERE WAS NO USE ERROR. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 22333198 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF REFRACTIVE SURPRISE AND THE EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION 24.0 DIOPTER LENS. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY DURING THE EXPLANT PROCEDURE. IOL DIRECTION FOR USE WERE FOLLOWED. DAILY ACTIVITIES THAT THE PATIENT CANNOT PERFORM THAT HE/SHE WAS ABLE TO PRIOR TO SURGERY, DELAY IN PROCEDURE, AND MEDICAL ATTENTION OR MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE) ARE UNKNOWN. PATIENT OUTCOME POST- LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 18956787 ↗
• MalfunctionOct 31, 2023Scratched Material; Scratched Material

  AFTER THE ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE), THERE WAS REPORTEDLY A SMALL IRREGULARITY OUTSIDE OF THE OPTIC THAT COULD NOT BE POLISHED OFF. THE IOL REMAINS IMPLANTED AS THE SMALL IRREGULARITY WAS VISUALLY INSIGNIFICANT AND THE PATIENT HAS NOT REPORTED ANY VISUAL ISSUES RELATED TO THE SMALL IRREGULARITY. IT IS UNKNOWN IF THERE WAS A PROCEDURAL DELAY HOWEVER, THERE WAS NO INCISION ENLARGEMENT, MEDICAL ATTENTION, MEDICATION PRESCRIBED, SUTURE(S), OR VITRECTOMY. THERE ARE NO PLANS FOR MEDICAL/SURGICAL INTERVENTION TO ADDRESS THE SMALL IRREGULARITY. POST-OPERATIVE VISION WAS REPORTED AS: 1D - UC 20/30 / 1W - BC 20/20, PRE-OPERATIVE VISION INFORMATION, HOWEVER, IS UNKNOWN. PATIENT'S DAILY ACTIVITIES ARE NOT SIGNIFICANTLY AFFECTED AND SHE HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18044533 ↗
• MalfunctionApr 28, 2023Break; Break

  IT WAS REPORTED, THE ZCB00 INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO THE PATIENT'S OPERATIVE EYE, WHEN BENT/BROKEN HAPTIC WAS NOTED. IT WAS ALSO REPORTED, THE LENS HAD PATIENT CONTACT. THERE IS NO INDICATION OF MEDICAL INTERVENTION OR SURGICAL INTERVENTION. THE PROCEDURE WAS COMPLETED USING A DIFFERENT MODEL LENS WITH THE SAME DIOPTER SIZE, DCB00 25.0 DIOPTER IOL. PATIENT STATUS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16836899 ↗
• MalfunctionFeb 21, 2023Break; Break

  IT WAS REPORTED TO REPLACE THE INTRAOCULAR LENS (IOL) AND NOT TO BILL. IT IS INDICATED THAT THERE IS A DEFECT/ISSUE. IT IS UNKNOWN IF THERE IS PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414905 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING ANISOMETROPIA DIPLOPIA. ANOTHER IOL WAS IMPLANTED; HOWEVER, THE CUSTOMER WAS UNABLE TO PROVIDE THE MODEL OR SERIAL NUMBER OF THE REPLACEMENT LENS. THERE WAS NO INCISION ENLARGEMENT REQUIRED, NO VITRECTOMY, AND NO SUTURES. THE CUSTOMER WAS UNABLE TO PROVIDE AN UPDATE ON THE PATIENT OUTCOME. THEY PLAN ON RETURNING THE EXPLANTED PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 14881062 ↗
• InjuryApr 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S OPERATIVE EYE. HOWEVER, THE LENS WAS REMOVED AND REPLACED WITH A 3-PIECE LENS IN A DIFFERENT PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 14119523 ↗
• MalfunctionApr 30, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT SURGEON FOUND A BLACK LINE ON THE INTRAOCULAR LENS (IOL) AFTER BEING IMPLANTED IN THE PATIENT'S EYE. SURGEON CONFIRMED THAT THERE WAS NO PROBLEM WITH PATIENT¿S VISUAL OUTCOME, AND NO INFLAMMATION OCCURRED DURING THE POST-EXAMINATION. NO SURGICAL INTERVENTION PERFORMED. THIS LENS WILL NOT BE EXTRACTED AND THE PATIENT OUTCOME IS FINE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11751287 ↗
• InjuryDec 4, 2020Break; Failure to Unfold or Unwrap; Break; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT AFTER LOADING AND INJECTING THE INTRAOCULAR LENS (IOL) IN THE ANTERIOR CHAMBER (AC), THE LEADING HAPTIC FAILED TO UNFOLD AND IT WAS FOUND TO BE CRACKED NEAR THE HAPTIC/ OPTIC JUNCTION. THE LENS HAD TO BE CUT IN THE AC AND WAS REMOVED. A NON-JOHNSON & JOHNSON 3 PIECE IOL WAS USED AS THE REPLACEMENT LENS. THERE WAS AN INCISION ENLARGEMENT; HOWEVER, NO OTHER SURGICAL INTERVENTIONS WERE REQUIRED. THERE WAS A TEN (10) MINUTES DELAY IN PROCEDURE. IT WAS NOTED THAT THE DEVICE WAS DISCARDED BY THE CUSTOMER AND IS NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10945997 ↗
• InjuryAug 13, 2020Failure to Deliver; Failure to Deliver

  THE ACCOUNT REPORTED THAT THEY HAD DIFFICULTIES LOADING THE INTRAOCULAR LENS (IOL) AND TRIED THREE (3) TIMES TO LOAD THE LENS. IT WAS INDICATED THAT THE DOCTOR ALWAYS MAKES SMALL INCISION. HE ATTEMPTED TO INSERT THE LENS AND ENLARGED THE INCISION. A NEW REPLACEMENT LENS WAS INSERTED WITHOUT DIFFICULTY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10405711 ↗
• InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS EXPERIENCING ISSUES WITH INTRAOCULAR LENS THAT WAS IMPLANTED IN PATIENT¿S BOTH OPERATIVE EYES. PATIENT IS EXPERIENCING REDNESS, SWELLING, A BURNING SENSATION, AND EXTREME MUCUS PRODUCTION. THE MUCUS BUILDUP IS LIKE A FILM OVER HER EYES AND IS NOTICED MOSTLY IN THE MORNING BUT DOES PERSIST THROUGHOUT THE DAY. THE REDNESS AND BURNING SENSATION HAVE SPREAD TO HER FACE. PATIENT STATED THAT THE ISSUES ARE APPROXIMATELY 10% WORSE IN THE RIGHT EYE. PATIENT HAS REPORTEDLY USED ANTIBIOTIC EYE DROPS FOR 6 WEEKS AND AFTER THAT USED ANTI-ALLERGY DROPS. THE SENSATION BEGAN 3 DAYS AFTER STOPPING THE ANTIBIOTICS. PER PATIENT, VISUALLY THE LENSES WORK, HOWEVER EXPERIENCING PAIN AND MUCUS. PATIENT USES COOL COMPRESS ON EYES TO REMOVE IT, OTHERWISE IT MAKES HER VISION BLURRY AND DIFFICULT DURING DRIVING. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT PATIENT¿S SYMPTOMS OF REDNESS AND BURNING STARTED 5 WEEKS AFTER CATARACT SURGERY WHEN THE STEROID AND ANTIBIOTIC DROPS STOPPED. PATIENT HAS SEEN THE OPHTHALMOLOGIST MULTIPLE TIMES AND THEY HAVE PRESCRIBED MULTIPLE ANTIBIOTICS AND STEROID EYE DROPS UNTIL THEY HAVE FOUND ONE THAT HELPS THE PATIENT. PATIENT IS

  Patient problems: Inflammation; Irritation; Pain

  MAUDE report 10149086 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE. REASON FOR EXPLANT IS UNKNOWN/NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9455958 ↗
• InjuryJul 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANT OF INTRAOCULAR LENS IN THE LEFT EYE. POST-IMPLANT, THE PATIENT UNDERWENT A LASIK PROCEDURE AND EXPERIENCED A REFRACTIVE SURPRISE. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER ZCB00 IOL, BUT A LOWER DIOPTER 22.5. AT EXPLANT THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE PATIENT IS REPORTED TO BE DOING FINE WITH NO OTHER COMPLICATIONS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8796433 ↗
• MalfunctionMay 24, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS DEBRIS ON THE INTRAOCULAR LENS (IOL). THERE WAS NO PATIENT CONTACT WITH THE IOL. THE EVENT WAS OBSERVED DURING HANDLING BUT PRIOR TO INSERTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8640834 ↗
• InjuryMay 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VISION OF THE PATIENT WAS NOT AS EXPECTED DURING THE POST-OP EXAMINATION. THERE WAS A REFRACTIVE SURPRISE. THROUGH FOLLOW-UP WE LEARNED THAT THE TARGET WAS ¿ 2.67 (BARRETT UNIVERSAL). AN EXPLANT WAS PERFORMED, AND THE EXPLANTED LENS WAS REPLACED WITH ANOTHER ZCB00 OF A LOWER DIOPTER (23.5). NO SUTURES, INCISION ENLARGEMENT OR VITRECTOMY WERE NECESSARY AND NO DELAY OCCURRED. THE PATIENT SHOWS IMPROVEMENT SHORTLY AFTER SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8629677 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CALLED TO REPORT HER EXPERIENCE WITH THE INTRAOCULAR LENS (IOL)IMPLANTED IN HER LEFT EYE. PATIENT REPORTS HAVING BILATERAL LENS IMPLANTS (B)(6) 2017. OVER THE PAST WEEKEND SHE STARTED HAVING SOME ISSUES WITH THE LENS IN HER LEFT EYE. SHE IS EXPERIENCING STREAKS OF LIGHT IN THE LEFT EYE, SHE CAN SEE THE EDGE OF THE LENS, HAS LIGHT FLASHES, AND BIG SPOTS OF BLACK FLOATERS WHEN SHE LOOKS LEFT AND RIGHT AND SEES THE LENS MOVING. IT IS ALSO CLOUDY. AFTER THE LENSES WERE IMPLANTED SHE WAS IN HER DOCTOR'S OFFICE EVERY OTHER WEEK. SHE HAD ENHANCEMENTS AS SHE WAS HAVING ALL KINDS OF ISSUES. SHE HAD THE ENHANCEMENTS IN (B)(6) 2018, AND THEN ANOTHER ENHANCEMENT OCTOBER 2018. SHE ALSO STATED SHE IS SCHEDULED FOR A YAG (B)(6) 2019. AS THE CONSUMER WAS IN NEVADA VACATIONING, SHE CONTACTED AND MADE AN APPOINTMENT WITH A LOCAL OPHTHALMOLOGIST. THE DOCTOR DID A FULL EXAM INCLUDING DILATING HER EYES AND LOTS OF TESTS. THE DOCTOR TOLD HER TO WATCH FOR ANY SIGNS, LIKE A VAIL, FLOATERS, OR AN EXPLOSION OF WHITE BRIGHT LIGHT. IT COULD BE A DETACHED RETINA. IF SHE HAS ANY SIGNIFICANT ISSUES SHE NEEDS TO CALL HIM AGAIN. SHE DOES HAVE A FOLLOW UP APPOINTMENT, (B)(6) 2018. RIGHT NOW IT IS STILL

  Patient problems: Blurred Vision; Visual Disturbances; Vitreous Floaters

  MAUDE report 8427487 ↗
• MalfunctionMar 8, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT OPTIC OF THE TECNIS MONOFOCAL INTRAOCULAR LENS WAS CRACKED BUT WAS IMPLANTED IN PATIENT¿S EYE. THIS EVENT WAS OBSERVED WHILE INSERTING LENS INTO THE EYE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURE REQUIRED. THE LENS REMAINS IMPLANTED. REPORTEDLY THERE WAS NO SURGICAL OR MEDICAL INTERVENTION PERFORMED OR PLANNED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8402561 ↗
• InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A ZCB00 25.0 DIOPTER INTRAOCULAR LENSES (IOL) WAS EXPLANTED FROM THE PATIENT¿S OCULAR SINISTER (LEFT EYE) DUE TO THE PATIENT¿S EYE ANATOMY BEING UNABLE TO SUPPORT THE ZCB00 LENS. IT WAS REPORTED A VITRECTOMY WAS PERFORMED AND THE PATIENT WAS LEFT APHAKIC FOR TWO (02) WEEKS TO HEAL. PATIENT RETURNED ON A LATER SURGERY DATE AND AN ANTERIOR CHAMBER (AC) IOL WAS INSERTED USING THE APPROPRIATE CARTRIDGE AND INJECTOR. THIS REPORT CAPTURES THE NONFOCAL EXPLANT EVENT. THE REPORTED MULTIFOCAL EXPLANT WILL BE CAPTURED IN A SEPARATE REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 8388239 ↗
• InjuryDec 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD MYOPIC OUTCOME AND DECREASED VISUAL ACUITY AFTER IMPLANTATION OF MODEL ZCB00 25.0 DIOPTER TECNIS MONOFOCAL IOL (INTRAOCULAR LENS). THE LENS WAS EXPLANTED AND REPLACED WITH MODEL ZCB00 22.0 DIOPTER LENS. PATIENT WAS DOING FINE WHEN DISCHARGED. THERE WERE NO SECONDARY INTERVENTIONS REQUIRED SUCH AS INCISION ENLARGEMENT, SUTURE AND VITRECTOMY DURING THE REPLACEMENT. PATIENT'S VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): 20/50-2. PATIENT'S VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT): 20/100. PATIENT'S VISUAL ACUITY POST-OP (POST-REPLACEMENT): 20/25-2. BESIVANCE, LOTEMAX GEL, PROLENSA WERE GIVEN BY THE DOCTOR WERE NOTED TO BE OUTSIDE OF THE NORMAL POST-OPERATIVE TREATMENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8197594 ↗
• MalfunctionJun 28, 2018Detachment Of Device Component; Torn Material; Detachment Of Device Component; Torn Material

  IT WAS REPORTED THAT A ZCB00 25.0 DIOPTER LENS WAS OPENED FOR A COMBO CASE (PHACOEMULSIFICATION WITH IOL AND PARS PLANA VITRECTOMY). AS THE SURGEON INJECTED THE LENS INTO THE PATIENT'S LEFT EYE (OS), ONE OF THE HAPTICS BROKE OFF AND THEN THE LENS BROKE IN HALF. THE SURGICAL FACULTY WAS ABLE TO SUCCESSFULLY REMOVE THE BROKEN LENS AND IMPLANTED A ZA9003 23.5 DIOPTER LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. ALSO, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7647946 ↗
• InjuryJun 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CAPSULAR BAG TORE WHEN A ZCB00 25.0 DIOPTER LENS WAS BEING INSERTED INTO THE PATIENT'S OPERATIVE EYE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 7589622 ↗