TECNIS IOL PCB00 (REF PCB0000205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 144 adverse event reports that list this exact device (DI 05050474558274), received between Aug 25, 2016 and Sep 25, 2024 — classified as 47 injuries, 97 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 144 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED DRY AND UNCOMFORTABLE EYES, FOREIGN BODY SENSATION AND EYE PAIN. THESE WERE RELIEVED WITH SYMPTOMATIC TREATMENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Discomfort; Dry Eye(s); Eye Pain; Foreign Body Sensation in Eye

  MAUDE report 20304372 ↗
• InjuryJul 2, 2024Use of Device Problem; Mechanical Jam; Ejection Problem; Use of Device Problem; Mechanical Jam; Ejection Problem

  IT WAS REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) WAS NOT EJECTING. THE SURGEON AND TECH CLAIM THAT THE LENS GOT STUCK WHEN INJECTING. THE DOCTOR USED EXTRA FORCE (MORE PRESSURE) ON PLUNGER AND LENS CAME OUT FORCEFULLY AND BROKE CAPSULE. THE SURGERY WAS FINISHED USING A NON-JOHNSON & JOHNSON LENS OF 18.5 DIOPTER. THE AFFECTED EYE WAS THE RIGHT EYE AND THERE WAS PATIENT CONTACT. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REPORTED. THE ACCOUNT NOTED IT IS UNKNOWN IF THE PROBLEM RELATED TO USE ERROR. IT IS UNKNOWN IF THE PATIENT HAD A CAPSULE TEAR AND THE PATIENT OUTCOME STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 19662280 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERSISTENT GLARE, HALOS, AND STARBURSTS WHICH WERE REPORTED AS "VERY TROUBLESOME" FOLLOWING IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. THE IOL WAS IMPLANTED ON (B)(6) 2023. THE SURGEON COMPLETED A YTTRIUM ALUMINUM GARNET (YAG) PROCEDURE IN (B)(6) 2023 TO "RULE OUT" POSTERIOR CAPSULAR OPACIFICATION (PCO). POST OPERATIVE DATA PROVIDED BY THE SURGEON INDICATED THE FOLLOWING RESULTS FOR THE RIGHT EYE: AUTOREFRACTOR PLANO / -0.5@127 WITH VISUAL ACUITY (VA) 6/5. FURTHER FOLLOW UP REVEALED THAT THE PATIENT IS STILL ABLE TO DRIVE AND THE VISUAL DISTURBANCE, WHILE BEING VERY FRUSTRATING, IS NOT PREVENTING THE PATIENT FROM COMPLETING DAILY ACTIVITIES. DURING AN EXAMINATION ON (B)(6) 2023 THE PATIENT DESCRIBED GLARE AND HALOS, BUT VA IS 6/6. AS PER THE SURGEON A PCO WOULD NOT HAVE BEEN UNUSUAL AS IT WAS A POSTERIOR SUBCAPSULAR CATARACT (PSC). WE ALSO LEARNED THAT THE YAG PROCEDURE PERFORMED MADE THE GLARE / HALO (FINE CIRCLE) / STARBURST MORE OBVIOUS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Flashers; Halo; Visual Disturbances

  MAUDE report 18938195 ↗
• MalfunctionDec 21, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THERE WERE CRACKS OBSERVED ON THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) AND THEY WERE ONLY OBSERVED IN THE OPTICAL PART OF THE IOL AFTER BEING PUSHED OUT. ONE OF THE CRACKS WAS CLOSEST TO THE CENTER OF THE OPTICAL PART. THE LENS WAS NOT REMOVED DUE TO THE PATIENT'S HIGH SENSITIVITY TO PAIN. THE PATIENT HAD MILD EDEMA BEFORE SURGERY. AFTER SURGERY, THE PATIENT'S VISION WAS 0.3. IT WAS HARD TO DETERMINE THE EXTENT OF THE CRACK'S IMPACT ON PATIENT'S VISION. BASED ON THE ADDITIONAL INFORMATION RECEIVED, EDEMA REPORTED IS CORNEAL EDEMA AND PATIENT GRADUALLY RECOVERED FROM IT BY THE TIME OF DISCHARGE. THE PAIN REPORTED IS EYE PAIN. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. PATIENT HAS MADE A FAIR POSTOPERATIVE RECOVERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; Eye Pain

  MAUDE report 18376802 ↗
• MalfunctionNov 8, 2023Break; Break

  IT WAS REPORTED THAT WHEN PRELOADED INTRAOCULAR LENS WAS BEING PREPARED DURING SURGERY, IT WAS FOUND TO BE DAMAGED AND COULD NOT BE USED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18096735 ↗
• MalfunctionMar 16, 2023Break; Break

  IT WAS REPORTED THAT THE LENS WAS FAULTY, THE HAPTIC WAS TRAPPED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16559656 ↗
• MalfunctionFeb 27, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT HAPTIC DETACHMENT WAS OBSERVED ON THE PCB00 MODEL OF INTRAOCULAR LENS (IOL). UPON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16449264 ↗
• MalfunctionFeb 27, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT HAPTIC DETACHMENT WAS OBSERVED ON THE PCB00 MODEL OF INTRAOCULAR LENS (IOL). UPON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16449236 ↗
• MalfunctionJan 12, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT SURGEON IMPLANTED THE PRELOADED INTRAOCULAR LENS (IOL) WITHOUT ANY DIFFICULTY. HOWEVER, WHEN THE HAPTICS UNFOLDED, IT WAS OBSERVED THAT THE TRAILING HAPTIC WAS MISSING. THE IOL WAS CUT AND REMOVED. THE INCISION WAS NOT ENLARGED, AND NO FURTHER TREATMENT WAS NECESSARY. THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16151845 ↗
• MalfunctionSep 7, 2022Material Opacification; Material Opacification

  IT WAS REPORTED THAT AFTER THE SURGEON IMPLANTED AN INTRAOCULAR LENS A DARK SPOT WAS FOUND ON THE OPTIC. THE SURGEON ADVISED THE PATIENT BUT HAS LEFT LENS IN THE EYE TO MONITOR THE OUTCOME. THROUGH FOLLOW UP IT WAS LEARNED THAT THE LENS IS NOT AVAILABLE AS IT REMAINS IMPLANTED. THERE ARE NO PLANS TO EXPLANT THE LENS AND NO PICTURES ARE AVAILABLE. THE PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375603 ↗
• MalfunctionAug 18, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15251389 ↗
• MalfunctionJul 28, 2022Break; Break

  IT WAS REPORTED THAT PCB00 LENS JAMMED, LENS DAMAGED AND NOT IMPLANTED NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127079 ↗
• MalfunctionMay 2, 2022Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A DEFECT IN THE MIDDLE OF THE LENS AND THAT IT WAS DIFFICULT TO PUSH IT THROUGH THE INJECTOR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14258580 ↗
• MalfunctionFeb 18, 2022Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) GOT STUCK AND THAT ONE OF THE HAPTICS WAS DEFECTED. ACCOUNT INDICATED THAT THERE WAS NO PATIENT IMPACT AND THAT THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13562978 ↗
• MalfunctionJan 27, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13377985 ↗
• MalfunctionNov 22, 2021Break; Break

  IT HAS BEEN REPORTED LENS DEFECTIVE. THROUGH FOLLOW-UP IT WAS CONFIRMED THAT DURING THE PREPARATION OF THE INJECTOR TO IMPLANT THE LENS, THERE HAS BEEN A PROBLEM THAT APPEARS TO HAVE DAMAGED THE LENS; IT HAS BEEN CONFIRMED THAT THERE HAS NOT BEEN PATIENT'S CONTACT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857551 ↗
• MalfunctionSep 30, 2021Crack; Crack

  IT WAS REPORTED BY THE DOCTOR ,"SHOOTER BROKEN IN FRONT." THROUGH FOLLOW UP IT WAS CONFIRMED THAT THE CARTRIDGE TIP BROKE. THE CARTRIDGE TIP MADE CONTACT WITH THE EYE. THE OPERATION WAS COMPLETED WITH A DIFFERENT IOL (INTRAOCULAR LENS) AND THAT THERE WAS A NORMAL OPERATION AFTERWARD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558958 ↗
• MalfunctionSep 28, 2021Inaccurate Delivery; Operating System Becomes Nonfunctional; Inaccurate Delivery; Operating System Becomes Nonfunctional

  ON (B)(6) 2021, ACCORDING TO THE DOCTOR, THERE WAS AN IMPLANTATION PROBLEM. THE INJECTOR WAS FILLED WITH HEALON AND THEN PUSHED TO THE FIRST MARK SHORTLY BEFORE THE IMPLANTATION ACCORDING TO NORMAL PROCEDURE. HOWEVER, THE PLUNGER DID NOT ENGAGE AND THE THREAD DID NOT GRIP. THEREFORE, THE LENS SLID OUT OF THE INJECTOR IN AN UNCONTROLLED FASHION. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544728 ↗
• MalfunctionAug 19, 2021Inaccurate Delivery; Inaccurate Delivery

  CUSTOMER REPORTED THAT WHILE PERFORMING A CATARACT SURGERY THE INTRAOCULAR LENS (IOL) MODEL PCB00 BECAME "CHOKED" IN THE INJECTOR EXIT ORIFICE DURING THE IMPLANTATION STEP MAKING IT IMPOSSIBLE TO RELEASE THE IOL INTO THE ANTERIOR CHAMBER OF THE PATIENT'S LEFT EYE. THE INJECTOR WAS REMOVED FROM THE EYE AND A NEW INTRAOCULAR LENS IMPLANTED. THERE WERE NO SURGICAL COMPLICATIONS OR HARM TO THE PATIENT. A REPLACEMENT LENS WAS IMPLANTED IN THE CAPSULAR BAG. PATIENT HAS REPORTEDLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12346141 ↗
• InjuryAug 4, 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 IMPLANTED AND EXPLANTED FROM PATIENT'S OPERATIVE EYE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 12278191 ↗
• MalfunctionJul 15, 2021Crack; Mechanical Problem; Material Too Rigid or Stiff; Crack; Mechanical Problem; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE PLUNGER OF THE PRELOADED DEVICE WAS REALLY DIFFICULT TO ADVANCE AND WHEN IT DID, IT SKIPPED THE INTRAOCULAR LENS. THERE WAS NO PATIENT CONTACT AS THE EVENT WAS OBSERVED DURING HANDLING, BUT PRIOR TO INSERTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177966 ↗
• MalfunctionJul 13, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A PCB00 MODEL INTRAOCULAR LENS(IOL) WAS FULLY INSERTED AND REMOVED DUE TO LENS NOT DISPENSING PROPERLY AND REPLACED IN THE SAME PROCEDURE WITH ANOTHER LENS OF SAME MODEL BUT DIFFERENT DIOPTER. PHYSICIAN ATTEMPTED TO MANEUVER BUT WAS UNSUCCESSFUL. NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE DONE. PATIENT WAS DOING GOOD AT THE TIME OF DISCHARGE. ADDITIONAL DETAILS RECEIVED STATES THAT ¿LENS DID NOT DISPENSE PROPERLY¿ INDICATES THAT LENS DID NOT UNFOLD AND THAT THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164321 ↗
• MalfunctionJul 13, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A PCB00 MODEL INTRAOCULAR LENS(IOL) WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE AND REMOVED DUE TO LENS NOT DISPENSING PROPERLY AND REPLACED IN THE SAME PROCEDURE WITH ANOTHER LENS OF SAME MODEL BUT DIFFERENT DIOPTER. PHYSICIAN ATTEMPTED TO MANEUVER BUT WAS UNSUCCESSFUL. NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE DONE. PATIENT WAS DOING GOOD AT THE TIME OF DISCHARGE. ADDITIONAL DETAILS RECEIVED STATES THAT ¿LENS DID NOT DISPENSE PROPERLY¿ INDICATES THAT LENS DID NOT UNFOLD AND THAT THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164315 ↗
• MalfunctionJun 4, 2021Material Fragmentation; Material Fragmentation

  THE ACCOUNT REPORTED ONE OF THE HAPTICS WAS MISSING ON A PRE-LOADED INTRAOCULAR LENS (IOL). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11943547 ↗
• MalfunctionJun 4, 2021Break; Break

  IT WAS REPORTED THAT THE SURGEON HAD TO REMOVE THIS INTRAOCULAR LENS (IOL) AS IT HAD A SCRATCH OF THE SIDE OF THE LENS AND THE OPTIC WAS FAULTY. THEY HAD TO USE A BACKUP IOL. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942640 ↗