TECNIS IOL ZLB00 (REF ZLB00U0160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05050474560598), received between May 8, 2017 and Mar 17, 2021 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO A MECHANICAL FAILURE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. THROUGH FOLLOW-UP, IT WAS LEARNED THAT AFTER THE LENS IMPLANT, THE PATIENT COMPLAINED OF GHOSTING IN VISION AND VISION SEEMED CLOUDY. THE PATIENT DESCRIBED A LOSS OF DEPTH PERCEPTION THAT SEEMED WORSE WHEN DRIVING. DISTANCE VISION SEEMED CLOUDY, NEAR VISION WAS TERRIBLE, AND PATIENT COULD NOT SEE ANYTHING UP CLOSE. ANOTHER JOHNSON & JOHNSON LENS, MODEL AAB00, SAME DIOPTER WAS IMPLANTED AS A REPLACEMENT. SURGERY SUCCESSFUL WITH NO ISSUES WHEN PATIENT WAS DISCHARGED AFTER IOL EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 11500383 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT (OS) EYE IN A SECONDARY PROCEDURE DUE TO PATIENT BEING UNHAPPY WITH VISION POST-IMPLANT. THE REPLACEMENT LENS IS A NON-JOHNSON AND JOHNSON LENS WITH A HIGHER DIOPTER (16.5). THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED. REPORTEDLY, PATIENT IS DOING FINE POST-EXCHANGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Discomfort

  MAUDE report 11335999 ↗
• MalfunctionMar 19, 2020Contamination; Contamination

  AFTER ZLB00 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) THE SURGEON REPORTED THERE WAS AN ACRYLIC STRAND ORIGINATING ON THE POSTERIOR SURFACE OF THE IMPLANT IN THE PERIPHERY. BROADEST AT ORIGIN ENDING IN A WISP PROBABLY 3 MM TOTAL LENGTH AND FIRMLY ATTACHED. THE STRAND IS DEFINITELY NOT FROM CARTRIDGE, IT IS INTEGRAL TO THE LENS. SURGEON USED TWO INSTRUMENTS BUT COULD NOT SEPARATE THE STRAND FROM OPTIC AS IT WAS PART OF SAME ACRYLIC MATERIAL. THE CENTRAL OPTIC AND RINGS SEEMED NON COMPROMISED AND THE SURGEON ELECTED TO NOT EXCHANGE THE LENS. THROUGH FOLLOW UP, ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT IS VERY HAPPY. PATIENT WAS INFORMED OF THE DEFECT, THE DOCTOR¿S DECISION TO NOT EXPLANT THE LENS AND NON-VISUALLY SIGNIFICANT NATURE OF IT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9851816 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO MECHANICAL FAILURE. AT 1 WEEK POSTOP, PATIENT REPORTED SYMPTOMS OF CLOUDY, FUZZY, BLURRED VISION AT DISTANCE AND NEAR, AND GLARE WITH NIGHT DRIVING. A REFRACTION WAS PERFORMED AND THE SYMPTOMS COULD NOT BE RESOLVED WITH PRESCRIPTION LENSES. THE PATIENT WAS NOT ADAPTING TO THE MULTIFOCAL IMPLANT. PRE-OPS BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/40 AT DISTANCE AND J2 AT NEAR, BAT GLARE TESTING 20/400. POST-OPS BCVA IS 20/30 DISTANCE VISION AND J1 NEAR VISION. REPORTEDLY, THE PATIENT'S VISION IS GREAT NOW. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Impairment

  MAUDE report 9785078 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S EYE WITH INCISION ENLARGEMENT. EXPLANT WAS DUE TO THE PATIENT WHO EXPERIENCED REFRACTIVE SURPRISE, HYPEROPIC RESULT. NEVERTHELESS, THE PRE-OP VISUAL ACUITY WAS 20/30 AND POSTOP WAS 20/20. THE REPLACEMENT LENS IS ANOTHER ZLB00 HIGHER DIOPTER (17.5). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9556541 ↗
• InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THE ZLB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT COMPLAINT OF NOT BEING ABLE TO READ. ADDITIONAL INFORMATION RECEIVED REVEALED THE PATIENT COMPLAINED OF BLURRY VISION THE DAY AFTER THE IOL WAS IMPLANTED INTO THE RIGHT EYE. THE PATIENT DID NOT HAVE ANY CONTRIBUTING MEDICAL HISTORY. THE EXPLANTED IOL WAS EXCHANGED FOR A NON-JOHNSON AND JOHNSON IOL. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING WELL FOLLOWING THE EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 8706239 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE PATIENT BEING UNHAPPY WITH VISUAL OUTCOME DUE TO EXPERIENCING HAZY, BLURRY VISION, NIGHT HALOS, MULTIPLE VISION (NOT JUST DOUBLE). VISUAL ACUITY PRE-OP 20/40 AND THEN POST-OP 20/70. THE REPLACEMENT LENS WAS A CRYSTALLINE LENS. NO VITRECTOMY OR SUTURES WERE REQUIRED, BUT NOT SURE IF THERE WAS INCISION ENLARGEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 8639101 ↗
• InjuryMar 31, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A MECHANICAL COMPLICATION OF A ZLB00 MULTIFOCAL IOL (INTRAOCULAR LENS) POST IMPLANTATION AS THE PATIENT EXPERIENCED A HYPEROPIC SHIFT, GLARE, HALOS AND BLURRED VISION. THE OUTCOME WAS REPORTED TO SIGNIFICANTLY INTERFERE WITH THE PATIENT¿S DAILY ACTIVITIES. AS A RESULT, THE LENS WAS EXPLANTED AND REPLACED. THE PATIENT WAS REPORTED TO BE RECOVERING FROM THE IOL EXCHANGE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 8467976 ↗
• InjuryAug 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZLB00 +16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, BECAUSE THE PATIENT DIDN'T LIKE THE RESULTS; SHE WANTED TO BE ABLE TO SEE UP CLOSE CLEARLY. NO INCISION ENLARGEMENT TO REMOVE THE LENS, NO VITRECTOMY WAS PERFORMED AND NO PATIENT INJURY WAS REPORTED. A ZMB00 +17.0 DIOPTER LENS WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED DOING FINE POST-SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7741588 ↗
• InjuryMay 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNHAPPY WITH HIS/HER VISION AND HAS REQUESTED AN INTRAOCULAR LENS (IOL) EXCHANGE. THE PATIENT HAD COMPLETELY UNEVENTFUL SURGERY AND IS EXPERIENCING MONOCULAR DIPLOPIA. THE LENS EXCHANGE IS EXPECTED TO BE IN (B)(6). THERE WAS NO INJURY OR PRIOR SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7512865 ↗
• InjuryMay 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THE PHYSICIAN EXPLANTED A ZLB00 16.0 DIOPTER INTRAOCULAR LENS (IOL) DUE TO THE WRONG POWER BEING IMPLANTED INITIALLY. PER THE SURGERY CENTER A LENS LEFTOVER FROM THE PREVIOUS PROCEDURE WAS USED AND NO ONE CAUGHT IT. THROUGH FOLLOW UP IT WAS LEARNED THAT POST IMPLANT THE PATIENT WAS EXPERIENCING POOR VISION; POOR FOCUS. THE EXPLANTED LENS WAS EXCHANGED FOR ANOTHER ZLB00 WITH A HIGHER DIOPTER (21.5). THERE WAS NO PATIENT INJURY REPORTED AND POST EXCHANGE THE PATIENT IS REPORTED TO BE DOING WELL SO FAR. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7505243 ↗
• MalfunctionApr 26, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT A ZLB00 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS NOTICED SCRATCHED WHEN REMOVING FROM PACKAGING WITH NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7464399 ↗
• InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 16.0 MULTIFOCAL LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018, DUE TO THE PATIENT COMPLAINING OF NOT BEING ABLE TO SEE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND 3-4 SUTURES WERE USED TO CLOSE THE SIDE PORTS. REPORTEDLY, THERE WAS NO PATIENT INJURY. THE REPLACEMENT LENS WAS A ZCB00 16.5 MONOFOCAL LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7463307 ↗
• InjuryMay 8, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZLB00 16.0 DIOPTER WAS EXPLANTED DUE TO AN INCORRECT LENS POWER FOR THE PATIENT. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A HIGHER DIOPTER AND PATIENT IS NOW DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6553027 ↗