TECNIS IOL PCB00 (REF PCB0000165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 05050474558199), received between Sep 1, 2016 and Aug 30, 2023 — classified as 6 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2023Break; Break

  IT WAS REPORTED THAT WHILE TRYING TO IMPLANT THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, A PIECE OF THE LENS BROKE OFF INTO THE EYE. THE SURGEON REMOVED THE LENS PIECES, MAKING SURE NO REMNANTS WERE LEFT IN THE PATIENT'S EYE. A NEW LENS WAS IMPLANTED. THROUGH FOLLOW-UP WE LEARNED THAT THERE WAS A TEN (10) MINUTES DELAY IN THE PROCEDURE. THE THE DIRECTIONS FOR USE (DFU) WHERE FOLLOWED AND NO OTHER INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17656504 ↗
• MalfunctionJul 21, 2022Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) GOT TWISTED IN THE SHOOTER. IT IS UNKNOWN IF THERE WAS PATIENT CONTACT WITH THE PRODUCT. THE MATERIAL IS NOT AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080560 ↗
• MalfunctionDec 27, 2021Difficult to Fold, Unfold or Collapse; Inaccurate Delivery; Failure to Advance; Difficult to Fold, Unfold or Collapse; Inaccurate Delivery; Failure to Advance

  IT WAS REPORTED THAT AFTER IMPLANTATION ACCORDING TO THE DFU (DIRECTIONS FOR USE), THE LAST PUSH WAS GIVEN AND THE TRAILING HAPTIC UNFOLDED AND STAYED IN THE CARTRIDGE. THE HAPTIC WAS NOT FOLDED ON THE OPTIC OF THE LENS AND THE DOCTORS GOT IT OUT OF THE CARTRIDGE WITHOUT DAMAGE, REQUIRING A SECONDARY TOOL TO FREE THE LENS. THERE WAS A DELAY IN PROCEDURE; HOWEVER, NO PATIENT ISSUES REPORTED AND NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13091098 ↗
• MalfunctionJul 15, 2021Break; Failure to Advance; Material Split, Cut or Torn; Break; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) HAD A LOADING ISSUE. THE IOL GOT TORN AND WAS SEVERED IN HALF. ADDITIONALLY, THE IOL WOULD NOT ADVANCE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178416 ↗
• MalfunctionJul 15, 2021Break; Failure to Advance; Operating System Becomes Nonfunctional; Break; Failure to Advance; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE PRELOADED LENS (PCB00) HAD LOADING ISSUE. THE CARTRIDGE BROKE/CRACKED, AND MALFUNCTIONED, WOULD NOT TURN TO LOAD THE LENS. THERE WAS NO PATIENT CONTACT. THE EVENT WAS OBSERVED DURING HANDLING BUT PRIOR TO INSERTION. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171982 ↗
• MalfunctionJul 13, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) DID NOT DISPENSE PROPERLY THAT IT DID NOT UNFOLD WHEN INSERTED INTO PATIENT'S RIGHT EYE. THE SURGEON ATTEMPTED TO MANEUVER BUT WAS UNSUCCESSFUL. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL OF SAME MODEL AND DIOPTER. NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS REPORTEDLY DOING GOOD POST SURGERY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163589 ↗
• MalfunctionMar 18, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE. IT WAS FROM A PRELOADED PRODUCT. PROVISC USED DID NOT HAVE CONTACT WITH PATIENT. SURGERY WAS COMPLETED WITH ANOTHER LENS. APPARENTLY, THE DEFECT WAS NOT SPECIFICALLY KNOWN BY THE CONTACT PERSON WHEN FOLLOW-UP WAS DONE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11520168 ↗
• MalfunctionJan 7, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DROPPED OR WAS A DAMAGED LENS. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, IT WAS LEARNED THE CUSTOMER NO LONGER HAD ANY INFORMATION AVAILABLE AS ALL THE INFORMATION WAS ON THE LENS BOX THAT WAS RETURNED BACK TO JOHNSON & JOHNSON SURGICAL VISION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11129237 ↗
• MalfunctionJan 6, 2021Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT THE CARTRIDGE WAS BROKEN/CRACKED AND THAT THE LENS WAS SCRATCHED WHICH OCCURRED WHILE INSERTING THE LENS INTO THE LEFT EYE OF THE PATIENT. THE LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. THERE WAS NO INCISION ENLARGEMENT REQUIRED. REPORTEDLY THE PATIENT RECOVERED. IT WAS NOTED THAT THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11127207 ↗
• MalfunctionJan 7, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRELOADED INTRAOCULAR LENS WAS CONTAMINATED AND THERE WAS NO PATIENT CONTACT WITH THE LENS. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT THE CONTAMINATION WAS OBSERVED WHILE REMOVING LENS FROM THE OUTER PACKAGE AS THE INNER POUCH HAD A SMALL HOLE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9556445 ↗
• MalfunctionMar 28, 2019Failure to Eject; Physical Resistance/Sticking; Failure to Eject; Physical Resistance/Sticking

  IT WAS INITIALLY REPORTED THAT PRELOADED INTRAOCULAR LENS (IOL) HAD HAPTIC STUCK TO HAPTIC AND HAPTIC STUCK IN INJECTOR ISSUE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE PRELOADED LENS MADE CONTACT WITH THE EYE. THERE WAS NO PATIENT INJURY. NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES WERE REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8461473 ↗
• MalfunctionMar 27, 2019Deformation Due to Compressive Stress; Appropriate Device Problem Term/Code Not Available; Deformation Due to Compressive Stress; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING PRODUCT HANDLING AND PRIOR TO INSERTION OF PCB00 16.5 DIOPTER INTRAOCULAR LENS (IOL) THE PRELOADED INSERTER WAS DAMAGED. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CLARIFYING REPORTED INSERTER DAMAGE AS THE PLUNGER SPLIT THE CARTRIDGE. IT WAS CONFIRMED THE CARTRIDGE TIP WAS DAMAGED AFTER THE PLUNGER SPLIT THE CARTRIDGE, AND THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS WITH THE SAME MODEL AND DIOPTER SIZE. THERE IS NO PATIENT CONTACT REPORTED WITH THE DAMAGED DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 8458363 ↗
• InjuryMar 25, 2019Contamination; Scratched Material; Contamination; Scratched Material

  IT WAS REPORTED THAT THE IMPLANTATION OF THE INTRAOCULAR LENS (MODEL PCB00) INTO THE LEFT EYE (OS) OF THE PATIENT, WENT WELL. REPORTEDLY, WHEN THE LENS WAS IN THE EYE, THE DOCTOR DISCOVERED A STAIN / SCRATCH ON THE CENTER OF THE OPTIC AND DECIDED TO REMOVE THE LENS AND REPLACE IT WITH A NEW PCB00, SAME DIOPTER SIZE. THE INCISION HAD TO BE ENLARGED TO REMOVE THE LENS AND THE PROCEDURE WAS DELAYED BY ABOUT 20 MINUTES. NO VITRECTOMY WAS REQUIRED AND NO FURTHER PROCEDURES WERE PERFORMED OR PLANNED. ONE DAY POST-OP, REMAINING EDEMA WAS OBSERVED IN THE INCISION-AREA. REFRACTION: -2,25 -1,25 131, VISUAL ACUITY 0.63. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; No Code Available

  MAUDE report 8447487 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE EYE DID NOT SUPPORT THE LENS MODEL PCB00 MONOFOCAL IOL (INTRAOCULAR LENS). LENS FELL BACK INTO THE EYE. AS A RESULT, DOCTOR HAD TO REMOVE THE LENS AND PERFORMED A VITRECTOMY. PROCEDURE WAS COMPLETED SUCCESSFULLY USING IOL ZA9003 +17.0 DIOPTER. IT WAS ALSO NOTED THAT PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 8406171 ↗
• MalfunctionFeb 12, 2019Material Split, Cut or Torn; Separation Problem; Material Split, Cut or Torn; Separation Problem

  IT WAS REPORTED THAT THE PCB00 MONOFOCAL IOL (INTRAOCULAR LENS) HAD ONLY ONE (1) HAPTIC. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE TORN HAPTIC WAS IDENTIFIED IN THE PATIENT'S EYE DURING IMPLANTATION. REPORTEDLY, THE LENS AND THE TORN HAPTIC WERE REMOVED AND ANOTHER LENS WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO SIGNIFICANT DELAY AND PATIENT OUTCOME WAS REPORTED AS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8331132 ↗
• MalfunctionFeb 11, 2019Break; Break

  IT WAS REPORTED THAT HAPTIC BROKE OFF FROM PRELOADED INTRAOCULAR LENS WHILE INSERTING. THERE WAS PATIENT CONTACT WITH THE LENS. REPORTEDLY THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY REQUIRED. PATIENT WAS DOING FINE WHEN DISCHARGED. THE COMPLAINT LENS WAS DISCARDED BY THE SURGERY CENTER. NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 8326630 ↗
• MalfunctionJan 17, 2019Contamination; Contamination

  IT WAS REPORTED BY THE SURGEON THAT A PCB00 INTRAOCULAR LENS (IOL) DURING HANDLING, BUT PRIOR TO INSERTION HAD A BLACK HAIR OR FIBER IN THE CARTRIDGE. IT WAS ALSO STATED THAT THERE WAS NO ADVERSE EVENT, SURGICAL INTERVENTION OR PATIENT INJURY INVOLVED IN THIS EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8259229 ↗
• MalfunctionJan 2, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT FAULTY LENSES WERE OBSERVED WHEN REMOVING FROM PACKAGING. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT IS 2 OF 2.

  Patient problems: No Patient Involvement

  MAUDE report 8211004 ↗
• InjuryDec 31, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT TRAILING HAPTIC OF MODEL PCB00 TECNIS MONOFOCAL IOL (INTRAOCULAR LENS) WAS MISSING AFTER IT WAS IMPLANTED IN PATIENT'S RIGHT EYE (OD). AS A RESULT, LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. IT WAS NOTED ALSO THAT THERE WAS INCISION ENLARGEMENT AND THERE WAS SUTURE REQUIRED, BUT THERE WAS NO VITRECTOMY PERFORMED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8207286 ↗
• MalfunctionDec 20, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT MODEL PCB00 TECNIS MONOFOCAL IOL (INTRAOCULAR LENS) WAS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT, THE IOL WAS NOT USED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8186556 ↗
• InjuryNov 28, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT TECNIS PRELOADED MONOFOCAL INTRAOCULAR LENS (MODEL PCB00, +16.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN A SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING SPECIFIC VISUAL ISSUES. REPORTEDLY LENS WITH SAME MODEL, +25.0 DIOPTER, A LARGER DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. PATIENT WAS DOING GOOD. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8113780 ↗
• MalfunctionAug 6, 2018Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE CARTRIDGE OF A PCB00 16.5 DIOPTER LENS TOUCHED THE PATIENT'S OPERATIVE EYE DURING THE INSERTION PROCESS. THE LENS ITSELF WAS NOT IMPLANTED BECAUSE THE SURGEON REALIZED THAT THE LENS WAS STUCK IN THE CARTRIDGE. SURGEON DID NOT WANT TO ADVANCE ON FIRST CLICK LIKE NORMAL. REPORTEDLY, THE HAPTIC WAS BENT, THE LENS OPTIC WAS SCRATCHED, AND WAS INDICATED NOT TO BE DUE TO A USE ERROR. A NEW LENS OF THE SAME MODEL AND DIOPTER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY AND THE PATIENT'S IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7753706 ↗
• MalfunctionJun 21, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED BY THE CUSTOMER THAT AN INTRAOCULAR LENS (IOL) HAD ONE HAPTIC MISSING. THERE WAS PATIENT CONTACT WITH THE PRODUCT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: No Information

  MAUDE report 7624603 ↗
• InjuryMay 3, 2018Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A MISSING HAPTIC. THE IOL WAS REMOVED FROM THE EYE AND THE INCISION WAS ENLARGED. SUTURES WERE NOT USED. ANOTHER IOL OF THE SAME MODEL WAS USED WITHOUT A PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: No Code Available

  MAUDE report 7482170 ↗
• MalfunctionApr 16, 2018Material Frayed; Material Frayed

  IT WAS REPORTED THAT DOCTOR HAD HARD TIME PUSHING THE INJECTOR OF TECNIS ITEC PRELOADED 1-PIECE INTRAOCULAR LENS (IOL) DEVICE AND THE INJECTOR TIP LOOKS A FRAYED AT THE END. THE LENS WAS DELIVERED INTO PATIENT'S EYE AND THE PATIENT IS DOING FINE. NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7435339 ↗