TECNIS IOL PCB00 (REF PCB0000245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 05050474558359), received between Sep 12, 2016 and Oct 16, 2025 — classified as 22 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 67 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) THAT WAS IMPLANTED ON (B)(6) 2021 IS NOW FULLY OPACIFIED. THROUGH FOLLOW-UP, WE LEARNED THAT THE OPACIFICATION WAS NOTICED ON (B)(6) 2025. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS WERE PERFORMED. THE ACCOUNT STATED THAT THE OPACIFICATION IMPAIRS THE PATIENT'S VISION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 23319009 ↗
• MalfunctionSep 3, 2024Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130516 ↗
• MalfunctionApr 8, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE INJECTION OF THE PRELOADED INTRAOCULAR LENS (IOL), ONCE IN THE PATIENT'S EYE, THE LENS APPEARED WITHOUT THE PROXIMAL HAPTIC. THE PROXIMAL HAPTIC WAS INSIDE THE CARTRIDGE AFTER LENS INJECTION. THE INCISION WAS WIDENED AND THE LENS WAS REPLACED WITH A NEW IOL, WHICH LENGTHENED SURGERY TIME. NO ADDITIONAL INFORMATION WAS RECEIVED.

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

  MAUDE report 19068246 ↗
• MalfunctionMar 13, 2023Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS CRACKED. THERE WAS NO PATIENT CONTACT WITH THE DEVICE, AS THE EVENT WAS OBSERVED DURING HANDLING/PRIOR TO INSERTION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16531548 ↗
• MalfunctionDec 10, 2022Contamination; Contamination

  IT WAS REPORTED THAT WHEN IMPLANTING THE LENS, THE DOCTOR NOTICED A BLACK HAIR STUCK TO THE LENS. HE REMOVED IT FROM THE EYE WITH TWEEZERS AND LEFT THE LENS IMPLANTED. THROUGH FOLLOW-UP WE LEARNED THAT TWO HAIRS WERE REMOVED, ONE THE SIZE OF THE LENS DIAMETER INSIDE THE FOLDING OF THE LENS AND ANOTHER HALF THE SIZE OF THE LENS DIAMETER. NO SURGICAL INTERVENTIONS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15955931 ↗
• MalfunctionDec 5, 2022Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam

  IT WAS REPORTED THAT DURING THE INSERTION OF THE LENS ONE OF THE HAPTICS BROKE OFF AND WAS STUCK TO THE INJECTOR. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921823 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A DEFECTIVE PRELOADED INTRAOCULAR LENS (IOL). NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15814282 ↗
• MalfunctionJun 7, 2022Break; Break

  IT WAS REPORTED THAT THE UNIT WAS OPENED BUT WAS NOT USED BECAUSE THE HAPTIC WAS DAMAGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14627052 ↗
• MalfunctionMay 11, 2022Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT AFTER THE PRELOADED INTRAOCULAR LENS (IOL) HAD BEEN IMPLANTED INTO THE EYE, THE SURGEON DISCOVERED A CRACK ON THE ACTUAL LENS. FURTHER INFORMATION RECEIVED ON MAY 4TH INDICATED THAT THE LENS REMAINS IMPLANTED, AS THE SURGEON DECIDED TO LEAVE THE LENS IN SITU BECAUSE THE CRACK WAS AT THE VERY EDGE AND WOULD NOT AFFECT SIGHT GREATLY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366250 ↗
• MalfunctionOct 25, 2021Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT AN PCB00 PRELOADED INTRAOCULAR LENS (IOL) HAS MALFUNCTIONED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12694477 ↗
• MalfunctionAug 11, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) DID NOT COME OUT CORRECTLY AND DID NOT DEPLOY. THE EVENT OCCURRED DURING SURGERY AND CUSTOMER THINKS THERE WAS PATIENT CONTACT, BUT IS NOT SURE ABOUT THE EXTENT OF PATIENT CONTACT. HOWEVER, THERE WAS NO PATIENT INJURY AND NO INTERVENTIONS WERE REQUIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF SAME MODEL AND DIOPTER (SN(B)(4)). NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310898 ↗
• MalfunctionJul 15, 2021Crack; Material Too Rigid or Stiff; Crack; Material Too Rigid or Stiff

  CUSTOMER REPORTED THAT WHILE PREPARING TO INSERT THE INTRAOCULAR LENS (IOL), THE SURGEON NOTICED THE ROD WAS DIFFICULT TO TURN. UPON EXAMINING THE CARTRIDGE TIP, THE PRODUCT WAS DETERMINED TO BE UNUSABLE. IT WAS INDICATED THAT THE CARTRIDGE TIP TOUCHED THE PATIENT''S EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177569 ↗
• InjuryJul 9, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) WAS MISSING WHEN THE PHYSICIAN WENT TO INSERT IT IN THE PATIENT'S EYE. THERE WAS NO IOL IN THE CARTRIDGE. WHILE THE SURGEON WAS TRYING TO INSERT THE IOL, THE PUSHROD CAME IN CONTACT WITH THE PATIENT'S EYE AND BROKE THE POSTERIOR CAPSULE. HOWEVER, THE SURGEON DID NOT REALIZE THAT THE BAG BROKE. HE INSERTED THE BACK-UP PCB00 AND THAT WAS WHEN HE DISCOVERED THAT THE POSTERIOR CAPSULE HAD TORN EVEN BEFORE HE INSERTED THE BACK-UP IOL. HE THEN RETRIEVED THE BACK-UP PRELOADED IOL, DID VITRECTOMY AND REPLACED THE BACK-UP IOL WITH A NON JOHNSON AND JOHNSON IOL. THERE WAS NO INCISION ENLARGEMENT OR SUTURES REQUIRED. THE SURGERY WENT WELL POST-OP, PATIENT WAS FINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 12147956 ↗
• InjuryMay 28, 2021Material Fragmentation; Material Fragmentation

  DURING THE INJECTION OF THE INTRAOCULAR LENS INTO THE PATIENT¿S EYE, THE LENS APPEARED WITHOUT A HAPTIC LOOP. THE HAPTIC LOOP WAS INSIDE THE INJECTOR AND DETACHED FROM THE LENS. THE LENS HAD TO BE CUT TO BE EXPLANTED. THERE WAS A 15 MINUTE DELAY AS THE PATIENT HAD AN IRIS EMORRAGY (HEMORRHAGE), NO OTHER LENS CAN BE IMPLANTED. AN INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. A VITRECTOMY WAS INDICATED AS PROBABLY BEING NEEDED THE NEXT DAY. THE DEVICE WAS NOTED NOT AVAILABLE FOR INVESTIGATION. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Injury; Hyphema

  MAUDE report 11899640 ↗
• MalfunctionApr 12, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) OPENED INSIDE THE RIGHT EYE AND THE SURGEON OBSERVED THAT ONE OF THE HAPTICS WAS BROKEN. THE SURGEON HAD TO CUT THE IOL TO REMOVE IT FROM THE PATIENT'S EYE. THE LENS WAS DISCARDED. THERE WAS NO PATIENT INJURY. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648506 ↗
• MalfunctionMar 18, 2021Break; Break

  THE SURGERY CENTER REPORTED DEFECTIVE INTRAOCULAR LENS (IOL). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11510487 ↗
• MalfunctionFeb 5, 2021Break; Operating System Becomes Nonfunctional; Break; Operating System Becomes Nonfunctional

  IT WAS REPORTED THE LENS WAS DAMAGED AND SHOOTER WOULD NOT WORK. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION REGARDING COMPLAINT HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THIS EVENT THE CASE WILL BE REOPENED AND PROCESSED ACCORDINGLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11286191 ↗
• MalfunctionJan 20, 2021Break; Break

  IT WAS REPORTED THAT THE CUSTOMER HAS A FAULTY LENS, NO PATIENT INVOLVEMENT REPORTED. AFTER SEVERAL FOLLOW-UP NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11206174 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS INSERTED INTO PATIENT'S LEFT EYE AND WAS CUT OUT DUE TO A SULCUS LENS BEING NEEDED. THERE WAS NO DAMAGE TO PATIENT DUE TO LENS, HOWEVER, VITRECTOMY WAS PERFORMED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11182474 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REQUIRED A VITRECTOMY WITH AN INTRAOCULAR LENS (IOL) THAT MAY HAVE BEEN FULLY INSERTED AND REMOVED IN THE SAME PROCEDURE. THE LENS WAS DISCARDED. THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Vitrectomy

  MAUDE report 11025157 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER INSERTION, THE CAPSULE TORE, THE DOCTOR NOTICED VITREOUS COMING AROUND THE LENS. A VITRECTOMY WAS DONE AND THE LENS WAS REMOVED FROM THE PATIENT'S RIGHT EYE. THE PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 10893516 ↗
• InjuryNov 17, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A LOADING ISSUE. THE LENS WAS PARTIALLY INSERTED AND REMOVED IN THE SAME PROCEDURE AS THE SURGEON HAD TO CUT THE HAPTIC OUT FROM THE PATIENTS RIGHT EYE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. PATIENT POST-OPERATIVE (OP) STATUS DAY 1 WAS 20/250 VISUAL ACUITY (VA) DUE TO CORNEAL EDEMA. THROUGH FOLLOW-UP, IT WAS LEARNED THE CORNEAL EDEMA DID NOT RESOLVE WITHIN THE 2 WEEKS POST-OP. AT 4 WEEKS POST-OP RESIDUAL EDEMA PERSISTS, VISION 20/30. PATIENT HAS A SCHEDULED FOLLOW-UP IN 2 WEEKS. THE PATIENT IS KEPT ON STEROID DROPS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Corneal Edema

  MAUDE report 10857350 ↗
• MalfunctionNov 13, 2020Contamination; Contamination

  IT WAS REPORTED THAT DURING IMPLANTATION A SMALL, WHITE PLASTIC PIECE WAS INTRODUCED INTO THE EYE TOGETHER WITH THE TRAILING HAPTIC. IT WAS REMOVED AND KEPT WITHOUT ANY COMPLICATIONS. NO ISSUES FOR THE PATIENT NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10834661 ↗
• InjuryOct 9, 2020Material Opacification; Material Opacification

  IT WAS REPORTED BY THE SURGEON THAT THE INTRAOCULAR LENS WAS OPAQUE DURING POST OPERATIVE EXAMINATION. THE PATIENT HAS AN ASSOCIATED DISEASE - DIABETICS RETINOPATHY. THE PATIENT IS HAVING VISUAL ACUITY ¿HANDS MOVEMENT PERCEPTION¿, WHICH IS A CONSEQUENCE OF DIABETICS RETINOPATHY, AND A VITRECTOMY WILL BE PERFORMED FOR SILICONE OIL INSERTION DUE TO THIS ISSUE. THE PATIENT CONDITION AND VISUAL ACUITY WILL BE EVALUATED AFTERWARDS TO DECIDE IF THE LENS EXPLANT IS NECESSARY. THE RETINA OF THE PATIENT IS CURRENTLY INJURED AND THE EXPLANT OF THE OPAQUE LENS WILL BE JUSTIFIED ONLY AFTER PATIENT RECOVERS HIS VISUAL ACUITY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 10659790 ↗
• InjuryApr 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT HAD UNDERGONE BILATERAL INTRAOCULAR LENS (IOLS) IMPLANTS IN 2016. THE PATIENT IS CURRENTLY EXPERIENCING INTRAOCULAR PRESSURE AND BLURRY VISION. SHE CLAIMS THAT SHE IS ALMOST BLIND IN HER RIGHT EYE ALL THE OBJECTS LOOK SMALL AND VERY BRIGHT. PATIENT HAD PREVIOUS LASIK SURGERY IN BOTH EYES AND AFTER THE PROCEDURE, THE DOCTOR DECIDED SHE WOULD BE A GOOD CANDIDATE TO HAVE IOLS IMPLANTED. SHE WOULD LIKE THEM TO BE REMOVED BUT THE DOCTOR INFORMED HER THAT IT IS NOT POSSIBLE. IT WAS LEARNED THAT INITIALLY THE PATIENT¿S VISION WAS GREAT, HOWEVER, A FEW DAYS LATER SHE SEES "FIBEROPTIC LIGHTS" FLOATING EVERYWHERE IN BOTH EYES (OU). SHE FEELS THAT IT'S ALWAYS TOO BRIGHT. SHE MUST WEAR SUNGLASSES TO BE ABLE TO DRIVE, BUT CAUTIOUSLY. SHE WOULD RATHER DRIVE WHEN IT'S CLOUDY, SO SHE WON¿T HAVE TO WEAR HER SUNGLASSES. THE PATIENT REPORTS SHE HAS HEADACHES AND SHE WENT TO ANOTHER DOCTOR WHO SAID THAT HER EYE PRESSURE WAS TOO HIGH. PRESSURE IN THE RIGHT EYE IS 40 AND THE LEFT EYE IS 60. SHE WAS GIVEN MEDICATIONS FOR THE PRESSURE AND THEY HELPED A BIT. SHE KEPT GOING BACK AND FORTH WITH THE SURGEON WHO SAID THAT SHE HAS IRITIS. SHE WAS GIVEN MEDICATIONS WHICH PRO

  Patient problems: Blurred Vision; Intraocular Pressure Increased; Visual Disturbances

  MAUDE report 9931528 ↗