TECNIS IOL PCB00 (REF PCB0000250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 05050474558366), received between Nov 18, 2016 and Jul 28, 2023 — classified as 18 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Break” (12 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.

• MalfunctionJul 28, 2023Contamination; Contamination

  IT WAS REPORTED THAT DURING THE SURGERY DAY THE CUSTOMER HAD FIVE CASES OF FOREIGN MATERIAL ENTERING THE EYE DURING IMPLANTATION. PREVIOUS CASES HAD BEEN REPORTED BY THEM AND ON THIS SURGERY DAY, THE CUSTOMER USED HEALON PRO INSTEAD OF THEIR NORMAL (OPHTHALMIC VISCOSURGICAL DEVICE) OVD TO TRY AND EXCLUDE THE OVD AS THE SOURCE OF THE PARTICLE'S THEY ARE SEEING. BECAUSE THE ¿EXTRA MATERIAL¿ WAS STILL OBSERVED, IT WOULD APPEAR THAT THE PRE-LOADED LENS SYSTEM SEEMS TO BE THE SOURCE. NO FURTHER INFORMATION WAS PROVIDED. SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER 4 INCIDENTS ON THE SURGERY DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414326 ↗
• MalfunctionJan 13, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) EJECTED FROM THE CARTRIDGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16165044 ↗
• MalfunctionDec 6, 2022Break; Break

  IT WAS REPORTED THAT THE PHYSICIAN NOTICED A CRACK IN THE PRELOADED LENS. THE ISSUE WAS IDENTIFIED DURING HANDLING AND PRIOR TO INSERTION WITH NO PATIENT CONTACT. THROUGH FOLLOW-UP IT WAS LEARNED THAT THERE WERE NO ISSUES OR COMPLICATIONS FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15928788 ↗
• MalfunctionNov 4, 2022Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAPTIC BROKE DURING IMPLANTATION INTO THE PATIENT'S EYE. THAT HAPTIC STUCKED AT INJECTOR DURING IMPLANTATION INTRAOPERATIVELY AND WAS UNABLE TO PROCEED FURTHER. THUS THE LENS WAS EXPLANTED AND STANDBY SENSAR AR40E LENS WAS IMPLANTED INSTEAD. THE LENS WAS REMOVED AND ANOTHER JOHNSON AND JOHNSON LENS OF A DIFFERENT MODEL (AR40E) WAS USED AS THE REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15733423 ↗
• MalfunctionJun 15, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14706817 ↗
• MalfunctionJun 15, 2022Break; Break

  IT WAS REPORTED THAT THE LENS WAS FAULTY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691878 ↗
• MalfunctionMay 11, 2022Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE PRE-LOADED INTRAOCULAR LENS (IOL) MISFIRED AND WAS NOT USABLE. THE BACK-UP/NEW IMPLANT WAS USED TO FINISH THE PROCEDURE. PATIENT OUTCOME WAS PROVIDED AS NO NEGATIVE IMPACT REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366208 ↗
• InjuryDec 20, 2021Device Difficult to Setup or Prepare; Inaccurate Delivery; Failure to Advance; Scratched Material; Device Difficult to Setup or Prepare; Inaccurate Delivery; Failure to Advance; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS WOULD NOT ADVANCE AND WAS NOT INSERTED. THERE WAS PATIENT CONTACT WITH PATIENT'S LEFT EYE, HOWEVER, COULD NOT CONFIRM IF IT WAS LENS OR JUST THE CARTRIDGE THAT TOUCHED THE EYE. ANOTHER LENS OF SAME MODEL AND DIOPTER ((B)(4)) WAS USED AS THE REPLACEMENT AND A SUTURE WAS PLACED. THE PATIENT WAS FINE POST OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13046374 ↗
• MalfunctionJul 14, 2021Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE SURGEON FOUND A MICRO MARK ON THE OPTIC OF THE INTRAOCULAR LENS (IOL) AFTER BEING IMPLANTED INTO THE PATIENT'S EYE. THE IOL REMAINS IMPLANTED. NO VITRECTOMY, SUTURES, INCISION ENLARGED, MEDICATION OR DELAY IN THE PROCEDURE WAS REPORTED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170411 ↗
• MalfunctionJun 30, 2021Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT A PCB00 LENS WAS DAMAGED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096664 ↗
• MalfunctionJun 24, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD BROKEN HAPTIC. THE INTRAOCULAR LENS (IOL) WAS INSPECTED AND THEN INJECTED INTO THE POSTERIOR CAPSULAR BAG OF PATIENT'S RIGHT EYE. AS THE LENS UNFOLDED, IT WAS NOTED THAT THE HAPTIC WAS BROKEN. ADDITIONAL ENDOCOAT WAS INJECTED INTO THE ANTERIOR CHAMBER AND HEALON WAS INJECTED BEHIND THE LENS IMPLANT. THE LENS WAS DIALED OUT FROM THE BAG. THE CAPSULAR BAG WAS INTACT. ANOTHER SAME MODEL AND POWER IOL WAS INJECTED INTO THE BAG. MST FORCEPS AND SCISSORS WERE USED TO HOLD AND CUT THE DEFECTIVE LENS FROM THE ANTERIOR CHAMBER. THE LENS AND A BROKEN HAPTIC WERE REMOVED THROUGH THE MAIN INCISION. SINGLE INTERRUPTED 10-0 NYLON SUTURE WAS PLACED THROUGH THE MAIN INCISION. THERE WAS A MILD SUBINCISIONAL BLEEDING. MINIMAL AMOUNT OF ENDOCOAT WAS USED TO TAMPONADE IT. THE WOUND WAS GENTLY HYDRATED AND WAS FOUND TO BE WELL-SEALED WITH NO LEAKAGE AS CHECKED WITH A WECK CEL AND BY A DROP OF BETADINE 5% OVER INCISIONS WHICH WAS THEN WASHED OUT WITH NORMAL SALINE. THE EYE WAS OF A NORMAL PHYSIOLOGIC TENSION. THE EYE SPECULUM WAS REMOVED AND A DROP OF VIGAMOX, KETOROLAC, TETRACAINE AND PRED FORTE PLACED INTO THE OPERATIVE EYE FOLLOWED BY THE SHIELD. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063319 ↗
• MalfunctionJun 10, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER IMPLANTED THE 25.0 DIOPTER LENS INTO THE PATIENT'S EYE AND THE LENS SPLIT INTO 3 PARTS AFTER IT WAS IMPLANTED INTO THE EYE ¿ THE SURGEON REMOVED ALL THE PARTS AND CLEANED OUT THE EYE AND RE-INSERTED ANOTHER 25 DIOPTER POWER LENS. LENS INSERTED AND REMOVED AND REPLACED DURING SAME PROCEDURE. THE PATIENT IS FINE AND THE SURGERY WENT WELL AFTER THIS. MATERIAL IS AVAILABLE. IT WAS NOTED THAT THE INCIDENT OCCURRED DURING IMPLANTATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11980718 ↗
• MalfunctionJun 8, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT A PCB00 INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DUE TO A SCRATCHED LENS. THERE WERE NO VITRECTOMY, SUTURES OR MEDICAL/ SURGICAL INTERVENTION REQUIRED. THE PROCEDURE COMPLETED SUCCESSFULLY USING THE SAME MODEL AND DIOPTER. THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963277 ↗
• InjuryMay 14, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ONE HAPTIC OF AN INTRAOCULAR LENS WAS MISSING, THE SURGEON HAD TO REMOVE THE LENS BY CUTTING IT OUT AND IMPLANTING ANOTHER LENS BY FINISHING WITH SUTURE. EVENT WAS OBSERVED DURING IMPLANTATION OR APPLICATION. PATIENT RECOVERED FULLY POST-OP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826377 ↗
• MalfunctionMar 29, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A SURGERY, ONE OF THE HAPTICS FELL OFF COMPLETELY. THE LENS WAS REMOVED FROM THE PATIENT'S EYE AND REPLACED WITH AN AR40E 23.5 LENS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586718 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS IMPLANTED AND EXPLANTED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING IOL WAS EXPLANTED (REMOVED) AFTER A RUPTURE OF THE POSTERIOR CAPSULAR BAG WAS NOTED DURING THE REMOVAL OF VISCOELASTIC. LENS WAS EXPLANTED (REMOVED) WITHOUT DIFFICULTY AND WAS NOT RELATED TO A PRODUCT QUALITY ISSUE. A SULCUS IOL WAS IMPLANTED DURING THE SAME PROCEDURE AFTER ANTERIOR VITRECTOMY WAS PERFORMED. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 10730982 ↗
• MalfunctionSep 20, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL), AND HAPTIC WAS COMING OUT OF THE CARTRIDGE TOO QUICKLY. THE LENS CAME IN CONTACT WITH THE PATIENT PRIOR TO INSERTION. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10558258 ↗
• MalfunctionAug 25, 2020Contamination; Contamination

  IT WAS REPORTED THAT A PCB00 MODEL INTRAOCULAR LENS(IOL) HAD A WHITE PARTICULATE ON THE OPTIC AND IT WAS NOTICED AFTER IMPLANTATION OF LENS INTO PATIENT'S RIGHT EYE. THE SURGEON USED HANDHELD INSTRUMENTS TO DISLODGE AND IRRIGATION ASPIRATION (IA) HANDPIECE TO RETRIEVE THE PARTICLE FROM THE EYE. NO SURGICAL INTERVENTION LIKE INCISION ENLARGEMENT, SUTURES OR VITRECTOMY WERE REQUIRED. THERE WAS A DELAY OF 5 MINUTES IN THE PROCEDURE. IOL STILL REMAINS IMPLANTED IN THE PATIENT EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10451247 ↗
• 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 9931529 ↗
• MalfunctionMar 26, 2020Contamination; Contamination

  IT WAS REPORTED THAT DURING IMPLANTATION THERE WAS OBSERVED A SMALL KIND OF THREAD ON TOP OF THE OPTIC OF THE INTRAOCULAR LENS. THE PIECE OF THREAD LOOKED A BIT BRASSY, AND IT WAS REMOVED FROM THE EYE SUCCESSFULLY, AND THERE WAS NO PATIENT INJURY. EVERYTHING WAS REPORTED AS DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9881813 ↗
• MalfunctionMar 23, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT A PCB00 INTRAOCULAR LENS (IOL) GOT STUCK IN CARTRIDGE WITH LENS PARTIALLY INSERTED. A BACK-UP PCB00 IOL WAS IMPLANTED. IT WAS STATED THAT THE SUSPECT PRODUCT WAS DISCARDED IN THE FACILITY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9864309 ↗
• MalfunctionMar 11, 2020Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT A MODEL PCB00 INTRAOCULAR LENS (IOL) HAD SLIGHT GROOVES ON THE PERIPHERY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9816449 ↗
• InjuryFeb 18, 2020Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED IMPROPERLY LOADED. LENS WAS NOT DEPLOYED IN THE RIGHT POSITION,TRAILING HAPTIC WAS WRONGLY POSITIONED AND WAS TWISTED ON THE OPPOSITE SIDE. SURGEON LOADED THE LENS THROUGH ANOTHER CARTRIDGE. SURGEON WAS MISSING PROVISC DURING SURGERIES AND THE NURSES WERE PRELOADING THE LENSES WITH VISCOAT. NURSE EXPLAINED DOCTOR DECIDED TO ENLARGE THE WOUND FOLLOWING THE INADEQUATE DEPLOYED LENS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9718943 ↗
• MalfunctionDec 6, 2019Contamination; Contamination

  IT WAS REPORTED THAT THE DOCTOR SAW A BLUE PARTICLE IN THE EYE THAT DISAPPEARED OUT OF THE SIDE PORT. NO PATIENT INJURY OCCURRED AND NO INTERVENTIONS WERE NECESSARY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9421259 ↗
• InjuryNov 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PCB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO MISSED REFRACTIVE TARGET, WRONG LENS SIZE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES WERE REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9307814 ↗