TECNIS IOL PCB00 (REF PCB0000050)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474557963), received between Jul 5, 2018 and Sep 27, 2021 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2021Material Fragmentation; Mechanical Problem; Material Fragmentation; Mechanical Problem

  IT WAS REPORTED THAT THE PLUNGER OF TWO PRELOADED DEVICES DID NOT GRAB THE HAPTICS PROPERLY TO ADVANCE THE INTRAOCULAR LENS (IOL). ADDITIONALLY, HAPTIC BROKE OFF IN ONE OF THESE LENSES. THESE EVENTS OCCURRED WITH THE SAME PATIENT AND CUSTOMER CONFIRMED THAT THERE WERE NO PATIENT CONTACTS IN BOTH THESE CASES. NO OTHER INTERVENTION WAS REQUIRED. CUSTOMER PROVIDED THE TWO SERIAL NUMBERS ASSOCIATED WITH THESE EVENTS. HOWEVER, COULD NOT DIFFERENTIATE THE SERIAL NUMBERS ASSOCIATED WITH EACH OF THE EVENTS. HENCE, WE ARE REPORTING WITH AN UNKNOWN SERIAL NUMBER SUSPECT LENS. 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 12537672 ↗
• MalfunctionApr 28, 2021Mechanical Problem; Scratched Material; Mechanical Problem; Scratched Material

  IT WAS REPORTED THAT A PCB00 PLUNGER OVERRODE THE LENS AND SCRATCHED THE LENS. THERE WAS NO PATIENT CONTACT. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF SAME MODEL AND DIOPTER. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11737479 ↗
• InjuryDec 4, 2020Break; Failure to Eject; Break; Failure to Eject

  IT HAS BEEN REPORTED ISSUES WITH PCB00. CARTRIDGE WAS FILLED WITH VISCOELASTIC ACCORDING TO THE INSTRUCTION. WHEN THE SURGEON WAS ABOUT TO PUSH THE LENS FORWARD, HE FELT A RESISTANCE THAT WAS HIGHER THAN USUAL. HE THEN PRESSED A LITTLE HARDER, WITH THE LENS LEAVING THE CARTRIDGE. UPON INSPECTION, IT WAS SEEN THAT ONE OF THE LENS HAPTICS WAS PARTIALLY OFF/BROKEN. THE LENS WAS NEVER INSIDE THE PATIENT'S EYE. BECAUSE NO BACKUP LENS WAS AVAILABLE, THEY STOPPED THE SURGERY AND SENT THE PATIENT HOME. REBOOKED SURGERY IN ORDER FOR NEW LENSES TO ARRIVE AT CLINIC. NO SUTURES WERE REQUIRED, NO MEDICATIONS WERE PRESCRIBED, PATIENT FULLY RECOVERED. PATIENT WELLBEING IS INTACT AND DIDN¿T SUFFER ANY COMPLICATIONS. NEW SURGERY TOOK PLACE ON THE (B)(6) 2020, WENT GOOD. PATIENT CAME BACK FOR A CHECK UP AT (B)(6) 2020 AND IT WAS ALL GOOD. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Code Available; No Patient Involvement

  MAUDE report 10946971 ↗
• MalfunctionFeb 28, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT THE PLUNGER OF PRELOADED INTRAOCULAR LENS WENT PAST THE LENS, SO THE PARTIALLY DELIVERED LENS HAD TO BE EJECTED FROM THE EYE AGAIN. NO INTERVENTION NECESSARY, ANOTHER LENS WAS IMPLANTED AS REPLACEMENT LENS FOR THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771372 ↗
• MalfunctionJul 23, 2019Appropriate Device Problem Term/Code Not Available; Failure to Eject; Appropriate Device Problem Term/Code Not Available; Failure to Eject

  IT WAS REPORTED WHEN INSERTING INTRAOCULAR LENS (IOL) MODEL PCB0000050, WITH SERIAL NUMBER (SN) (B)(4), INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE) THE LENS WAS STUCK IN THE PRE-LOADED CARTRIDGE AND WOULD NOT FULLY DEPLOY. IT WAS REPORTED OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE, CURRENT PATIENT STATUS WAS REPORTED AS RECOVERED, AND THE LENS WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8816634 ↗
• InjuryOct 18, 2018Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF A PCB00 INTRAOCULAR LENS (IOL), THE PLUNGER OF THE INJECTOR OVERRODE THE LENS IN THE CARTRIDGE AND THE PHYSICIAN COULD NOT IMPLANT THE IOL. AS IT WAS A LOW DIOPTER IOL, THE PHYSICIAN DID NOT HAVE A BACK-UP LENS IN STOCK. THE PATIENT WAS LEFT APHAKIC AND WAS SUPPOSED TO GO BACK THE WEEK AFTER TO IMPLANT ANOTHER IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7982771 ↗
• InjuryJul 5, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE INTRAOCULAR LENS (MODEL PCB00), THERE WAS A MALFUNCTION DURING THE SCREWING OF THE PLUNGER THAT PREVENTED THE GRADUAL RELEASE OF THE IMPLANT. AS A RESULT OF THIS PROBLEM, THE SURGEON PERFORMED A RE-ENGAGEMENT MANOEUVRE OF THE PLUNGER AND OBSERVED THE SUDDEN DELIVERY OF THE LENS INTO THE PATIENT'S EYE. THE INCIDENT HAD SERIOUS CONSEQUENCES FOR THE PATIENT, INCLUDING POSTERIOR CAPSULAR RUPTURE, POSTERIOR IMPLANT DISLOCATION, VITREOUS LOSS, REMOVAL OF THE LENS, VITRECTOMY, WIDENING OF THE CORNEAL INCISION AND IMPLANTATION OF A DIFFERENT LENS INTO THE SULCUS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy; Vitreous Loss

  MAUDE report 7664303 ↗