TECNIS SIMPLICITY DCB00 (REF DCB0000130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05050474635944), received between Jan 9, 2021 and Sep 14, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762611 ↗
• MalfunctionJan 6, 2026Crack; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE INJECTOR OF PRELOADED LENS WAS TIGHT WHEN INJECTING, WHICH CAUSED THE LENS TO DISTORT AT THE TIP ON EXIT AND RESULTED IN THE TIP CRACKING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977309 ↗
• MalfunctionJun 30, 2025Wrong Label; Wrong Label

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WERE TWO INCIDENTS INVOLVING THE INCORRECT SCANNING OF INTRAOCULAR LENS (IOL) IMPLANTS. ON (B)(6) 2025, IT WAS NOTED THAT THE SERIAL NUMBERS FOR THE LENSES WERE CORRECT; HOWEVER, THE SCANNED INFORMATION INDICATED DIFFERENT POWERS THAN WHAT WAS ACTUALLY USED. SPECIFICALLY, A 13.0D LENS WAS SCANNED AS A 21.5D LENS, AND AN 11.5D LENS WAS ALSO INCORRECTLY LOGGED. THIS DISCREPANCY WAS NOT CAUGHT BY THE CIRCULATING PRACTITIONER OR THE SURGEON, LEADING TO POTENTIAL ISSUES WITH PATIENT RECORDS AND FUTURE PROCEDURES. FORTUNATELY, THE CORRECT LENSES WERE IMPLANTED IN BOTH CASES, AND NO PATIENTS WERE HARMED. THE STAFF HAS BEEN ALERTED TO BE MORE VIGILANT DURING THE SCANNING PROCESS TO PREVENT SIMILAR OCCURRENCES IN THE FUTURE. NO FURTHER INFORMATION WAS PROVIDED. A TOTAL OF TWO CASES WERE REPORTED. THE SECOND CASE HAS BEEN CAPTURED IN A SEPARATE FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22366043 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL LENS WAS EXPLANTED BECAUSE THE PATIENT EXPERIENCED VISUAL DISTURBANCES AND A REFRACTIVE SURPRISE. THE LENS WAS IMPLANTED ON (B)(6), 2024, AND WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY WHERE ANOTHER LENS OF THE SAME MODEL BUT WITH A LOWER DIOPTER FROM JOHNSON & JOHNSON WAS IMPLANTED. THERE WERE NO INJURIES OR ADDITIONAL INTERVENTIONS. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 21915059 ↗
• MalfunctionNov 26, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IN WAS REPORTED THAT A MONOFOCAL PRELOADED INTRAOCULAR LENS (IOL) DURING IMPLANTATION/APPLICATION, THE IOL WAS FULLY INSERTED BUT UNFOLDED ABNORMALLY IN THE PATIENT'S RIGHT EYE. IT WAS THEN REMOVED AND ANOTHER IOL WAS CALLED FOR AND INSERTED DURING THE SAME PROCEDURE. THERE WAS NO STUCK IN CARTRIDGE. THERE WAS NO SURGICAL OR MEDICAL INTERVENTIONS REQUIRED (EXAMPLE INCISION ENLARGEMENT, VITRECTOMY). THE PATIENT FULLY RECOVERED. THE SUSPECT PRODUCT WILL NOT BE RETURNED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20778218 ↗
• MalfunctionSep 9, 2024Break; Break

  IT IS REPORTED THAT THE MONOFOCAL LENS HAD HAPTIC BREAK. NO PATIENT HARM OCCURRED. THE CASE WAS COMPLETED WITH THE SAME MODEL AND DIOPTER LENS. THERE WAS NO PATIENT CONTACT. NO COMPLICATION INTRA-OP AND POST-OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20177173 ↗
• MalfunctionApr 12, 2024Contamination; Contamination

  IT WAS REPORTED THAT A DOCTOR IDENTIFIED SOME UNKNOWN MATERIAL ON A MONOFOCAL INTRAOCULAR LENS (IOL) THAT SHE HAD JUST IMPLANTED. THE DOCTOR INDICATED THAT SHE WAS ABLE TO REMOVE THE PARTICLES FROM THE IOL AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19101462 ↗
• InjuryMar 26, 2024Break; Break

  IT WAS REPORTED THAT UPON INSERTION OF THE PRELOADED INTRAOCULAR LENS (IOL) INTO THE PATIENT'S LEFT EYE, THE SURGEON NOTICED THAT THERE WAS A ¿CHUNK¿ MISSING OUT OF THE LENS. BACKUP LENS WAS THEN PULLED AND DEFECTIVE LENS WAS CUT OUT WITH LENS CUTTER. BACK UP LENS OF THE SAME MODEL AND SAME DIOPTER WAS IMPLANTED WITHOUT COMPLICATIONS. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. BSS WAS USED AT ROOM TEMPERATURE- OR TEMP KEPT BETWEEN 68-72 DEGREES FAHRENHEIT. BSS WAS ONLY INSERTED AT CARTRIDGE CANOPY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18982131 ↗
• MalfunctionJan 31, 2023Crack; Inaccurate Delivery; Mechanical Jam; Crack; Inaccurate Delivery; Mechanical Jam

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED IN THE LEFT EYE AND THEN REMOVED DUE TO THE LENS STUCK IN THE CARTRIDGE AND TIP WAS CRACKED/DEFORMED. THE CARTRIDGE AND LENS MADE CONTACT WITH THE PATIENT'S EYE. THE LENS IS STILL IN THE CARTRIDGE BUT THE CARTRIDGE SPLIT. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16275381 ↗
• MalfunctionDec 6, 2022Break; Break

  IT WAS REPORTED THAT AFTER INSERTING THE INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S OPERATIVE EYE, THE SURGEON NOTICED THE IOL WAS CRACKED. HE¿S BEEN DOING IMPLANTS FOR OVER 20 YEARS AND HE¿S NEVER SEEN A SIMILAR CRACK. THE CRACK WAS AT THE CENTER AND EXPANDED LIKE A STAR OUTWARDS EXTENDING IN MANY DIRECTIONS. THE SURGEON HAS A NEW TECHNICIAN, BUT DOES NOT THINK IT¿S TECHNICIAN ERROR. THE LENS HAD TO BE CUT OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP OF THE SAME MODEL AND DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY OR SUTURES. THE PATIENT IS DOING WELL POST-OPERATIVELY (OP). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15929329 ↗
• MalfunctionOct 25, 2022Material Opacification; Material Opacification

  THE PRE-LOADED DCB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DOCTOR REPORTS A HAZY DCB00; THE HAZE IS IN THE LENS AND NOT POSTERIOR CAPSULE OPACIFICATION (PCO) OR ANYTHING ELSE. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THERE IS NO PLANNED INTERVENTIONS CURRENTLY, EXCEPT OBSERVATION; THE PATIENT IS ASYMPTOMATIC. THE DOCTOR WILL CONSIDER AN IOL EXCHANGE IF IT WORSENS AND AFFECTS THE PATIENT¿S VISION; CURRENTLY PATIENT VISION IS 20/20 WITHOUT GLASSES. THERE IS NO PATIENT INJURY. THE PATIENT IS DOING WELL AFTER HIS PRIMARY SURGERY. THE DCB00 IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED IN THE PATIENT¿S EYE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15671390 ↗
• MalfunctionOct 27, 2021Break; Material Too Rigid or Stiff; Break; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS(IOL) DEVICE WAS DIFFICULT TO PUSH THROUGH WHILE SETTING-UP THE UNIT. ACCOUNT PROVIDED THAT IT WAS STIFF AND A LITTLE PRESSURE HAD TO BE APPLIED TO THE DEVICE THAT WAS FILLED WITH BALANCED SALINE SOLUTION (BSS) AND TOPPED-OFF WITH PROTECTALON 1.4% VISCOELASTIC SOLUTION. ADVANCING THE DEVICE DURING THE INSERTION STEP WAS INITIALLY LESS STIFF THAN THE PREPARATION; HOWEVER, IT BECAME STIFFER TOWARDS THE END RESULTING IN THE LENS BEING SLIGHTLY CRUMPLED AND TURNED A QUARTER TURN AS WELL AS LEAVING PLUNGER MARKS (2 TOOTH MARKS) ON THE OPTIC. THE LENS REMAINS IMPLANTED. NO INTERVENTION HAS BEEN PLANNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708746 ↗
• MalfunctionJul 9, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS PLACED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE) AND REMOVED DURING THE SAME PROCEDURE DUE TO DETACHED HAPTIC THAT BROKE OFF INTO TWO (02) PIECES. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS WITH THE SAME MODEL AND DIOPTER SIZE. THE IOL WAS DISCARDED AND IS NOT BEING RETURNED. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), AND NO UNPLANNED VITRECTOMY. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147389 ↗
• MalfunctionJan 9, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DOCTOR SAW SOME BLACK REMNANTS ON AN INTRAOCULAR LENS (IOL) UPON IMPLANTATION. ADDITIONAL INFORMATION FROM FOLLOW-UP RESPONSE STATES SURGEON HAS PRESERVED ON A CARD A PIECE OF THE FIBER, DOESN'T KNOW IF IT IS VISIBLE IF THE TAPE IS PEELED OFF. AT THE TIME OF SURGERY IT WAS REFRACTILE, LINEAR AT MOST 0.1MM IN DIAMETER AND ABOUT 2MM LONG. THE IOL WAS IMPLANTED AFTER UNCOMPLICATED SURGERY AND UNCOMPLICATED DELIVERY OF THE IOL INTO THE ANTERIOR CHAMBER. THERE WERE MULTIPLE FIBERS OR SPICULES NOTED AFTER THE IMPLANTATION INTO THE ANTERIOR CHAMBER. ALL WERE IRRIGATED AND ASPIRATED FROM THE EYE. THEY WERE VERY UNIFORM IN SIZE SHAPE AND COLOR. THE IOL WAS ALLOWED TO REMAIN IN THE EYE AND WAS PLACED INTO THE CAPSULAR BAG. PATIENT WAS REFERRAL PATIENT AND NOT FEEDBACK HAS BEEN RECEIVED ON HOW THE PATIENT DOING POST-OP. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11144180 ↗