TECNIS IOL PCB00 (REF PCB0000175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 05050474558212), received between Sep 12, 2016 and Dec 11, 2024 — classified as 16 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 48 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DUE TO A CAPSULAR TEAR. THROUGH FOLLOW-UP, WE LEARNED THAT DURING THE IMPLANTATION OF THE LENS A PARTIAL DISINSERTION OF THE CRYSTALLINE CAPSULE OCCURRED WITH OPENING OF THE POSTERIOR CAPSULE. THEREFORE, ACCOUNT INDICATED THAT THEY PROCEEDED WITH THE REMOVAL OF THE IOL AND THE IMPLANTATION OF A THREE-PIECE IOL IN THE SULCUS. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Capsular Bag Tear

  MAUDE report 20908700 ↗
• MalfunctionApr 7, 2022Crack; Mechanical Jam; Crack; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD DEPLOYING ISSUE. WHEN ATTEMPTING TO DEPLOY THE LENS, THE INJECTOR BULGED OUTWARDS ON THE SIDE AND THE LENS WAS STUCK VERY CLOSE TO THE TIP WHERE IT BULGED. THERE WAS CONTACT WITH PATIENT'S RIGHT EYE. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THE ACCOUNT USED OPHTHALMIC VISCOELASTIC DEVICE (OVD) WHICH WAS ALLOWED TO ACCLIMATIZE FULLY TO OPERATING ROOM (OR) TEMPERATURE. AFTER INSERTER PREP, THERE WAS A DELAY OF 2-3 MINUTES IN THE SURGERY BEFORE AN ATTEMPT WAS MADE TO ADVANCE THE LENS. THE LENS WAS NOT FULLY DEPLOYED UNTIL HANDED OFF TO DOCTOR. THE LENS INITIALLY MOVED A LITTLE, THEN WAS STUCK WHICH REPORTEDLY LOOKED LIKE THERE WAS A DEFECT WITH CARTRIDGE ITSELF. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14048426 ↗
• MalfunctionMar 15, 2022Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS CRACKED. THERE WAS NO PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED USING ANOTHER LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13766549 ↗
• MalfunctionDec 6, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12942461 ↗
• MalfunctionApr 7, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT A PCB00 INTRAOCULAR LENS (IOL) CARTRIDGE FRACTURED DURING LENS IMPLANTATION, DAMAGING THE LENS. THERE WERE NO COMPLICATIONS, SURGERY COMPLETED. NO ENLARGEMENT OF INCISION. NO SUTURES. THERE WAS PATIENT CONTACT WITH LENS. NO MEDICAL INTERVENTION REQUIRED, NO VITRECTOMY. THERE IS NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627952 ↗
• MalfunctionMar 9, 2021Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DAMAGED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441431 ↗
• MalfunctionFeb 19, 2021Break; Crack; Failure to Advance; Break; Crack; Failure to Advance

  IT WAS REPORTED BY THE CUSTOMER THAT PLUNGER FOR PRELOADED INTRAOCULAR LENS PUSHES THROUGH SIDE OF INJECTOR, NOT PUSHING THE LENS INTO THE EYE. THROUGH FOLLOW UP, ADDITIONAL INFORMATION WAS RECEIVED STATING THE PLUNGER STARTED TO ADVANCE AND THE LENS WOULD NOT ADVANCE AT ALL; IT WAS COMPLETELY STUCK. IT WAS DURING THE INITIAL PHASE OF ADVANCING, SO IT WAS NOT IN ANY PATIENT''S EYE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11349732 ↗
• MalfunctionFeb 10, 2021Inaccurate Delivery; Difficult to Advance; Inaccurate Delivery; Difficult to Advance

  IT WAS REPORTED THAT A PCB00 MODEL INTRAOCULAR LENS(IOL) WAS STUCK HALF IN INCISION AND WAS PARTIALLY INSERTED INTO PATIENT'S RIGHT EYE. THE EVENT WAS OBSERVED WHILE INSERTING LENS INTO EYE. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK LENS AND PATIENT HAS RECOVERED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11309578 ↗
• InjuryFeb 1, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS SCRATCHED. THE LENS WAS INSERTED IN THE LEFT EYE AND REMOVED DURING THE SAME-DAY PROCEDURE. AN INCISION ENLARGEMENT WAS REQUIRED. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. AND THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 11264210 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A POSTERIOR CAPSULE TEAR WITH AN INTRAOCULAR LENS (IOL). HAPTIC/OPTIC MADE CONTACT WITH THE EYE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Capsular Bag Tear

  MAUDE report 11060734 ↗
• InjuryOct 26, 2020Premature Activation; Unintended Movement; Premature Activation; Unintended Movement

  IT WAS REPORTED THAT THE CATARACT SURGERY ON THE LEFT EYE OF THE PATIENT WENT FINE. THE BAG WAS INTACT. WHEN THE LENS WAS PUSHED OUT, IT SNAPPED AND QUICKLY PUSHED FROM ONE LINE TO THE NEXT, EJECTING THE LENS AND PUSHING THE LENS INTO ANTERIOR VITREOUS. IT WAS INDICATED THAT THE LENS WAS CENTERED AND REPOSITIONED IN THE EYE. THE LENS REMAINS IMPLANTED. THERE IS NO PAIN, BUT THE DOCTOR ANTICIPATES DIZZY VISION AND IS EXPECTING TO PERFORM A VITRECTOMY AND AN EXPLANT. THE PATIENT WAS SEEN ON (B)(6) 2020 AND THE DOCTOR''S OBSERVATION AND DIAGNOSIS IS THAT IOL IS TILTED, APPEARS STILL CENTERED. THE NEXT PLAN IS FOLLOW UP IN TWO (2) WEEKS. THERE IS CAPSULE TEAR NOTED. HOWEVER, RIGHT NOW THERE IS NO NEED FOR MEDICAL OR SURGICAL INTERVENTION SUCH AS VITRECTOMY BUT THE PATIENT STILL NEEDS IT IN THE FUTURE. THE PATIENT OUTCOME RIGHT NOW IS TO WAIT UNTIL ONE (1) MONTH AFTER SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 10738291 ↗
• InjuryOct 7, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) WAS INSERTED IN THE PATIENT'S EYE AND WAS THEN REMOVED AS THE IOL FLIPPED. THE SURGEON HAD TO CUT THE LENS UP TO REMOVE IT FROM THE EYE, AND IT WAS REPLACED WITH A BACK-UP IOL OF THE SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY BUT REPORTEDLY SUTURES WERE REQUIRED. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10640097 ↗
• MalfunctionAug 5, 2020Failure to Fold; Failure to Eject; Failure to Fold; Failure to Eject

  IT WAS REPORTED THERE WAS A FOLDING ISSUE WITH A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). THE IOL WAS STUCK IN THE CARTRIDGE AND PARTIALLY INSERTED INTO THE PATIENT'S LEFT (OS) EYE. THE PROCEDURE WAS COMPLETED USING ANOTHER PCB00 IOL OF THE SAME DIOPTER WHICH WAS IMPLANTED. THERE WAS NO SURGICAL INTERVENTION PERFORMED AND PATIENT IS DOING FINE POST-SURGERY. THE CUSTOMER INDICATED THAT THE LENS WAS DISCARDED AND ONLY THE EMPTIED BOX WILL BE RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10371083 ↗
• InjuryJun 30, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT LENS BECAME DISPLACED AFTER OMNI PROCEDURE AND SURGEON DECIDED TO EXPLANT THE LENS FROM PATIENT¿S OPERATIVE EYE IN SECONDARY SURGICAL PROCEDURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10216010 ↗
• MalfunctionMar 11, 2020Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT A PCB00 MODEL INTRAOCULAR LENS(IOL) HAD SLIGHT WIDE GROOVES. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9820502 ↗
• MalfunctionFeb 28, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO THE PATIENT'S RIGHT EYE, IT FAILED TO DEPLOY THE LENS INTO THE LOADER. THERE WAS NO INDICATION OF PATIENT INJURY, OR THAT MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. A NEW LENS WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9767733 ↗
• MalfunctionFeb 13, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT A PCB00 PRELOADED DEVICE INJECTOR MALFUNCTIONED. ADDITIONAL INFORMATION WAS RECEIVED. THE PLUNGER ENGAGED WITH THE LENS, BUT THE SURGEON WAS UNABLE TO ADVANCE THE LENS FULLY OUT OF THE INJECTOR. THE REPORTED EVENT WAS OBSERVED DURING INSERTION INTO THE EYE WITH LENS PARTIALLY INSERTED AND HAD TO BE WITHDRAWN BECAUSE IT WOULDN¿T FULLY EJECT FROM THE CARTRIDGE TIP. THERE WAS NO PATIENT INJURY OR INTERVENTION REQUIRED. PROCEDURE WAS COMPLETED SUCCESSFULLY USING A SECOND LENS OF THE SAME POWER INJECTED THROUGH THE SAME INCISION WITHOUT MODIFICATION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9703949 ↗
• MalfunctionNov 18, 2019Failure to Eject; Failure to Eject

  IT WAS BEEN REPORTED THAT THE LENS WAS DEFECTIVE. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE LENS GOT STUCK IN THE INJECTOR AT THE CARTRIDGE TIP AND HAPTIC/OPTIC CONTACTED PATIENT'S EYE. NO SECONDARY SURGERY/MEDICAL INTERVENTION WAS REQUIRED. THE IOL WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. VISUAL ACUITY (VA) PRE-OP WAS REPORTED AS 0.5, AND POST-OP VA IS 1.0. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9339557 ↗
• InjuryOct 25, 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 EXPLANTED FROM THE PATIENT¿S LEFT EYE. REPORTEDLY, IT WAS A COMPLICATED IOL, AND THE LENS DID NOT CORRECT VISION TO HELP PATIENT NOT NEED GLASSES. LENS FROM ANOTHER MANUFACTURER WAS USED AS REPLACEMENT FOR THE PATIENT. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND NO VITRECTOMY PERFORMED. PATIENT WAS DOING GOOD AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9241343 ↗
• MalfunctionSep 26, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) BECAME STUCK IN THE CARTRIDGE AND HAD PATIENT CONTACT. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9122190 ↗
• MalfunctionSep 11, 2019Break; Failure to Eject; Break; Failure to Eject

  IT WAS REPORTED THAT WHEN INSERTING THE PCB00 INTRAOCULAR LENS (IOL) INTO THE EYE, THE DOCTOR HAD RESISTANCE. THE PROCEDURE WAS COMPLETED USING ANOTHER IOL OF THE SAME MODEL AND THERE WAS NO INTERVENTION REQUIRED. THE PATIENT WAS DOING GREAT POST-OPERATIVELY. REQUESTS WERE MADE FOR ADDITIONAL INFORMATION BUT NO RESPONSE WAS RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8987958 ↗
• InjuryApr 11, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS DEFECTIVE, BUT WITHOUT ANY INDICATION OF WHEN THIS OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 8502466 ↗
• InjuryMar 4, 2019Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE HAPTIC OF THE PCB00 MONOFOCAL IOL (INTRAOCULAR LENS) WAS MISSING AFTER THE IMPLANTATION INTO THE PATIENT'S OPERATIVE EYE. AS A RESULT, THE INCISION WAS ENLARGED, THE LENS REMOVED AND A NEW LENS IMPLANTED AS A REPLACEMENT, DURING THE SAME SURGICAL PROCEDURE. SUTURES WERE ALSO REQUIRED. NO VITRECTOMY WAS PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED AND THE ACCOUNT COMMENTED THAT THEY ARE EXPECTING A NORMAL RECOVERY FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8386173 ↗
• MalfunctionFeb 25, 2019Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT LENS MODEL, PCB00 MONOFOCAL IOL (INTRAOCULAR LENS) DID NOT ADVANCE. THROUGH FOLLOW-UP, THE CARTRIDGE TIP TOUCHED THE PATIENT'S EYE, BUT THERE WAS NO PATIENT INJURY. THERE WAS NO INCISION ENLARGEMENT NOR ANY INJURIES REPORTED. THE LENS WAS STUCK IN THE CARTRIDGE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8368899 ↗
• InjuryFeb 24, 2019Break; Break

  IT WAS REPORTED THAT LENS MODEL, PCB00 MONOFOCAL IOL (INTRAOCULAR LENS) WAS BROKEN WHEN INTRODUCED INTO PATIENT''S EYE. AS A RESULT, LENS WAS REMOVED AND REPLACED WITH THE BACK-UP LENS IN THE SAME PROCEDURE. INCISION WAS ENLARGED IN ORDER TO REMOVE THE IOL FROM THE EYE. VITRECTOMY WAS REQUIRED AS WELL. THE DOCTOR ALSO EXPRESSED DISSATISFACTION AS HE IS NO LONGER HAPPY WITH THE USE OF PCB00 PRELOADED LENS. THROUGH FOLLOW-UP, THERE WAS NO WOUND LEAKAGE, BUT PATIENT HAS SIGNIFICANT OEDEMA. PATIENT''S ANTERIOR CHAMBER (A/C) WAS CLEAR AND DARK AS NO FLARE NOR CELLS WERE OBSERVED. POSTERIOR POLE WAS FLAT WITH HAZY VIEW, DISC & MAC APPEAR WITHIN NORMAL LIMITS. DURING THE SECOND PATIENT''S POST-OP VISIT, HIS EYES ARE QUIET, NO STAIN AND INTRAOCULAR PRESSURE (IOPS) ARE NORMAL AS STATED. PATIENT''S A/CS WERE CLEAR. MIOPS ARE WITHIN NORMAL LIMITS. LT MONOFOCAL IOL IN SITU FOUND NO INFLAMMATION AT INCISION, NO PIGMENTATION, NO POSTER CHAMBER OPACIFICATION (PCO), POSTERIOR POLES WAS FLAT, NO CMO (CYSTOID MACULAR OEDEMA) AND NO UVEITIS. THERE WERE NO CELLS NOR FLARES IN A/CS. REPORTEDLY, PATIENT OUTCOME HAS IMPROVED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Corneal Edema; No Code Available

  MAUDE report 8365054 ↗