TECNIS IOL PCB00 (REF PCB0000150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 05050474558168), received between Sep 26, 2016 and Jul 23, 2021 — classified as 12 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A PCB00 INTRAOCULAR LENS (IOL), ONE OF THE HANDLES (HAPTIC) STAYED FOLDED IN THE WRONG POSITION AND CAME OUT IN THE Z POSITION. PATIENT WAS PERMANENTLY IMPAIRED. THERE WAS NO FURTHER INFORMATION PROVIDED. THIS REPORT IS 5 OF 7.

  Patient problems: Eye Injury

  MAUDE report 12222353 ↗
• MalfunctionJul 9, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) WOULD NOT EJECT FROM THE INSERTER. THERE WAS A PATIENT CONTACT AND CARTRIDGE TIP CONTACTS THE PATIENT EYE. ADDITIONAL DETAILS RECEIVED CONFIRMS THAT THERE WAS DAMAGE TO THE LENS. NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE DONE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147794 ↗
• MalfunctionJun 4, 2021Material Fragmentation; Material Fragmentation

  THE ACCOUNT REPORTED OF MISSING HAPTIC ON AN INTRAOCULAR LENS (IOL). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11943616 ↗
• MalfunctionApr 21, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT SURGEON JUST IMPLANTED A MODEL PCB00 INTRAOCULAR LENS (IOL) AND ONE OF THE HAPTICS WAS BROKEN OFF. THE SURGEON ENDED UP HAVING TO EXPLANT THE LENS AND IT WAS DISCARDED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698693 ↗
• MalfunctionMar 18, 2021Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT THE LEADING HAPTIC WAS NOT FOLDED CORRECTLY. THERE WAS NO PATIENT CONTACT. THIS EVENT WAS REPORTED DURING HANDLING AND PRIOR TO INSERTION INTO THE EYE. THE DEVICE EVALUATION FOUND THE LENS GOT STUCK AT THE CARTRIDGE TIP AND IT LOOKS TORN;PIECE OF LENS WAS MISSING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11514735 ↗
• MalfunctionDec 24, 2020Contamination; Contamination

  IT WAS REPORTED THAT AFTER IMPLANTING THE LENS THE SURGEON SAW A PARTICLE. THIS WAS REMOVED AN RETURNED. NO IMPACT ON THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11070816 ↗
• MalfunctionOct 19, 2020Crack; Premature Activation; Crack; Premature Activation

  IT WAS REPORTED THAT A TECNIS ITEC PRELOADED INTRAOCULAR LENS (IOL) ADVANCED TOO EARLY AND THE TIP OF THE CARTRIDGE WAS FUNKY. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED DURING THE INITIAL PROCEDURE. THE CUSTOMER INDICATED THAT THE DEVICE WAS DESTROYED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10701857 ↗
• MalfunctionJul 22, 2020Contamination; Contamination

  IT WAS REPORTED THERE WAS DEBRIS ON AN INTRAOCULAR LENS (IOL). A SMALL PIECE OF DEBRIS WAS NOTED ON INSERTION. THE SURGEON WAS ABLE TO IRRIGATE AND ASPIRATE (I/A) IT OFF AND THE CASE WENT WELL. THE LENS REMAINS IMPLANTED. AN INCISION ENLARGEMENT WAS NOT REQUIRED. THERE WAS NO INDICATION OF PATIENT INJURY OR THAT MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10306450 ↗
• MalfunctionMar 11, 2020Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT A MODEL PCB00 INTRAOCULAR LENS (IOL) HAD MODERATE LATHE LINES. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9816453 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PCB00 INTRAOCULAR LENS (IOL) 15.0 DIOPTER WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO THE DIOPTER WAS NOT STRONG ENOUGH. THE IOL WAS REPLACED WITH MODEL ZCB00 16.5 DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT OR SUTURES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9742315 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRAOCULAR LENS WAS NOT IMPLANTED AND WAS WASTED AS VITRECTOMY WAS PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT SURGEON HAD TO CHANGE FOR ANOTHER LENS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 9068907 ↗
• MalfunctionApr 8, 2019Contamination; Contamination

  IT WAS REPORTED THAT PLASTIC FROM THE CARTRIDGE OF A PCB00 INTRAOCULAR LENS INSERTION SYSTEM CAME OUT INTO THE PATIENT'S OPERATIVE EYE WITH THE INTRAOCULAR LENS DURING IMPLANTATION. THE LENS WAS KEPT IN THE OPERATIVE EYE AND THE PLASTIC WAS REMOVED BY IRRIGATION AND ASPIRATION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8494224 ↗
• MalfunctionApr 8, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT A PCB00 15.0 DIOPTER MONOFOCAL LENS WAS PARTIALLY DELIVERED AS THE LENS GOT STUCK IN THE CARTRIDGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8493347 ↗
• MalfunctionMar 10, 2019Break; Break

  IT WAS REPORTED THAT A PCB00 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND WAS NOT IMPLANTED. THERE WAS NO SURGICAL INTERVENTION OR PATIENT INJURY REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8406444 ↗
• MalfunctionDec 5, 2018Break; Break

  IT WAS REPORTED THAT A PRELOADED PCB00 INTRAOCULAR LENS HAD DEFECTIVE DISTORTED HAPTIC. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8131962 ↗
• MalfunctionOct 12, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT INTRAOCULAR LENS HAD A BENT HAPTIC. REPORTEDLY, THE LENS HAD PATIENT CONTACT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7963249 ↗
• InjuryMay 3, 2018Migration or Expulsion of Device; Detachment of Device or Device Component; Migration or Expulsion of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS MISSING THE TRAILING HAPTIC WHEN THE LENS WAS DELIVERED INTO THE LEFT EYE (OS). IOL HAD TO BE EXPLANTED ON (B)(6) 2018. THE LENS REPORTEDLY WASN¿T WELL CENTERED AT THE END OF A ROUTINE CASE. DURING THE IMPLANT, THE DOCTOR COMMENTED THAT HE SAW TWO INTACT HAPTICS. THE CASE WAS OTHERWISE UNEVENTFUL. THE DOCTOR STATED HE WORKED ON LENS CENTRATION FOR ABOUT 10 MINUTES - DURING THE MANIPULATION HE STATED THAT HE CERTAINLY SAW 2 HAPTICS. ON POD1 (POST OP DAY 1) THE PATIENT HAD 20/25 VISION BUT A SIGNIFICANTLY DISPLACED IOL. THINKING A POSTERIOR CAPSULE RUPTURE OCCURRED, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM. AT THIS SECONDARY SURGERY, THE DOCTOR FOUND NO BAG BREAK BUT DID FIND A SEVERED HAPTIC. THE DOCTOR COULD NOT BE CERTAIN THAT A FREE SEVERED HAPTIC WASN¿T IN THE BAG SULCUS. THE LENS WAS DISCARDED; HOWEVER, A PHOTO WAS PROVIDED. THERE WERE NO PATIENT COMPLICATIONS, NO INCISION ENLARGEMENT AND NO VITRECTOMY REQUIRED. THE PATIENT WAS DOING WELL AT THE TIME OF DISCHARGED AND NO PRESCRIPTION WAS GIVEN OUTSIDE THE NORMAL POST-OPERATIVE TREATMENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7482207 ↗
• InjuryMar 19, 2018Device Operates Differently Than Expected; Positioning Problem; Device Operates Differently Than Expected; Positioning Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INJECTED INTO THE PATIENT'S LEFT EYE UPSIDE DOWN. THE SURGEON STATED THAT THE IOL WAS PRE-LOADED IN THE DELIVERY SYSTEM UPSIDE DOWN. THE IOL HAD TO BE FLIPPED INSIDE THE EYE USING TWO INSTRUMENTS. THERE WAS NO VITRECTOMY, NO INCISION ENLARGEMENT AND NO SUTURES WERE REQUIRED. THE IOL REMAINS IMPLANTED. A SLIGHT HEMORRHAGE WAS DETECTED AT THE END OF PROCEDURE. THE SURGEON DOES NOT KNOW IF IT WAS CAUSED BY THE FLIPPING OF THE IOL OR BY OTHER MANIPULATIONS DONE INTRACAMERALLY WITH INSTRUMENTS. THE ISSUE WAS CONTROLLED BEFORE THE END OF THE CASE. MEDICATION WAS PRESCRIBED POST OPERATIVELY. THE PATIENT WAS DOING WELL WHEN DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7351226 ↗
• InjuryDec 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A PATIENT THAT HAD A TECNIS PRELOADED 1-PIECE MONOFOCOL MODEL PCB00 INTRAOCULAR LENS (IOL) IMPLANTED, EXPERIENCED OCCLUSIVE VASCULITIS DUE TO AN ALLERGIC REACTION. THE SURGEON INDICATED THAT THE PATIENT HAD A DELAYED RESPONSE WITH A VANCOMYCIN-LIKE OCCLUSIVE VASCULITIS, BUT THE PATIENT WAS NOT GIVEN ANTIBIOTICS. IMMEDIATELY AFTER SURGERY, PATIENT HAD CYSTOID MACULAR EDEMA (CME) THEN A FEW WEEKS LATER, OCCLUSIVE VASCULITIS, THEN SOME RETINOPATHY THEN THE MACULA BECAME WHITE AND ALL SORTS OF PROBLEMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Macular Edema; No Code Available

  MAUDE report 7098531 ↗
• MalfunctionSep 15, 2017Split; Split

  IT WAS REPORTED THAT UPON REMOVING THE PCB00 15.0 DIOPTER INTRAOCULAR LENS (IOL) AND INJECTOR FROM THE PACKAGE, THE TIP OF THE INJECTOR WAS SPLIT INTO A V SHAPE. THE PRODUCT WAS NOT USED AND ANOTHER WAS OPENED FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6871303 ↗
• InjuryJul 10, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PCB00 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE EARLY AFTERNOON, THEN THE PATIENT RETURNED FOR A SECOND SURGERY LATE AFTERNOON ON THE SAME DAY TO REPLACE THE LENS BECAUSE THE PHYSICIAN REALIZED HE HAD IMPLANTED THE WRONG DIOPTER FOR THE PATIENT. THE LENS WAS REPLACED WITH THE SAME MODEL WITH A HIGHER DIOPTER SIZE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6699771 ↗
• InjuryJun 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A MODEL PCB00 INTRAOCULAR LENS (IOL) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S OPERATIVE EYE. ALTHOUGH, ATTEMPTS WERE MADE, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6629008 ↗
• InjuryApr 14, 2017Detachment Of Device Component; Unintended Movement; Detachment Of Device Component; Unintended Movement

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE TRAILING HAPTIC WAS DETACHED. REPORTEDLY, THE SURGEON HAD TO LEAVE THE LENS IN THE PATIENT'S EYE WITH ONE HAPTIC. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENS WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE BECAUSE ONE HAPTIC WAS MISSING AND THE LENS WAS NOT FULLY CENTERED. REPORTEDLY, THE EXPLANT AND THE REPLACEMENT PROCEDURE OF THE LENS WENT WELL. THE EXPLANTED LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6493662 ↗
• MalfunctionApr 4, 2017Difficult or Delayed Positioning; Positioning Failure; Device Operates Differently Than Expected; Difficult or Delayed Positioning; Positioning Failure; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING IMPLANTATION, AN INTRAOCULAR LENS (IOL) FAILED TO DISCHARGE PROPERLY FROM THE CARTRIDGE. REPORTEDLY, THE LENS WAS REMOVED FROM THE PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6456111 ↗
• MalfunctionMar 29, 2017Crack; Crack

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) CAME OUT OF THE SIDE OF THE CARTRIDGE TIP. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6444903 ↗