TECNIS IOL ZCB00 (REF ZCB0000120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474531550), received between Jan 24, 2017 and Aug 22, 2025 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT A REFRACTIVE SURPRISE OCCURRED FOLLOWING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) MODEL ZCB00. THE TARGET REFRACTION WAS PLANO, BUT POST-SURGERY REFRACTION WAS RECORDED AS -3.00-0.25×001. THE PATIENT EXPERIENCED BLURRY DISTANCE VISION (DISTANCE VISUAL ACUITY) POST-OPERATIVELY, WHICH IMPACTED DAILY ACTIVITIES. THE PRE-OPERATIVE VISUAL ACUITY WAS 20/50 WITH A REFRACTION OF -10.00-0.25×140 AND POST-OPERATIVE VISUAL ACUITY WAS 20/20 WITH A REFRACTION OF -3.00-0.25×001. THE PATIENT FULLY RECOVERED. THE REPLACEMENT LENS MODEL IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22874881 ↗
• MalfunctionApr 2, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT A SURGEON FOUND A SCRATCH MARK ON A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) DURING A PROCEDURE ON (B)(6) 2025. THE ISSUE WAS IDENTIFIED AFTER THE LENS WAS IMPLANTED, AND THERE IS UNCERTAINTY REGARDING WHETHER THE SCRATCH WAS CAUSED BY THE INJECTOR OR IF THE LENS ITSELF WAS FAULTY. THE LENS WAS FULLY INSERTED. THE CUSTOMER INDICATED THAT THE LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE AND REPLACED WITH ANOTHER MONOFOCAL IOL, AND THE PATIENT WAS FULLY RECOVERED POST-OPERATION. DAILY ACTIVITIES WERE NOT AFFECTED. PRE-OPERATIVE VISION WAS 6/24. THERE WERE NO INCIDENCES OF INCISION ENLARGEMENT, NO SUTURES, AND NO VITRECTOMY REPORTED. THERE WAS NO DELAY IN THE PROCEDURE. UPON FOLLOW-UP, IT WAS STATED THAT MEDICATION WAS PRESCRIBED AS PART OF THE STANDARD THERAPEUTIC REGIMEN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752243 ↗
• MalfunctionNov 2, 2022Break; Break

  IT WAS REPORTED THAT AFTER INSERTING THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE, IT WAS FOUND THAT THE IOL WAS DAMAGED. THE IOL WAS REMOVED AND REPLACED WITH ANOTHER LENS. ACCOUNT INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15716865 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCBOO INTRAOCULAR LENS (IOL) HAPTIC CAUGHT ON THE PATIENT'S CAPSULAR BAG AND TORE IT. THE SURGEON HAD TO ENLARGE THE INCISION TO REMOVE THE LENS. VITRECTOMY ALONG WITH SUTURES WERE PLACED. A REPLACEMENT LENS IS A NON-JOHNSON AND JOHNSON LENS. THE CUSTOMER ALSO INDICATED THAT THE LENS WAS WASTED (DISCARDED). REPORTEDLY, PATIENT IS DOING OK POST SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Known Impact Or Consequence To Patient; Vitrectomy

  MAUDE report 9138633 ↗
• InjuryJun 13, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S OPERATIVE EYE, BUT THE HAPTIC WAS FOLDED OVER THE LENS. AN INCISION ENLARGEMENT WAS REQUIRED, HOWEVER, THERE WAS NO OTHER INTERVENTION, AND THERE WAS NO PATIENT INJURY. ANOTHER LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8697536 ↗
• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL ZCB00 +12.0 DIOPTER) WAS SCHEDULED TO BE EXPLANTED FROM PATIENT¿S LEFT EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT EXPERIENCING HYPEROPIC SURPRISE IMPACTING THE PATIENT WITH DECREASED VISUAL ACUITY. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT EXPLANT TOOK PLACE AS SCHEDULED. SUTURE WAS PLACED TO CLOSE THE WOUND. THERE WAS NO INCISION ENLARGEMENT, AND NO VITRECTOMY REQUIRED. REPORTEDLY LENS WITH SAME MODEL AND HIGHER DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. PATIENT WAS IN GOOD CONDITION AT DISCHARGE. VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): 20/40. VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT): BEST CORRECTED VISUAL ACUITY (BCVA 20/25+. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8572002 ↗
• MalfunctionMar 20, 2019Break; Break

  IT WAS REPORTED ZCB00 12.0 DIOPTER INTRAOCULAR LENS (IOL) WAS DAMAGED UPON INSERTION. THE PHYSICIAN BELIEVES THE PLATINUM 1 INSERTER CAUSED THE LENS DAMAGE AND NOT THE LENS THAT CAME DAMAGED. THE INSERTER THAT CAUSED THE DAMAGE HAS BEEN REMOVED FROM CIRCULATION FOR RETURN. THROUGH FOLLOW UP, THE PHYSICIAN PROVIDED ADDITIONAL INFORMATION CONFIRMING THE IOL WAS FULLY INSERTED INTO THE EYE WHEN THE LENS DEFECT WAS NOTICED, THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), NO VITRECTOMY, THE HAND-PIECE IS NOT DEFECTIVE AND STILL IN SERVICE. PATIENT OUT-COME POST PROCEDURE WAS REPORTED AS ROUTINE/NORMAL POST-OP COURSE. PHYSICIAN CLARIFIED THE DAMAGE TO THE IOL INVOLVED THE EDGE OF THE IOL AND WAS NOT OPTICALLY OR VISUALLY SIGNIFICANT, AND NO COMPLICATION OR INTERVENTION WAS ANTICIPATED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8438818 ↗
• InjuryJan 23, 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, +12.0 DIOPTER) WAS REMOVED FROM THE EYE AFTER INSERTION DUE TO A CAPSULAR TEAR. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE REPLACEMENT LENS WAS A THREE PIECE INTRAOCULAR LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 7213521 ↗
• MalfunctionSep 17, 2017Torn Material; Torn Material

  IT WAS REPORTED THAT THE DOCTOR NOTICED AFTER IMPLANTATION THAT A ZCB00 12.0 DIOPTER INTRAOCULAR LENS (IOL) WAS DAMAGED BY THE INSERTER. THE LENS WAS REMOVED AND REPLACED. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6871411 ↗
• InjuryJan 24, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  IT WAS REPORTED THAT ONE HAPTIC OF AN INTRAOCULAR LENS (IOL) WAS SHEARED OFF DURING INSERTION INTO THE EYE. THE LENS WAS INJECTED INTO THE CAPSULE AND IT WAS CUT IN HALF TO BE REMOVED. THE INCISION WAS ENLARGED AND A 10-0 NYLON SUTURE WAS USED TO CLOSE THE WOUND. THE DAMAGED LENS WAS REPLACED WITH ANOTHER LENS, SAME MODEL AND DIOPTER. ADDITIONAL INFORMATION REVEALED THAT THERE WAS NO ADDITIONAL PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6275193 ↗