TECNIS IOL PCB00 (REF PCB0000120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474558106), received between Oct 25, 2016 and Dec 18, 2023 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (3 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jun 21, 2018Terminated

   Expired intraocular lenses were distributed.

   Z-0464-2019 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A DETACHED HAPTIC. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352503 ↗
• MalfunctionJan 14, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE LENS OPTIC WAS DAMAGED, SCRATCHED AND THE INTRAOCULAR LENS (IOL) HAD TO BE REMOVED DURING THE SAME PROCEDURE. THE ISSUE WAS FIRST IDENTIFIED DURING APPLICATION / IMPLANTATION. NO MEDICAL INTERVENTIONS WERE MENTIONED. IT WAS INDICATED THAT THE LENS WAS DISCARDED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13256897 ↗
• MalfunctionOct 24, 2021Break; Mechanical Jam; Break; Mechanical Jam

  CUSTOMER REPORTED LENS DAMAGED AND STUCK IN CARTRIDGE WITH A MODEL PCB00 TECNIS ITEC PRELOADED DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12686766 ↗
• InjuryJun 17, 2020Failure to Eject; Failure to Eject

  WHILE INSERTING THE INTRAOCULAR LENS (IOL) IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) IT WAS REPORTED THE PLUNGER DID NOT FEED THE LENS OUT, THE LENS WAS STUCK IN THE PRE-LOADED CARTRIDGE, AND THERE WAS PATIENT CONTACT WITH THE PRODUCT. THE INCISION WAS ENLARGED AND THE LENS WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10165653 ↗
• InjuryJun 5, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED PCB00 12.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2018. THE LENS WAS EXPLANTED (B)(6) 2019 DUE TO LENS DISLOCATION. IT WAS NOTED AN INCISION WAS MADE BUT NOT INDICATED AS ENLARGED. IT WAS REPORTED OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE AND THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8672803 ↗
• MalfunctionSep 18, 2018Contamination; Contamination

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, IT WAS NOTED TO HAVE AN UNIDENTIFIABLE FOREIGN OBJECT ATTACHED TO THE UNDERSIDE OF THE LENS. THE FOREIGN OBJECT WAS REMOVED AND RETAINED. THERE WAS NO INJURY TO PATIENT. THE PATIENT IS DOING FINE POSTOP. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7887881 ↗
• InjuryApr 28, 2018Premature Activation; Device Operates Differently Than Expected; Premature Activation; Device Operates Differently Than Expected

  IT WAS REPORTED THAT WHEN THE SURGEON ATTEMPTED TO INJECT THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, THE LENS WOULD NOT COME OUT OF THE CARTRIDGE. THE SURGEON CONCLUDED THAT THE PUSH ROD WAS NOT ENGAGED TO THE SECOND STEP AND PUSHED AGAIN. AFTER THIS, THE LENS SHOT OUT, PERFORATED THE CAPSULE AND DISAPPEARED INTO THE POSTERIOR SEGMENT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENS WAS IMPLANTED IN THE SULCUS AFTER RETRIEVING IT FROM THE BACK OF THE EYE. REPORTEDLY, THE LENS REMAINS IMPLANTED. THE INCISION WAS ENLARGED, A VITRECTOMY WAS PERFORMED AND SUTURES WERE USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 7471354 ↗
• MalfunctionJul 11, 2017Difficult or Delayed Positioning; Positioning Failure; Difficult or Delayed Positioning; Positioning Failure

  IT WAS REPORTED THAT DURING IMPLANTATION, AN INTRAOCULAR LENS (IOL) WOULD NOT ADVANCE OUT OF THE CARTRIDGE. REPORTEDLY, THE TIP OF CARTRIDGE TOUCHED THE PATIENT'S EYE AND THE EDGE OF THE LENS WAS IN THE EYE. THE INCISION WAS NOT ENLARGED TO REMOVE THE LENS, NO SUTURES WERE USED AND NO VITRECTOMY WAS PERFORMED. ANOTHER LENS WITH THE SAME DIOPTER WAS IMPLANTED WITHOUT DIFFICULTIES. THE PATIENT STATUS WAS REPORTED AS STABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6704500 ↗
• MalfunctionNov 17, 2016Difficult or Delayed Positioning; Positioning Failure; Device Operates Differently Than Expected; Difficult or Delayed Positioning; Positioning Failure; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A PRELOADED DELIVERY SYSTEM, MODEL PCB00, WAS PREPARED AS NORMAL AND LOADED WITH VISCOELASTICS HEALON. DURING INJECTION INTO THE EYE OF THE INTRAOCULAR LENS (IOL) THE TRAILING HAPTIC GOT STUCK INTO THE CARTRIDGE. A MCPHERSON PINCET HAD TO BE USED AND THE HAPTIC WAS RELEASED WITHOUT BREAKS OR DAMAGES. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE THERE WAS NO PATIENT INJURY OR INCISION ENLARGEMENT. THE LENS WAS IMPLANTED SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6108399 ↗
• MalfunctionOct 25, 2016Positioning Failure; Split; Positioning Failure; Split

  IT WAS REPORTED THAT THE TIP OF THE INJECTOR (CARTRIDGE) SPLIT DURING THE DEPLOYMENT OF AN INTRAOCULAR LENS (IOL). REPORTEDLY, THE LENS WAS PREPARED AS PER INSTRUCTION. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNED THE SAME ISSUE HAPPENED IN THREE OCCASIONS, DURING THE MORNING LIST, WITH A NEW SURGEON. ON THE FIRST OCCASION THE SURGEON REMOVED THE COVER AND DURING INSERTION REALISED THAT THE LENS DID NOT COME OUT OF THE TIP OF THE CARTRIDGE AND THE TIP HAD SPLIT. A NEW LENS WAS USED WITHOUT ANY PROBLEMS. THE FURTHER TWO OCCASIONS, THE SURGEON INSPECTED THE DELIVERY SYSTEM UNDER THE MICROSCOPE PRIOR TO INSERTING INTO THE PATIENT'S EYE AND FOUND THAT THE CARTRIDGE'S TIP WAS SPLIT. AGAIN NEW LENSES WERE USED. THE SURGEON BELIEVED THAT THE PLUNGER WAS PUSHING FROM THE SIDE, MISSING THE LENS, AND CAUSING THE LENS TO TWIST AROUND RATHER THAN PUSHING THE LENS STRAIGHT. REPORTEDLY IT WAS ALSO BELIEVED THAT ADEQUATE VISCOELASTIC HELON WAS USED EACH TIME. NO FURTHER INFORMATION WAS PROVIDED. THREE PRELOADED DELIVERY SYSTEM MODEL PCB00 WERE REPORTED, THEREFORE THREE MDRS WILL BE FILED. THIS MDR IS FOR SERIAL NUMBER (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6052972 ↗