TECNIS IOL ZCB00 (REF ZCB0000270)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474531857), received between Sep 12, 2016 and Aug 29, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Crack” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT REPORTED HAVING A NON-PRELOADED MONOFOCAL TORIC INTRAOCULAR LENS (IOL) IN HER LEFT EYE, WITH ASTIGMATISM NOT YET CORRECTED IN THAT EYE. THE PATIENT ALSO HAS A NON-PRELOADED MONOFOCAL IOL IN HER RIGHT EYE. DURING A VISIT WITH A SECOND DOCTOR ON (B)(6) 2025, THE PATIENT WAS TOLD SHE HAS ASTIGMATISM IN HER LEFT EYE, AND THE DOCTOR RECOMMENDED CORRECTION TO IMPROVE HER VISION. THE PATIENT STATED THAT SHE HAS NOT EXPERIENCED ANY ISSUES WITH HER LEFT EYE (OS), THOUGH SHE STILL REQUIRES READERS. SHE PRIMARILY EXPERIENCES DRY EYE IN BOTH EYES, MANAGED WITH OVER-THE-COUNTER EYE DROPS. HER DISTANCE VISION IS FINE, AND HER CURRENT PRESCRIPTION FOR THE LEFT EYE IS SPHERE: -0.75, CYLINDER: +0.75, AXIS: 125 DEGREES. THE PATIENT REPORTED THAT HER INITIAL VISIT WAS FOR ISSUES IN HER RIGHT EYE, INCLUDING SEEING SPIDER WEBS AND SQUIGGLY LINES THAT MOVED IN ONE SIDE OF HER RIGHT EYE ¿SPECIFICALLY, ONE WEB AND A LINE THAT REMAINED STATIONARY IN DIFFERENT PARTS OF THE VISUAL FIELD. THE PATIENT UNDERWENT CATARACT SURGERY IN BOTH EYES IN 2023. A FEW MONTHS AFTER HER RIGHT EYE SURGERY, SHE EXPERIENCED NUMEROUS SPIDER WEBS, WHICH IMPAIRED HER VISION. IN FEBRUARY 2023, YTTRIUM-ALUMINUM-GARN

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 22926180 ↗
• InjuryApr 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE IMPLANT OF A TECNIS MONOFOCAL INTRAOCULAR LENS IN THE RIGHT EYE IN (B)(6) 2019 BY ANOTHER SURGEON. EMMETROPIA WAS TARGETED. IT WAS CONFIRMED BOTH THE TECNIS MONOFOCAL AND A RAYNER SULCOFLEX TRIFOCAL LENS WERE USED, AND BOTH LENSES REMAIN IMPLANTED TOGETHER IN THE RIGHT EYE. THE VISUAL ACUITY REACHED POST-OP WAS 0.63 (SUBJECTIVE REFRACTION) WITH -3.0 DIOPTER (DPT) CYLINDER (CYL) WITH SPHERE (SPH) ZERO (0) IN THE RIGHT EYE AND THE OBJECTIVE REFRACTION WITH THE LEFT EYE IS SPH + 2.5 DPT CYL -0.5 50°. THE PATIENT IS NOT SATISFIED WITH THE RESULT IN THE RIGHT EYE AND REQUESTS AN IMPLANT IN THE LEFT EYE. THE PATIENT IS AN ENGINEER IN MICROELECTRONICS, AND ALSO MICROSCOPE REFLECTIVE COMPONENTS, AND CAN DO THIS POORLY WITH THE RIGHT EYE, AS THESE REFLECT AND CAUSE HALOS. THIS DISTURBS HIM SIGNIFICANTLY AND HE NOW RELIES INCREASINGLY ON HIS LEFT EYE WHEN MICROSCOPING. THROUGH FOLLOW-UP WE LEARNED THAT THE PATIENT¿S SUBJECTIVE REFRACTION ON THE OPERATED RIGHT EYE IS AT -3.0 DIOPTER WITH A TARGET OF 0 DIOPTER. THE SURGEON PLANS TO IMPLANT AN EYEHANCE LENS IN THE LEFT EYE, BUT NO PROCEDURES HAVE BEEN PERFORMED IN EITHER EYE. NO ADDITIONAL INFORMAT

  Patient problems: Halo; No Code Available

  MAUDE report 9994482 ↗
• MalfunctionFeb 19, 2019Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT A ZCB00 27.0 INTRAOCULAR LENS WAS STUCK IN THE PACKAGE AND BENT INSIDE. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8349719 ↗
• InjuryNov 21, 2018Crack; Material Split, Cut or Torn; Crack; Material Split, Cut or Torn

  IT WAS REPORTED THAT MODEL A MODEL ZCB00 TECNIS MONOFOCAL IOL (INTRAOCULAR LENS) WAS OBSERVED CRACKED AND TORN ON EACH SIDE AFTER IMPLANTING IN PATIENT'S EYE. REPORTEDLY, THE CUSTOMER USED A NON-JOHNSON & JOHNSON INJECTION SYSTEM. LENS WAS IMPLANTED AND LEFT IN THE CAPSULAR BAG AND IS EXPECTED TO BE EXCHANGED, BUT NO DEFINITE DATE HAS BEEN SCHEDULED YET. THERE WAS NO PATIENT SYMPTOMS REPORTED. THE CUSTOMER HAS BEEN ADVISED TO USE JOHNSON AND JOHNSON INJECTIONS SYSTEMS WITH THE LENSES. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8096608 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL ZCB00, +27.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE BECAUSE OF PATIENT EXPERIENCING DECREASED VISION AND NEEDED A DIFFERENT DIOPTER. DURING THE PROCEDURE SUTURES WERE USED. CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INJURY. PATIENT WAS DOING GOOD AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7535937 ↗
• InjuryJan 30, 2018Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 27.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED DUE TO UNEXPECTED MYOPIC OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7229874 ↗
• InjuryAug 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A ZCB00 27.0 DIOPTER WAS IMPLANTED, THE DOCTOR NOTICED A VITREAL TEAR AND HAD TO PERFORM A VITRECTOMY. THE DOCTOR REPLACED IT WITH A DIFFERENT LENS DURING THE SAME SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 6829238 ↗
• InjurySep 12, 2016Adverse 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 IN A SECONDARY SURGERY FROM A FEMALE PATIENT'S RIGHT (OD) EYE. THE PATIENT HAD DIFFICULTIES WITH LENS (BLURRY VISION WHICH GOT WORSE) POST IMPLANT. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED AT EXPLANT AND NO PATIENT INJURY POST-OP WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 5944885 ↗