TECNIS CL IOL Z9002 (REF Z900200205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 05050474530706), received between Sep 12, 2016 and Apr 6, 2023 — classified as 11 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2023Break; Break

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) HAPTIC WAS DEFECTIVE. IT WAS NOTED THAT THE LENS WAS OPENED AND NOT USED. IT IS UNKNOWN IF THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16696655 ↗
• MalfunctionApr 6, 2023Break; Break

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE. IT WAS NOTED THAT THE LENS WAS OPENED AND NOT USED. IT IS UNKNOWN IF THERE WAS ANY PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16696640 ↗
• MalfunctionJun 9, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) BROKE AS IT WAS ABOUT TO BE PUT IN PATIENT'S OPERATIVE EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14651162 ↗
• MalfunctionMay 13, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) SPLIT IN HALF WHILE INSERTING INTO PATIENT'S OPERATIVE EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14402580 ↗
• MalfunctionApr 29, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) CAME OFF IN THE INJECTOR WHILE BEING ADVANCED INTO PATIENT'S OPERATIVE EYE. THERE WAS CONTACT WITH THE EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14247679 ↗
• MalfunctionApr 15, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND HAD TO BE REMOVED/REPLACED WITH A BACK UP LENS BECAUSE THE IOL WAS TORN. THE REPLACEMENT LENS IS OF A SAME MODEL AND DIOPTER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14123362 ↗
• MalfunctionApr 5, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S RIGHT EYE; HOWEVER, THE IOL WAS REMOVED DURING THE SAME PROCEDURE DUE TO A BENT HAPTIC. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT IOL. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS REPORTEDLY VERY WELL POST OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018136 ↗
• InjuryMar 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE AS THE LENS DECENTERED. THERE WAS NO PATIENT INJURY, HOWEVER, A VITRECTOMY AND IRIDOTOMY WERE PERFORMED. ANOTHER COMPETITOR LENS WAS USED AS THE REPLACEMENT. THE PATIENT'S POST-OPERATIVE OUTCOME WAS NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 13795097 ↗
• MalfunctionMar 16, 2022Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO PATIENT'S RIGHT EYE, HOWEVER, WAS REMOVED DUE TO BENT HAPTIC ISSUE. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. 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 13782287 ↗
• MalfunctionMar 16, 2022Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO PATIENT' RIGHT EYE, HOWEVER, WAS REMOVED AS IT HAD BROKEN HAPTIC. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13781916 ↗
• MalfunctionFeb 3, 2022Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED DURING INSERTION THE INTRAOCULAR LENS (IOL) HAPTIC BROKE AND JAMMED IN THE PSCST30 CARTRIDGE; ACCOUNT STATED POSSIBLE USE ERROR AND FOLDING ISSUE. ANOTHER LENS WITH THE SAME MODEL AND DIOPTER WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THERE WAS NO MEDICAL AND NO SURGICAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13447676 ↗
• MalfunctionJan 28, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO THE PATIENT'S LEFT EYE; HOWEVER, IT WAS REMOVED AS A CRACK WAS NOTICED ON THE LENS WHILE INJECTING INTO THE EYE. ANOTHER IOL OF THE SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT LENS. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE LENS WAS DESTROYED UPON RETRIEVAL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13389066 ↗
• MalfunctionDec 22, 2021Break; Break

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) TRAILING HAPTIC WAS BENT AND THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13066157 ↗
• MalfunctionDec 14, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS(IOL) WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE, THE LENS BROKE UPON INSERTION AND THE SURGEON CUT THE LENS OUT. NO ENLARGEMENT OF WOUND AND NO VITRECTOMY WERE DONE. THERE WAS NO PATIENT INJURY AND ALSO NO SURGICAL/ MEDICAL INTERVENTION WAS DONE. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF SAME MODEL AND DIOPTER. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006952 ↗
• MalfunctionNov 19, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD MARKS ON IOL NOTED WHEN PLACED IN EYE, RELATED TO LOADING. IT WAS LEARNED THAT MARKS WERE NOTED AFTER PLACED IN THE EYE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES DONE. NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849399 ↗
• MalfunctionNov 7, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A Z9002 MODEL INTRAOCULAR LENS(IOL) HAD HAPTIC TORN OFF WHILE LOADING THE LENS. THERE WAS PATIENT CONTACT REPORTED. SUSPECT PRODUCT WAS DISCARDED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12756691 ↗
• MalfunctionNov 6, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) RIPPED OFF DURING LOADING. ACCOUNT PROVIDED THAT THE DEVICE CONTACTED THE PATIENT'S OPERATIVE EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12755973 ↗
• MalfunctionSep 2, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT WHILE THE SURGEON WAS ATTEMPTING TO INSERT A Z9002 MODEL INTRAOCULAR LENS (IOL) INTO PATIENT'S OPERATIVE EYE HE NOTICED A TEAR IN THE HAPTIC. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE SURGERY CONTINUED AS EXPECTED AND THERE WAS NO PROBLEM. ALSO IT WAS STATED BY THE SCRUB TECHNICIAN THAT SHE DID NOT KNOW IF THE TEAR WAS ALREADY THERE OR IF IT HAPPENED WHEN THE DOCTOR WAS ATTEMPTING TO INSERT INTO EYE. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12411988 ↗
• MalfunctionAug 12, 2021Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) BROKE UPON INSERTING INTO THE PATIENT'S LEFT EYE AND WAS REMOVED FROM THE EYE. THE LENS WAS DISCARDED. THE INCISION WAS NOT ENLARGED. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE AND THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316926 ↗
• MalfunctionAug 10, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A Z9002 MODEL INTRAOCULAR LENS(IOL) HAD HAPTIC RIPPED OFF DURING LOADING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305310 ↗
• MalfunctionJul 14, 2021Break; Inaccurate Delivery; Mechanical Jam; Break; Inaccurate Delivery; Mechanical Jam

  IT WAS REPORTED THAT WHILE ATTEMPTING TO INSERT THE INTRAOCULAR LENS (IOL) IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) THE LENS BECAME STUCK IN THE CARTRIDGE. THE HAPTIC WAS BENT AND THERE WAS PATIENT CONTACT. BUT THERE WAS NO PATIENT INJURY. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO UNPLANNED SUTURE(S) AND NO UNPLANNED VITRECTOMY. THE PROCEDURE WAS COMPLETED USING ANOTHER BACK-UP LENS OF A DIFFERENT MODEL AND DIOPTER SIZE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170730 ↗
• MalfunctionJul 14, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A BROKEN HAPTIC AND WAS STUCK IN CARTRIDGE. ISSUE WAS OBSERVED WHEN INSERTING THE IOL INTO THE PATIENT'S EYE. THERE WAS PATIENT CONTACT; HOWEVER, THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES PERFORMED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170489 ↗
• MalfunctionJul 14, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT A Z9002 TECNIS MONOFOCAL 3-PIECE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED AND REMOVED IN THE SAME PROCEDURE DUE TO THE LENS HAVING A BENT HAPTIC. THE LENS WAS REPLACED WITH ANOTHER IOL OF THE SAME MODEL AND DIOPTER. THERE WAS NO MEDICAL INTERVENTION REQUIRED, AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12169696 ↗
• MalfunctionApr 6, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE, THE SURGEON NOTICED THERE WAS NO HAPTIC. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS, SAME MODEL AND DIOPTER IN THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617754 ↗
• MalfunctionFeb 18, 2021Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT A Z9002 MODEL INTRAOCULAR LENS(IOL) WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE AND WAS CUT OUT AS CUSTOMER BELIEVES THAT LENS WAS INSERTED INCORRECTLY. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK UP LENS AND PATIENT WAS DOING OKAY. THIS EVENT WAS OBSERVED AFTER INSERTION OF LENS INTO PATIENT'S EYE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11346215 ↗