TECNIS IOL ZA9003 (REF ZA90030190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 05050474528994), received between Nov 1, 2016 and Aug 4, 2025 — classified as 27 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (21 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT'S EYE DURING SECONDARY SURGERY FOR AN UNSPECIFIED REASON. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 22709129 ↗
• MalfunctionMay 19, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED BY THE CUSTOMER THAT DURING THE IMPLANTATION OF A LENS, A HAPTIC BROKE OFF AND WAS ACCIDENTALLY THROWN AWAY. THE LENS WAS PARTIALLY INSERTED. THE SURGERY WAS COMPLETED IN THE SAME PROCEDURE WITH ANOTHER J&J LENS OF THE SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY AND PATIENT HAS FULLY RECOVERED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22048879 ↗
• MalfunctionMay 12, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT DURING A SCLERAL FIXATED INTRAOCULAR LENS (IOL) CASE ON (B)(6) 2025, THE HAPTIC ON THE LENS TORE, RESULTING IN THE LENS BEING EXPLANTED BY SURGEON. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006711 ↗
• MalfunctionOct 24, 2024Break; Break

  IT WAS REPORTED THAT THE STANDALONE 3 PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20529368 ↗
• MalfunctionSep 26, 2024Break; Break

  A BROKEN HAPTIC WAS NOTED BY THE DOCTOR FOLLOWING IMPLANTATION OF THE NON PRE-LOADED ZA9003 MODEL INTRAOCULAR LENS (IOL). A BACK-UP ZA9003 19.0 DIOPTER IOL WAS USED TO COMPLETE THE PROCEDURE AND WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED DURING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20314707 ↗
• InjuryAug 21, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS STUCK IN THE CARTRIDGE. BSS WAS USED AT THE ROOM TEMPERATURE AND DUOVISC WAS ALSO PULLED APPROXIMATELY 1 HOUR BEFORE APPLICATION. IT WAS LOADED AND DIRECTLY HANDED OFF TO THE SURGEON. THE LENS WAS MOVED CLOSER TO THE TIP AND WAS PARTIALLY INSERTED. THE ISSUE WAS OBSERVED DURING INSERTION. THERE WAS NO PATIENT INJURY. VITRECTOMY WAS REQUIRED AND WAS THOUGHT IT WAS DUE TO REMOVAL OF NATURAL LENS. IT WAS NOT KNOWN IF IT WAS THE JNJ DEVICE THAT REMOVED THE NATURAL LENS CAUSED CAPSULAR TEAR. PATIENT HAD FULL RECOVERED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 20021040 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE AND REPLACED WITH SOFTEC HDO +18.5 IN A SECONDARY PROCEDURE DUE TO NEGATIVE DYSPHOTOPSIA. THE ISSUE WAS FIRST IDENTIFIED DURING THE POST -OP EXAMINATION AND HAD PERSISTED FOR FIVE MONTHS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 18850728 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN 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 DYSPHOTOPSIA, WHICH PERSISTED FOR FOUR (04) MONTHS. THE EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION 18.5 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND THERE WAS NO VITRECTOMY. IT IS UNKNOWN IF MEDICAL ATTENTION WAS REQUIRED OR IF MEDICATION WAS PRESCRIBED OUTSIDE OF STANDARD CARE. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 17646241 ↗
• InjuryJul 26, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A BROKEN HAPTIC AND HAD TO BE CUT OUT OF THE RIGHT EYE. THE ISSUE WAS OBSERVED AFTER INSERTION. THE PATIENT HAD A COMPLICATION OF HYPHEMA. A VITRECTOMY WAS PERFORMED AND A TOTAL OF TWO SUTURES WERE PLACED. THE PATIENT HAD A HYPHEMA AND CORNEAL EDEMA AT ONE WEEK POST-OPERATIVE VISIT. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE SURGEON IS STILL AWAITING THE PATIENT'S ONE MONTH POSTOP APPOINTMENT TO FIND OUT IF THE CORNEAL EDEMA AND HYPHEMA ARE STILL PERSISTING. THE PATIENT STILL HAD SOME CORNEAL EDEMA ON DAY SIX AND WAS USING SOME ANTIBIOTIC AND STEROID DROPS FOR THAT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; Hyphema

  MAUDE report 17401347 ↗
• MalfunctionJul 26, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE LENS WAS SCRATCHED. THROUGH FOLLOW-UP IT WAS LEARNED THAT THERE WAS PATIENT CONTACT WITH THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397641 ↗
• MalfunctionJul 17, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INJECTED AND ONE OF THE HAPTICS WAS AMPUTATED. IT WAS NOTED THAT THE LENS WAS FULLY INSERTED. THE CUSTOMER HAD TO REMOVE THE LENS AND REPLACE IT WITH ANOTHER ONE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17339490 ↗
• InjuryJul 17, 2023Adverse 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 RIGHT EYE DUE TO DYSPHOTOPSIA. IT WAS INDICATED THAT THE PATIENT'S SYMPTOMS PERSISTED FOR 7 MONTHS. IT WAS REPLACED WITH A NON- JOHNSON AND JOHNSON IOL OF 18.5 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. THE PATIENT FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 17334425 ↗
• InjuryJun 20, 2023Adverse 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 OPERATIVE EYE DUE TO VISUAL DISTURBANCE. EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THE PATIENT FULLY RECOVERED POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 17167918 ↗
• InjuryOct 26, 2022Adverse 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 A PATIENT'S LEFT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO UNSPECIFIED VISUAL DISTURBANCES (DYSPHOTOPSIA). THE PATIENT HAS FULLY RECOVERED. NO MEDICATION OUT OF STANDARD CARE WAS PRESCRIBED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 15677900 ↗
• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DYSPHOTOPSIA IN THEIR LEFT EYE (OS) REQUIRING AN EXPLANT OF THE INTRA-OCULAR LENS (IOL). NO INCISION ENLARGEMENT OR SUTURES WERE NEEDED. PATIENT IS STATED TO BE FULLY RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 15374920 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DYSPHOTOPSIA IN THEIR RIGHT EYE (OD) REQUIRING AN EXPLANT OF THE INTRA-OCULAR LENS (IOL). SUTURES WERE REQUIRED DURING THE EXPLANT SURGERY. THE PATIENT IS STATED TO BE FULLY RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 15349691 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INCORRECT INTRAOCULAR LENS (IOL), MODEL ZCB00, 27.5 DIOPTER WAS FULLY INSERTED INTO THE LEFT EYE OF A PATIENT. THE LENS WAS REMOVED AND A DIFFERENT JOHNSON AND JOHNSON LENS, MODEL ZA9003, 19.0 DIOPTER WAS IMPLANTED DURING THE SAME PROCEDURE. AFTER THE REPLACEMENT LENS WAS INSERTED CAPSULE TEAR OCCURRED; THEREFORE, A VITRECTOMY WAS PERFORMED. NO OTHER INTERVENTIONS WERE MENTIONED. THE DAILY ACTIVITIES OF THE PATIENT WERE NOT SIGNIFICANTLY AFFECTED. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 15331832 ↗
• MalfunctionAug 22, 2022Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS LOADING ISSUE AND THE INTRAOCULAR LENS (IOL) TORE DURING LOADING. THE LENS WAS FULLY INSERTED INTO THE PATIENT'S LEFT EYE; HOWEVER, IT WAS REMOVED DURING THE SAME PROCEDURE. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT IOL. THE ORIGINAL LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15268133 ↗
• MalfunctionApr 15, 2022Break; Break

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED AND HAD TO BE REMOVED AND REPLACED WITH A BACK UP LENS DUE TO BROKEN HAPTIC. THE REPLACEMENT LENS IS THE SAME MODEL AND DIOPTER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14119592 ↗
• MalfunctionFeb 16, 2022Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT WHEN INSERTING AN INTRAOCULAR LENS (IOL) IN A PATIENT'S RIGHT EYE, THE CARTRIDGE TIP ONLY HAD CONTACT WHEN THEY NOTICED THE HAPTIC WAS BENT. IT WAS INDICATED THAT THE LENS WAS STUCK IN THE CARTRIDGE. THE DOCTOR REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER JOHNSON & JOHNSON LENS WITH THE SAME MODEL AND DIOPTER. THERE WERE NO SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED. THE PATIENT WAS REPORTED TO BE DOING OK POST OPERATION AND NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13539849 ↗
• MalfunctionAug 12, 2021Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT A TECNIS INTRAOCULAR LENS (IOL) BACK HAPTIC WAS BENT/BROKEN WHEN LOADING IN THE CARTRIDGE. THERE WAS PATIENT INVOLVEMENT. THE LENS WAS NOT INSERTED AND THE PROCEDURE WAS COMPLETED USING A BACK UP LENS. REPORTEDLY, THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12317100 ↗
• MalfunctionJun 29, 2021Break; Break

  IT WAS REPORTED THAT ONE HAPTIC BROKE DURING UNFOLDING OF THE LENS IN THE EYE. LENS WAS REMOVED IN THE SAME PROCEDURE. CUSTOMER DESTROYED THE LENS. NO MEDICAL INTERVENTIONS WERE REPORTED. THERE WAS A 5-10 MINUTE DELAY IN PROCEDURE. PATIENT FULLY RECOVERED. PATIENT DETAILS WERE NOT PROVIDED ON THE INTAKE FORM DUE TO DATA PROTECTION POLICY. THROUGH FOLLOW UP IT WAS CONFIRMED THAT THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A NEW LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089285 ↗
• MalfunctionApr 21, 2021Break; Failure to Fold; Break; Failure to Fold

  RECEIVED REPORT INDICATING THE INTRAOCULAR LENS (IOL) FOLDED AFTER INSERTION INTO THE EYE AND THE HAPTIC KINKED. THE IOL WAS REMOVED AND REPLACED WITH A SAME MODEL AND DIOPTER LENS. THE INCISION WAS ENLARGED AND SUTURES WERE USED. THE PATIENT IS DOING WELL POST-OP. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 11704736 ↗
• MalfunctionFeb 3, 2021Break; Break

  IT WAS REPORTED THAT A TECNIS INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND REMOVED FROM THE PATIENT'S LEFT (OS) EYE BECAUSE OF A BENT/BROKEN HAPTIC. THE REPLACEMENT LENS IS THE SAME MODEL AND DIOPTER. THE PATIENT HAS RECOVERED AND NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273836 ↗
• MalfunctionJan 11, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO PATIENT'S LEFT EYE. THE DOCTOR NOTICED A BENT IN THE TRAILING HAPTIC AFTER THE LENS INSERTION. THE LENS WAS THEN REMOVED REQUIRING INCISION ENLARGEMENT, AND A NEW LENS WAS IMPLANTED. CURRENT PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11152968 ↗