TECNIS CL IOL Z9002 (REF Z900200200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 05050474530690), received between Oct 17, 2016 and Apr 28, 2022 — classified as 20 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S OPERATIVE EYE; HOWEVER, IT WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE AS THERE WAS A SCRATCH ON THE LENS NEAR THE HAPTIC. ACCOUNT PROVIDED THAT THE IOL WAS CUT OUT DURING THE REMOVAL PROCESS. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT IOL. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14246358 ↗
• InjuryMar 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ACCOUNT REPORTED HAPTIC FIXATION AND DISLOCATED INTRAOCULAR LENS (IOL) IN THE LEFT EYE OF A PATIENT. THE LENS WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE. IT WAS INDICATED THAT A VITRECTOMY WAS PERFORMED, AND SUTURE WAS USED. A COMPETITOR LENS WAS USED AS THE REPLACEMENT AND THE PATIENT IS DOING FINE POST OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 13904666 ↗
• InjuryMar 15, 2022Break; Break

  IT WAS REPORTED THAT THE TRAILING HAPTIC WAS NOTICED TO BE BENT AFTER FULL INSERTION OF THE INTRAOCULAR LENS (IOL) INTO PATIENT'S LEFT EYE. THE INCISION WAS ENLARGED AND ANOTHER JOHNSON & JOHNSON LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT AFTER REMOVING THE ORIGINAL LENS. SUTURE WAS PLACED. HOWEVER, THERE WAS NO PATIENT INJURY. THE PATIENT WAS DOING FINE POST OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 13765165 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INTRAOCULAR LENS (IOL) EXCHANGED DUE TO MYOPIC REFRACTIVE ERROR IN HER RIGHT (OD) EYE. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED DURING THE SECONDARY PROCEDURE. THERE WAS NO COMPLICATIONS. REPORTEDLY, THE PATIENT IS DOING FINE POST-SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 13528666 ↗
• MalfunctionJan 11, 2022Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) TORE UPON INSERTION INTO PATIENT'S OPERATIVE EYE. THE LENS WAS REMOVED DURING THE SAME PROCEDURE. THE PATIENT¿S DAILY ACTIVITIES WERE NOT AFFECTED AND THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13216663 ↗
• MalfunctionDec 8, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT'S LEFT EYE AS THE SURGEON THOUGHT THE LENS HAD A TEAR. HOWEVER, THE SURGICAL TECHNICIAN DID NOT OBSERVE ANY TEAR ON IT. MOREOVER, THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING FINE POST-OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12965467 ↗
• InjuryOct 7, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE EYE AFFECTED WAS LEFT. THE ORIGINAL LENS WAS CAREFULLY CUT OUT USING AN ADDITIONAL SYRINGE OF VISCOELASTIC DURING THE SAME PROCEDURE AND ANOTHER LENS OF SAME MODEL AND DIOPTER (SN (B)(6)) WAS USED AS THE REPLACEMENT. THE PATIENT HAD MILD CORNEAL ENDOTHELIAL TRAUMA. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12595163 ↗
• InjurySep 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT COUGHED AND CAPSULE BROKE WHILE Z9002 MODEL INTRAOCULAR LENS(IOL) HAD CONTACT WITH THE PATIENT'S RIGHT EYE. VITRECTOMY AND SUTURES WERE DONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NON JOHNSON AND JOHNSON SURGICAL VISION LENS. SUSPECT PRODUCT WAS DISCARDED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12551128 ↗
• InjuryJul 9, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT A Z9002 MODEL INTRAOCULAR LENS(IOL) WAS PARTIALLY INSERTED INTO PATIENT'S RIGHT EYE AND WAS REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO SCRATCH ON LENS. PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LENS OF SAME MODAL AND DIOPTER. INCISION WAS ENLARGED BUT NO VITRECTOMY OR SUTURES WERE DONE. PATIENT IS DOING WELL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147370 ↗
• MalfunctionJul 6, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER REPORTED A FULLY INSERTED IOL WAS REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO IOL BEING TORN. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125915 ↗
• MalfunctionJun 11, 2021Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD DAMAGED HAPTICS AS THE PLUNGER OVERRODE THE LENS. THE LENS WAS INSERTED IN THE RIGHT EYE AND REMOVED DURING THE SAME-PROCEDURE. THERE WAS NO INCISION ENLARGEMENT. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987493 ↗
• MalfunctionJun 3, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) IOL WAS FULLY INSERTED IN THE PATIENT'S RIGHT EYE AND REPLACED DURING THE SAME PROCEDURE DUE TO TORN IOL. THE PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935398 ↗
• MalfunctionJun 2, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN (B)(4) INTRAOCULAR LENS (IOL) IN THE LEFT EYE (OS) WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE AS THE LENS WAS TORN WHILE INSERTING INTO THE EYE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) AS A REPLACEMENT. THERE WERE NO SURGICAL INTERVENTION REQUIRED, NO VITRECTOMY, SUTURES OR INCISION ENLARGEMENT. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11925779 ↗
• MalfunctionFeb 24, 2021Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL) HAD FOLDING ISSUES AND HAPTIC BENT. THE LENS WAS NOT IMPLANTED IN PATIENT'S EYE. HOWEVER, THERE WAS PATIENT CONTACT DURING HANDLING. NO ADVERSE EFFECT, INJURY OR SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375665 ↗
• MalfunctionJan 14, 2021Break; Break

  IT WAS REPORTED THAT THE TECNIS INTRAOCULAR LENS (IOL) TWISTED AROUND THE INSERTER AND KINKED THE HAPTIC. THERE WAS PATIENT CONTACT, BUT NO INJURY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11174295 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT'S CAPSULE TORN UPON INSERTION OF A TECNIS MONOFOCAL INTEROCULAR LENS (IOL). THE SURGEON REMOVED AND REPLACED THE LENS WITH A NON-JOHNSON AND JOHNSON ANTERIOR LENS DURING THE INITIAL PROCEDURE. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED. PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 11007027 ↗
• MalfunctionOct 16, 2020Material Opacification; Material Opacification

  IT WAS REPORTED THAT AFTER THE TECNIS MONOFOCAL INTRAOCULAR LENS (IOL) IMPLANTED IN THE PATIENT'S RIGHT (OD) EYE IN 2015, THE LENS WAS OBSERVED TO HAVE SOME TYPE OF OPAQUE COATING ON THE SURFACE. THE PATIENT'S VISION IS AFFECTED AND A PLANNED LENS EXCHANGE HAS BEEN SCHEDULED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 10688419 ↗
• InjuryAug 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INITIALLY A MODEL ZCB00 INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT¿S EYE, HOWEVER THE SURGEON CHANGED THE LENS SELECTION AND A MODEL Z9002 IOL, 20.0 DIOPTER WAS THEN INSERTED. A VITRECTOMY WAS REQUIRED AFTER INSERTION OF THIS LENS. THERE WAS NO QUALITY ISSUE REPORTED AGAINST THE Z9002. THROUGH FOLLOW-UP IT WAS LEARNED THE INCISION WAS ENLARGED AND THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE EVENT FOR THE Z9002 LENS AND THE REPORTED VITRECTOMY. A SEPARATE REPORT IS BEING SUBMITTED FOR THE MODEL ZCB00 LENS AND THE REPORTED INCISION ENLARGEMENT.

  Patient problems: Vitrectomy

  MAUDE report 10383090 ↗
• MalfunctionMar 6, 2020Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED Z9002 20.0 DIOPTER INTRAOCULAR LENS (IOL) DID NOT UNFOLD CORRECTLY ONCE INSERTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THERE WAS NO INCISION ENLARGEMENT AND THE LENS IS NOT BEING RETURNED AS IT WAS DISCARDED. THROUGH FOLLOW UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THERE WAS NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), DID NOT BELIEVE UNPLANNED VITRECTOMY OCCURRED, AND THE SAME PROCEDURE WAS COMPLETED USING BACK-UP LENS WITH THE SAME MODEL AND DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9801365 ↗
• InjuryAug 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL Z9002 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO RESIDUAL REFRACTIVE ERROR. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY OR SUTURES REQUIRED. THE LENS WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. IT WAS STATED THAT THE PATIENT WAS FINE POST-OP, AND THE EXPLANTED LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8886353 ↗
• MalfunctionJul 9, 2019Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material

  IT WAS REPORTED THAT LENS WAS SCRATCHED AND THERE WAS DEBRIS ON THE LENS. REPORTEDLY THERE WAS NO PATIENT CONTACT WITH THE LENS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8770244 ↗
• InjuryApr 27, 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 EXCHANGED. DATE OF SURGERY WAS (B)(6) 2019. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 8558912 ↗
• MalfunctionDec 28, 2018Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF A Z9002 20.0 DIOPTER INTRAOCULAR LENS (IOL) BROKE WHEN INSERTING INTO THE PATIENT'S OPERATIVE EYE. THEREFORE, THE LENS WAS REMOVED AND REPLACED WITH THE SAME MODEL AND DIOPTER LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8205014 ↗
• MalfunctionNov 28, 2018Failure to Eject; Separation Problem; Failure to Eject; Separation Problem

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF A MODEL Z9002, 20.0 DIOPTER INTRAOCULAR LENS (IOL), WHEN BEING INSERTED INTO THE EYE, CAME OFF. THE TRAILING HAPTIC GOT CAUGHT AND STAYED IN THE CARTRIDGE AS THE LENS WAS PLACED IN THE EYE. THERE WAS AN INCISION ENLARGEMENT AND SUTURES. DOCTOR USED THE BACK UP LENS AND THE SURGERY WENT WELL WITH NO PATIENT INJURY REPORTED.

  Patient problems: No Code Available

  MAUDE report 8113630 ↗
• MalfunctionOct 24, 2018Break; Separation Problem; Break; Separation Problem

  IT WAS REPORTED THAT A Z9002 MONOFOCAL INTRAOCULAR LENS HAD A HAPTIC MISSING WHEN REMOVED FROM THE BOX. IT WAS ALSO REPORTED THAT THERE WAS A HAPTIC BENT. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7998427 ↗