TECNIS IOL PCB00 (REF PCB0000130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05050474558120), received between Oct 6, 2016 and Nov 1, 2023 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT TWO (2) PRELOADED MONOFOCAL INTRAOCULAR LENSES (IOL) DID NOT OPEN WITH PATIENT CONTACT. THROUGH FOLLOW UP WE LEARNED THAT WHEN THE CUSTOMER WENT TO INJECT THE LENSES, THEY WOULD NOT UNFOLD. ACCOUNT INDICATED THAT PATIENTS WERE OKAY. THROUGH FURTHER FOLLOW UP WE LEARNED THAT THE LENSES WERE INSERTED INTO THE PATIENT'S OPERATIVE EYE AND THERE WERE ADDITIONAL MANEUVERS TO POSITION THE LENSES DUE TO FAILURE TO UNFOLD. THE LENSES WERE REMOVED AND REPLACED WITHIN THE SAME PROCEDURE. NO FURTHER INTERVENTION WAS REQUIRED. NO MATERIAL IS AVAILABLE TO RETURN. NO FURTHER INFORMATION WAS PROVIDED. THIS ISSUE OCCURRED TWICE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER LENS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18052350 ↗
• MalfunctionAug 11, 2021Device Difficult to Setup or Prepare; Inaccurate Delivery; Device Difficult to Setup or Prepare; Inaccurate Delivery

  IT WAS REPORTED THAT THE CUSTOMER HAD DIFFICULTY IN ADVANCING THE PRELOADED INTRAOCULAR LENS (IOL) AND THE LENS WAS ADVANCED TOO FAR AND EJECTED. THE LENS WAS NOT INSERTED INTO PATIENT'S OPERATIVE EYE. THERE WAS NO INJURY AND NO INTERVENTION WAS PERFORMED. THE PATIENT WAS DOING FINE POST-OPERATIVELY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305714 ↗
• MalfunctionJun 1, 2021Break; Difficult to Fold, Unfold or Collapse; Break; Difficult to Fold, Unfold or Collapse

  DOCTOR REPORTED THAT WHILE INSERTING THE IOL INTO THE PATIENT¿S LEFT EYE, THE HAPTIC WAS TWISTED BUT SHE FELT COMFORTABLE TO IMPLANT THE IOL. THE DOCTOR BELIEVES THAT WHEN THE IOL IS INSERTED, THE TRAILING HAPTIC IS EITHER TWISTED OR NOT FOLDED PROPERLY. THEREFORE, WHEN THE IOL ADVANCES IT MAKES THE IRIS FLOPPY FROM THE HAPTIC DRAGGING OVER THE IRIS. THE DOCTOR IS STARTING TO SEE THIS HAPPEN OFTEN. FURTHERMORE, APPROXIMATELY ONE-MONTH POST-OP THE DOCTOR NOTICED A SMALL CHIP IN THE IOL. HOWEVER, IT DID NOT SEEM TO BOTHER THE PATIENT. THE IOL REMAINS IMPLANTED. REPORTEDLY, THE PATIENT IS DOING ¿OK¿ POST-OP. THE CUSTOMER STATED THAT NO FOLLOW-UP ON OUR PART IS NEEDED AS NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11917411 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD BILATERAL IMPLANTS WITH THE TECNIS ITEC PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). SHE CALLED ASKING IF JOHNSON AND JOHNSON KNEW WHAT THE LENSES WERE MADE OF. SHE THEN ASKED IF THE LENSES HAD BEEN RECALLED. SHE REPORTED THAT SHE IS SEEING BOUNCING LIGHTS WITH HER RIGHT EYE AND STARBURSTS IN HER LEFT EYE, EVEN STORE, AND RESTAURANT LIGHTS GIVE HER STARBURSTS. SHE HAS SPOKEN TO HER DOCTOR ABOUT THESE ISSUES, AND THEY TOLD HER TO TRY YELLOW GLASSES, AND TO KEEP HER EYES MOISTURIZED. THEY ALSO GAVE HER LUMIFY EYE DROPS, HOWEVER SHE HAS NOT TRIED IT YET BECAUSE SHE DOES NOT WANT TO PUT ANOTHER DROP IN HER EYES SINCE SHE ALREADY USES A SYSTAINE AND A GLAUCOMA DROP CALLED XALATAN ONCE IN BOTH EYES BEFORE BED. SHE STATED THAT RIGHT AWAY HER LEFT EYE FOGGED UP, AND THEY DID A CAPSULOTOMY, AND SHE CAN SEE 20/20 OUT OF IT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Flashers; Visual Disturbances

  MAUDE report 11737688 ↗
• InjuryMar 31, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT WHILE INSERTING A PCB00, 13.0 DIOPTER INTRAOCULAR LENS (IOL) INTO THE LENS INTO THE PATIENT¿S LEFT EYE A CAPSULE TEAR OCCURRED. AN ANTERIOR VITRECTOMY WAS REQUIRED, AND THE LENS WAS REMOVED AND REPLACED WITH A SULCUS LENS, HOWEVER NO INCISION ENLARGEMENT WAS REQUIRED. THROUGH FOLLOW-UP IT ADDITIONAL DETAILS WERE PROVIDED. AFTER INSERTION THE LENS WAS NOTED TO DECENTER AND THE POSTERIOR CAPSULE TEAR WAS DISCOVERED. THE LENS WAS CUT OUT AND REMOVED. THE REPLACEMENT LENS WAS A ZA9003 THAT WAS NOTED TO BE SCRATCHED AFTER INSERTION AND WAS REMOVED AND REPLACED WITH A SECOND ZA9003 LENS. ONE-WEEK POST EXCHANGE THE PATIENT WAS SEEN FOR A RETINAL DETACHMENT AND DECREASED VISION, BUT NO RETINAL SURGERIES WERE NOTED. PATIENT WAS MONITORED UNTIL STABLE.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 8467982 ↗
• MalfunctionFeb 27, 2019Break; Positioning Failure; Physical Resistance/Sticking; Break; Positioning Failure; Physical Resistance/Sticking

  IT WAS REPORTED THAT LENS MODEL, PCB00 MONOFOCAL IOL (INTRAOCULAR LENS) WAS PUSHED OUTSIDE THE LUMEN OR DELIVERY SYSTEM. THOUGH, LENS APPEARS STUCK AND DAMAGED. IT WAS ALSO NOTED THAT THIS ISSUE WAS NOTICED BY THE DOCTOR WHILE IMPLANTATION. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8372826 ↗
• InjuryMay 24, 2018Crack; Difficult to Fold, Unfold or Collapse; Crack; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT CARTRIDGE CRACKED WHILE INSERTING PCB00 INTRAOCULAR LENS INTO THE PATIENT'S EYE. IT WAS NOTED THAT THERE WAS ALSO FOLDING/UNFOLDING ISSUE WITH THE LEAD HAPTIC. THEREFORE, IOL HAS TO BE REMOVED FROM THE PATIENT'S EYE AND REPLACED WITH OTHER PCB00 LENS. THERE WAS PATIENT CONTACT, BUT NO PATIENT INJURY REPORTED, NO INCISION ENLARGEMENT AND NO SUTURE REQUIRED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7542184 ↗
• InjuryMar 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PCB00 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE LENS MADE THE PATIENT TOO NEAR SIGHTED. THERE WAS NO INCISION ENLARGEMENT, BUT A SUTURE WAS USED. THE REPLACEMENT LENS USED WAS A DIFFERENT MODEL. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7343173 ↗
• MalfunctionNov 22, 2017Crack; Crack

  IT WAS REPORTED THAT A PCB00 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS NOTICED CRACKED WHEN REMOVING FROM PACKAGING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7054913 ↗
• MalfunctionJun 30, 2017Split; Split

  IT WAS INITIALLY REPORTED THAT THE CARTRIDGE SPLIT DURING HANDLING BUT PRIOR TO INSERTION. DURING FOLLOW UP, THE CUSTOMER CONFIRMED THAT AS THE TECHNICIAN WAS TRYING TO MOVE THE INTRAOCULAR LENS (IOL) OUT, THE CARTRIDGE SPLIT AT THE TIP. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6682856 ↗
• MalfunctionMay 29, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A PHYSICAL DEFECT/A HUGE GOUGE IN THE CENTER OF THE POSTERIOR SIDE OF THE OPTIC. REPORTEDLY, THE LENS WAS IMPLANTED AND REMOVED. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6596402 ↗
• MalfunctionFeb 14, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT DURING IMPLANTATION OF A PCB000 13.0 DIOPTER INTRAOCULAR LENS (IOL), THE LENS WOULD NOT ADVANCE. THROUGH FOLLOW-UP IT WAS CONFIRMED THAT THE LENS GOT STUCK IN THE CARTRIDGE AND WOULD NOT ADVANCE. THE ACTUAL LENS TOUCHED THE PATIENT EYE, HOWEVER THERE WAS NO PATIENT INJURY REPORTED. THE LENS WAS REPLACED WITH A BACKUP LENS WITHOUT ANY OTHER ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6330829 ↗
• MalfunctionDec 30, 2016Torn Material; Torn Material

  IT WAS REPORTED THAT AFTER INSERTION OF A PCB00 INTRAOCULAR LENS (IOL) THE SURGEON OBSERVED LARGE GASHES ON THE IOL. THE IOL WAS REMOVED AND A NEW LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED. THERE WAS NO INJURY TO THE PATIENT AND THE LENS WAS NOT SAVED AFTER BEING REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6216732 ↗
• InjuryDec 8, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING INSERTION OF A PCB00 INTRAOCULAR LENS (IOL) IN A MALE PATIENT'S LEFT EYE, THE LENS GOT STUCK IN CARTRIDGE. THERE WAS PATIENT CONTACT, HOWEVER THE LENS WAS NOT INSERTED, BUT AN INCISION ENLARGEMENT WAS INDICATED. THERE WAS NO PATIENT INJURY, NO VITRECTOMY AND NO INJURY POST-OP.

  Patient problems: No Code Available

  MAUDE report 6153754 ↗
• MalfunctionOct 6, 2016Wrinkled; Wrinkled

  DURING SURGERY AND AFTER PERFECTLY FOLLOWING THE STEPS FOR THE CORRECT IMPLANTATION OF THE LENS, THE LAST STEP WAS PERFORMED AND THE LENS DID NOT COME OUT, INSTEAD, IT REMAINS CREASED IN ONE OF THE CARTRIDGE SIDES. NO PATIENT INVOLVEMENT/INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6005467 ↗