TECNIS IOL PCB00 (REF PCB0000270)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05050474558403), received between Nov 7, 2016 and Jul 5, 2022 — classified as 6 injuries, 14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS NOT IMPLANTED BECAUSE THE HAPTIC WAS DEFECTIVE. THE ISSUE WAS NOTICED DURING HANDLING AND PRIOR TO INSERTION. THE MATERIAL IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14916854 ↗
• MalfunctionJun 7, 2022Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE DEVICE PREMATURELY DELIVERED THE LENS. CARTRIDGE TIP IN CONTACT WITH EYE. NO MORE INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14628937 ↗
• MalfunctionApr 29, 2022Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE PRELOADED INTRAOCUAR LENS (IOL) WAS DISPENSED AFTER ONE CLICK. CORRESPONDENCE FROM THE CUSTOMER INDICATED THAT THE PATIENT FULLY RECOVERED WITHOUT ANY MEDICAL INTERVENTIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14255057 ↗
• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) BROKE AND HENCE, WAS NOT IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11402536 ↗
• MalfunctionJan 8, 2021Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE INTRAOCULAR LENS (IOL) WAS DAMAGED, DEFECTIVE. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 11142301 ↗
• MalfunctionNov 18, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE PRELOADED LENS (PCB00) WAS INJECTED PREMATURELY WITHOUT BEING IN EYE PROPERLY. THERE WAS PATIENT CONTACT, AND EVENT WAS OBSERVED WHEN INSERTING INTO EYE. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10865517 ↗
• InjuryApr 13, 2020Adverse 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 PATIENT LEFT EYE. ADDITIONAL INFORMATION STATES THAT THE CUSTOMER DOES NOT KNOW ABOUT THE VISUAL ISSUES EXPERIENCED BY THE PATIENT APART FROM SLIGHT EDEMA FOLLOWING THE INITIAL IMPLANT, AND THE PATIENT IS A POST-LASIK. THERE WAS NO INJURY, MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT IS DOING GOOD. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Edema; No Code Available

  MAUDE report 9955676 ↗
• MalfunctionMar 30, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT A PCB00 27.0 DIOPTER INTRAOCULAR LENS (IOL) HAD A TRAILING HAPTIC STUCK IN THE INSERTER DURING INSERTION. THERE WAS NO PATIENT INJURY. ANOTHER LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9901348 ↗
• MalfunctionDec 13, 2019Contamination; Contamination

  IT WAS REPORTED THAT DURING A CATARACT SURGERY, AFTER A PERFECT DFU PREPARATION, THE DOCTOR OBSERVED A BLACK STRING CAME AROUND AFTER IMPLANTATION. IT HAS BEEN GONE AWAY BY IA. NO PATIENT INJURY REPORTED. SURGEON WAS NOT SURE IF PARTICLE WAS RELATED TO THE INTRAOCULAR LENS, MODEL PCB00 IMPLANTED OR THE VISCOELASTIC (OVD) MODEL HEALON PRO USED DURING PROCEDURE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. THIS REPORT IS RELATED TO THE PRODUCT, INTRAOCULAR LENS PCB00.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9467135 ↗
• MalfunctionOct 25, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE LENS POPPED OUT OF THE INSERTER UNEXPECTEDLY. THROUGH FOLLOW-UP WE LEARNED THAT THE SURGEON (B)(6) INJECTED THE HEALON AND THEN ADVANCED THE PLUNGER TO THE MARKER DURING THE PREPARATION STAGE. HE THEN MOVED TO THE EYE OF THE PATIENT AND WHEN HE WAS ABOUT TO IMPLANT THE LENS IT POPPED OUTSIDE SO ANOTHER LENS WAS USED INSTEAD WITHOUT ANY REPORTED PROBLEMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9240487 ↗
• InjurySep 13, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE INTRAOCULAR LENS, A MODEL PCB00, THE TRAILING HAPTIC WAS OBSERVED FRACTURED. LENS WAS REMOVED AND REPLACED WITH A NEW ONE. DURING LENS REMOVAL INCISION WAS ENLARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9047010 ↗
• MalfunctionApr 19, 2019Break; Contamination; Break; Contamination

  IT WAS REPORTED THAT DURING IMPLANTATION INTO THE PATIENT'S RIGHT EYE (OD), WHITE SEDIMENTS WERE OBSERVED AROUND THE INTRAOCULAR LENS (MODEL PCB00) AND SCRATCHES. REPORTEDLY, THE SURGEON PREPARED THE LENS HIMSELF WITH SUFFICIENT VISCOELASTIC IN THE INJECTOR, HE FILLED THE CHAMBER WITH VISCOELASTIC AS HE ALWAYS DOES, NO RESISTANCE WAS NOTICED AND NOTHING TO RAISE CONCERN FOR. HOWEVER, AFTER THE INJECTION INTO THE EYE, WHITISH ELEMENTS FLOATING AROUND THE LENS WERE NOTICED. IT LOOKED LIKE THE LENS HAD RUBBED AGAINST THE CARTRIDGE, IT LOOKED LIKE SHAVINGS. THE LENS REMAINS IMPLANTED. THE ACCOUNT COMMENTED THAT THE PRELOADED DELIVERY SYSTEM IS NOT AVAILABLE FOR EVALUATION. THE SAME ISSUE WAS REPORTED ON THREE (3) PCB00S. ON ONE OF THEM, THE SURGEON NOTICED QUITE A BAD SCRATCH ON THE LENS OPTIC, ALTHOUGH NOT ON THE VISUAL AXIS. THIS REPORTED IS THE SECOND OF THE THREE MDR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8530609 ↗
• MalfunctionDec 10, 2018Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS HAD A BROKEN HAPTIC. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8149348 ↗
• InjuryDec 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING INSERTION OF A PCB00 27.0 DIOPTER INTRAOCULAR LENS (IOL), THE PATIENT¿S POSTERIOR CAPSULE RUPTURED. A VITRECTOMY WAS REQUIRED. THE PCB00 LENS WAS REMOVED AND REPLACED WITH A THREE-PIECE LENS. NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 8140614 ↗
• MalfunctionOct 8, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PCB00 INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITHIN THE INITIAL PROCEDURE WHEN THE SURGEON NOTICED BOTH HAPTICS WERE SHEARED OFF UPON INSERTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7944879 ↗
• InjuryMay 23, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PATIENT IS EXPERIENCING BLURRY VISION IN LEFT EYE AND VISUAL ACUITY IS 20/60 POST IMPLANT OF A PCB00 27.0 DIOPTER INTRAOCULAR LENS(IOL). SURGEON THINKS THERE MAY BE LABELLING ERROR AND ALSO REPORTED THAT THERE IS REFRACTIVE ERROR AT -1.93. REPORTEDLY THERE IS NO PLAN TO EXPLANT THE LENS RIGHT NOW BECAUSE THE PATIENT DOESN'T WANT TO DO IT AT THIS TIME, HOWEVER SURGEON IS CONSIDERING LASIK AND ALSO NOTED THERE WERE SUTURES USED ON THE CORNEA TO CORRECT ASTIGMATISM. THE PATIENT WAS REPORTED TO BE DOING FINE WHEN DISCHARGED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7539672 ↗
• InjuryOct 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO THAT THE DOCTOR IMPLANTED A LENS IN THE WRONG PATIENT. THERE WERE NO ISSUES WITH THE QUALITY OF THE PRODUCT. THE LENS WAS INSERTED IN THE RIGHT EYE AND REMOVED DURING THE SAME PROCEDURE. THE INCISION WAS ENLARGED. A VITRECTOMY WAS NOT PERFORMED. REPORTEDLY THE LENS WAS REPLACED WITH ANOTHER PCB00. NO PATIENT SYMPTOMS. THE PATIENT¿S OUTCOME IS NORMAL. NO OTHER MEDICAL/SURGICAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 6953902 ↗
• MalfunctionApr 3, 2017Bent; Bent

  IT WAS REPORTED THAT THE CARTRIDGE TIP, OF A PRELOADED DELIVERY SYSTEM MODEL PCB00, WAS BENT. NO PATIENT INVOLVEMENT OR INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6455522 ↗
• InjuryJan 5, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PCB00 27.0 DIOPTER WAS EXPLANTED FROM A FEMALE PATIENT'S RIGHT EYE DUE TO A REFRACTIVE SURPRISE. THE PATIENT ENDED UP WITH A MYOPIC SHIFT OF -5 DIOPTER. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A 22.0 DIOPTER. INCISION ENLARGEMENT OF 2.75 WAS REQUIRED TO MAKE THE LENS EXCHANGE POSSIBLE. THE PATIENT IS CURRENTLY DOING OKAY WITH THE NEW LENS. THE EXPLANTED LENS WAS NOT AVAILABLE AS IT HAD DISCARDED. PATIENT'S VISUAL ACUITY: VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): 20/50. VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT): 20/70. VISUAL ACUITY POST-OP (POST-REPLACEMENT): 20/30.

  Patient problems: No Code Available

  MAUDE report 6227359 ↗
• MalfunctionNov 7, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), MODEL PCB00, THE SURGEON NOTICED ABOUT FIVE (5) PIECES OF BROWN DEBRIS, OF WHICH ABOUT THREE (3) WENT INTO THE PATIENT'S EYE AND WERE SUBSEQUENTLY REMOVED. THERE WERE NO PATIENT ISSUES REPORTED POST-OP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6084710 ↗