TECNIS IOL ZLB00 (REF ZLB00U0185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 05050474560642), received between Aug 22, 2016 and Jan 12, 2024 — classified as 24 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2024Material Split, Cut or Torn; Ejection Problem; Material Split, Cut or Torn; Ejection Problem

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS DID NOT COME DOWN FROM THE CARTRIDGE PROPERLY AND TORE THE LENS. ADDITIONAL INFORMATION INDICATED THAT THE LENS WAS NOT IN CONTACT WITH THE EYE ONLY THE CARTRIDGE TIP MAKE CONTACT WITH THE EYE. THE REASON FOR THE ISSUE WAS LOADING ERROR. THE PROCEDURE WAS COMPLETED WITH THE BACK UP LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18505194 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED AN EXPLANT OF THE INTRAOCULAR LENS (IOL) FROM THEIR LEFT EYE (OS). THE IOL WAS REPLACED WITH ANOTHER JOHNSON AND JOHNSON DEVICE, ZLB00, 20.0 DIOPTER. THE IOL WILL NOT BE RETURNED FOR INVESTIGATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Eye Injury

  MAUDE report 15849137 ↗
• InjuryNov 10, 2021Application Program Problem: Dose Calculation Error; Adverse Event Without Identified Device or Use Problem; Application Program Problem: Dose Calculation Error; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER EXPLANTED AN INTRAOCULAR LENS (IOL) DUE TO PATIENT COMPLAINING OF INSUFFICIENT NEAR VISION AND WAS ALSO EXPERIENCING DYSPHOTOPSIA. ACCOUNT PROVIDED THAT PATIENT HAS SLOW VISUAL ADAPTATION WITH MILD REFRACTIVE ERROR. THE REPLACEMENT IOL WAS OF A DIFFERENT MODEL AND DIOPTER SIZE. THERE WAS NO FURTHER SURGICAL INTERVENTION REQUIRED. PATIENT WAS REPORTEDLY DOING WELL AND HAS BEEN HAPPY WITH THEIR VISION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 12791732 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT INDICATING THAT THE INTRAOCULAR LENS (IOL), MODEL ZLB00, WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO EXPERIENCING HALOS, STARBURST AND POOR VISION. THE DOCTOR CLARIFIED THAT THE PATIENT HAD FRONTAL ARCUATE INCISIONS OVERCORRECTING HIS ASTIGMATISM. THE REPLACEMENT LENS WAS ANOTHER JOHNSON AND JOHNSON LENS OF DIFFERENT MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY REPORTED AND NO FURTHER INTERVENTION WAS REQUIRED. REPORTEDLY THE PATIENT OUTCOME IS EXCELLENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Flashers; Halo

  MAUDE report 12558607 ↗
• InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2020. THE IOL WAS EXPLANTED ON (B)(6) 2020 DUE TO COMPLAINT THAT THE DOCTOR WAS ABOUT A DIOPTER AND A HALF OFF ON THE LENS AND REPLACED WITH THE SAME MODEL LENS WITH A DIFFERENT DIOPTER SIZE. THERE WAS NO COMPLICATIONS, SUCH AS CAPSULAR TEAR, NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), AND NO UNPLANNED VITRECTOMY. IT WAS ALSO REPORTED THE PATIENT HAD HYPERTENSION AND OCULAR HYPERTENSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10227485 ↗
• InjuryJun 2, 2020Adverse 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 FROM PATIENT'S LEFT EYE AS THE PATIENT WAS UNHAPPY. THE VISION WAS BLURRY AT 1 DAY POST-OP AND WAS EXPERIENCING SUB-OPTIMAL VISION AT DISTANCE AND MID-NEAR. PATIENT'S ACTIVITIES WERE TREMENDOUSLY AFFECTED AND WAS EXPERIENCING DIFFICULTY WITH WATCHING TV, READING UP CLOSE AND WORKING ON COMPUTER. PATIENT WAS USING MULTIPLE READING GLASSES TO HELP FOR ALL FOCAL LENGTHS DUE TO HYPEROPIC OUTCOME. NO OTHER SURGERY OR MEDICAL INTERVENTION WAS REQUIRED AND NO SUTURE WAS PLACED. NO OTHER RX WAS GIVEN OTHER THAN NORMAL POST-OP DROPS. THE REPLACEMENT LENS USED IS A SAME MODEL BUT DIFFERENT DIOPTER LENS. PATIENT WAS DOING VERY WELL AT THE TIME OF DISCHARGE. PATIENT/ USER OUTCOME: PRE-OP VISUAL ACUITY W/ GLASSES 20/25, VISUAL ACUITY WITH TMF ( IMPLANTED ON (B)(6) 2019) 20/50, READING J7 @22'''', VISUAL ACUITY WITH TMF IOL EXCHANGE ON (B)(6) 2020, 20/20, READING J1 @16''''. NO OTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10112173 ↗
• InjuryDec 28, 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 IMPLANTED IN THE PATIENT¿S RIGHT EYE. THE PATIENT STATED THAT THE VISION WAS CLEARER RIGHT AFTER SURGERY BUT HALOS, STARBURSTS, POSITIVE DYSPHOTOPSIA, AND INABILITY TO DRIVE AT NIGHT OCCURRED RIGHT AFTER SURGERY. THE IOL WAS EXPLANTED/EXCHANGED, AND PARS PLANA VITRECTOMY WAS PERFORMED. THE REPLACEMENT LENS IS A NON-JOHNSON & JOHNSON LENS. THERE WAS NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances; Vitrectomy

  MAUDE report 9528279 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE. THE PATIENT WAS INTOLERANT OF THE LENS; THEREFORE, THE LENS WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, PATIENT IS DOING FINE POST EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9380163 ↗
• InjuryOct 28, 2019Adverse 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 DUE TO MECHANICAL FAILURE. THROUGH FOLLOW UP, IT WAS REPORTED THE PATIENT HAD SYMPTOMS OF BLURRED VISION AT NEAR AND INTERMEDIATE RANGE OF VISION. SPECTACLE CORRECTION DID NOT RESOLVE THE BLUR. THE LENS WAS REPLACED WITH A NON-JOHNSON & JOHNSON REPLACEMENT LENS. THE INCISION WAS ENLARGED, HOWEVER, THERE WERE NO OTHER COMPLICATIONS. THE PATIENT IS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9244253 ↗
• InjurySep 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE. THE LENS WAS DISPLACED DUE TO TEAR IN CAPSULE, THAT TOOK PLACE AT THE TIME OF IMPLANT CAUSING THE LENS TO SHIFT. THE DISLOCATION WAS OBSERVED IN THE POST OPERATIVE EXAMINATION. REPORTEDLY, ANOTHER LENS A MODEL ZA9003, WAS USED AS REPLACEMENT FOR THE PATIENT AND WAS PLACED IN THE SULCUS. THERE WAS NO INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY REQUIRED. THE PATIENT WAS DOING FINE. NO OTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 9101421 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) GOT STUCK IN THE WOUND. AN INCISION ENLARGEMENT WAS REQUIRED AND A REPLACEMENT LENS WAS USED. FURTHER, IT DID NOT CONTRIBUTE TO A PATIENT INJURY. THERE WAS NO PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8975764 ↗
• InjuryJun 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A RESIDUAL REFRACTIVE ERROR WITH THE IMPLANTED INTRAOCULAR LENS (IOL). THE PATIENT COMPLAINED OF GLARE AND BLURRED VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS OF THE SAME MODEL BUT HIGHER DIOPTER. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED. THERE WERE NO POST-OPERATIVE COMPLICATIONS.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8694288 ↗
• InjuryMay 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MULTIFOCAL INTRAOCULAR LENS (MODEL ZLB00 +18.0 DIOPTER) WAS EXPLANTED FROM THE RIGHT EYE (OD) DUE TO THE PATIENT EXPERIENCING HALOS AND GLARE. A MONOFOCAL LENS (MODEL ZCB00 +18.5 DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED BUT SUTURES WERE USED. REPORTEDLY, THE PATIENT IS DOING WELL POST LENS EXCHANGE. THE ACCOUNT COMMENTED THAT THE EXPLANTED LENS IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8580834 ↗
• InjuryMar 13, 2019Adverse 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 FROM THE RIGHT EYE DUE TO PATIENT EXPERIENCING DYSPHOTOPSIA. PATIENT OUTCOME NOTED THE PATIENT DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8415272 ↗
• InjuryMar 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN HYPEROPIC SURPRISE CAUSING THE FEMALE PATIENT TO HAVE FUZZY AND POOR VISION, AFTER THE IMPLANTATION OF THE ZLB00 +18.5 DIOPTER IOL (INTRAOCULAR LENS) IN HER RIGHT EYE (OD). AS A RESULT, THE LENS WAS EXPLANTED AND REPLACED WITH A ZLB00 +19.0 DIOPTER. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. PATIENT'S VISUAL ACUITY PREOPERATIVE: 20/25+2. PATIENT'S VISUAL ACUITY POSTOPERATIVE: 20/40. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 8411194 ↗
• InjuryFeb 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS PLANNED FOR EXPLANT AS THE PATIENT WAS DISSATISFIED WITH THE LENS. FURTHER INFORMATION WAS PROVIDED AND CONFIRMED LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AS PLANNED. THE SAME MODEL, A LARGER 19.5 DIOPTER WAS THE REPLACEMENT LENS. INCISION WAS NOT ENLARGED. EXPLANT WAS PERFORMED WITHOUT INCIDENT. THE PATIENT IS DOING WELL.

  Patient problems: No Code Available

  MAUDE report 8330037 ↗
• InjuryNov 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2018 THAT THE DOCTOR IS ASKING FOR ASSISTANCE IN INTRAOCULAR LENS (IOL) POWER CALCULATION FOR A PATIENT FOR SURGERY ON (B)(6) 2018. PATIENT IS GOING TO HAVE AN IOL EXCHANGE, RIGHT EYE (OD) PROCEDURE DUE TO REFRACTIVE SURPRISE. INFORMATION PROVIDED IN FOLLOW-UP; PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) 20/10, POST-OP 20/50. THE REPLACEMENT LENS MODEL IS ZMB00, 19.5 DIOPTER IOL, THE EXPLANT SURGERY WENT WELL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8092247 ↗
• InjuryAug 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 18.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT''S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO HALOS AND GLARE. PRE-OPERATIVELY, THE PATIENT''S VISUAL ACUITY WAS 20/40. THE PATIENT''S POST-OPERATIVE VISUAL ACUITY WAS 20/30 AND THE GLARE AND HALOS HAD IMPROVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7791936 ↗
• InjuryAug 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 18.5 DIOPTER LENS WAS INSERTED INTO THE PATIENT'S OPERATIVE EYE, BUT WAS REMOVED AND REPLACED. AN ANTERIOR VITRECTOMY WAS PERFORMED. A MODEL ZMA00 17.5 DIOPTER LENS WAS IMPLANTED AS THE REPLACEMENT. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 7740525 ↗
• InjuryJun 5, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON DAY ONE POST-OP DUE TO ANTERIOR CAPSULE - POSTERIOR CAPSULE RUPTURE, THE INTRAOCULAR LENS (IOL) DIDN'T STAY CENTERED AS THE CAPSULAR BAG WASN¿T STABLE AS THE SURGEON EXPECTED. REPORTEDLY, THE RETINAL DOCTOR DID A VITRECTOMY AND EXPLANTED THE INTRAOCULAR LENS (MODEL ZLB00, +18.5 DIOPTER) IN A SECONDARY SURGICAL PROCEDURE FROM THE PATIENT¿S OPERATIVE EYE. A COMPETITOR MONOFOCAL THREE-PIECE IOL WAS USED AS A REPLACEMENT LENS. THE PATIENT WAS REPORTED DOING EXCELLENTLY WHEN DISCHARGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 7568919 ↗
• InjuryApr 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 18.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT EXPERIENCED BLURRY VISION. THESE SYMPTOMS SIGNIFICANTLY INTERFERE WITH HER REGULAR ACTIVITIES. SHE CAN DRIVE BUT HAS TO BE VERY CAREFUL. SHE ALSO CANNOT READ FINE PRINT, SIGNS ARE TOO BLURRY. FURTHERMORE, THE DOCTOR ADVISED THE PATIENT TO GIVE IT SOME TIME FOR HER TO ADJUST TO THE LENS. THE PATIENT HAS BEEN BACK TO SEE THE DOCTOR AND NOW HAS TO WEAR BIFOCALS. THE PATIENT WAS ALSO REFERRED TO A RETINA SPECIALIST WHO STATED SHE HAD THE BEGINNING OF MACULAR DEGENERATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 7453285 ↗
• InjuryFeb 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (IOL) MODEL ZLB00, 18.5 DIOPTER WAS EXPLANTED IN A SECONDARY PROCEDURE FROM THE PATIENT''S RIGHT EYE WHICH WAS INITIALLY IMPLANTED AT DIFFERENT FACILITY. A MODEL ZXT225, 18.5 DIOPTER IOL WAS IMPLANTED AS THE REPLACEMENT LENS FOR THE PATIENT. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS DOING FINE POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7296997 ↗
• InjuryFeb 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. HOWEVER, AN EXPLANT IS PLANNED TO BE PERFORMED DUE TO THE PATIENT NOT ADAPTING WELL TO THE IOL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7262694 ↗
• MalfunctionFeb 24, 2017Break; Sticking; Failure to Unfold or Unwrap; Break; Sticking; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT DURING IMPLANTATION, WHEN THE INTRAOCULAR LENS (IOL) WAS COMING OUT OF THE CARTRIDGE, ONE HAPTIC WAS STUCK TO THE LENS. REPORTEDLY, WHILE ATTEMPTING TO FREE THE HAPTIC, THE LENS WAS DAMAGED AND HAD TO BE REMOVED FROM THE EYE. ANOTHER LENS, SAME MODEL BUT WITH HIGHER DIOPTRE (+19.0) WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6356572 ↗
• InjuryFeb 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DUE TO BLURRY VISION AND IOL COMPLICATIONS, IT WAS REPORTED THAT A MODEL ZLB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT'S LEFT EYE AND WAS REPLACED WITH A MODEL ZXR00, 19.5 DIOPTER IOL. THROUGH FOLLOW-UP IT (B)(4) CONFIRMED THAT THE PATIENT IS CURRENTLY OKAY AND HAS NOT HAD ANY OTHER CONCERNS OR ISSUES. IT WAS ALSO LEARNED THAT THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6355066 ↗