TECNIS SIMPLICITY DCB00 (REF DCB0000205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 05050474636095), received between Oct 31, 2020 and Aug 12, 2026 — classified as 11 injuries, 82 malfunctions.

The most frequently reported specific device problem is “Break” (36 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 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Crack; Operating System Becomes Nonfunctional; Ejection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50227559 ↗
• InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED REGARDING THE JOHNSON (JNJ) INTRAOCULAR LENS (IOL). AFTER THE IOL WAS INSERTED INTO THE EYE, THE PATIENT NEEDED A VITRECTOMY DUE TO A CAPSULE TEAR. THE DOCTOR REMOVED THE LENS AND IMPLANTED A BAUSCH AND LOMB IOL. THERE WAS NO PATIENT INJURY. THE CUSTOMER EXPLAINED THAT THERE WAS NO PROBLEM WITH THE JNJ IOL, THE ISSUE OCCURRED DUE TO PATIENT ANATOMY HOWEVER THE DETAILS OF THE ANATOMY WERE NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 25626655 ↗
• MalfunctionApr 23, 2026Break; Ejection Problem

  IT WAS REPORTED THAT A SINGLE-PIECE, PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IDENTIFIED AS DEFECTIVE DURING THE SURGICAL PROCEDURE. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24975142 ↗
• MalfunctionMar 30, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED DURING THE SURGERY, AFTER THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE EYE, THE HAPTIC DID NOT OPEN. AFTER PROLONGED ADJUSTMENT, THE HAPTIC EVENTUALLY UNFOLDED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY ADVERSE IMPACT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24722946 ↗
• MalfunctionDec 30, 2025Break; Crack; Failure to Advance; Break; Crack; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS STUCK IN THE CHAMBER AND FAILED TO ADVANCE. BOTH THE DEVICE TIP AND THE LENS WERE BROKEN. THE ISSUE WAS OBSERVED PRIOR TO ANY CONTACT WITH THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACKUP LENS. NO PATIENT INJURY OCCURRED, AND NO UNPLANNED INTERVENTIONS OR SUTURES WERE REQUIRED. IT WAS REPORTED THAT THE DEVICE CONTRIBUTED TO THE EVENT. THE PATIENT IS DOING WELL WITH NO COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927510 ↗
• MalfunctionDec 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING IMPLANTATION OF A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE HAPTICS WERE FOUND ADHERED TOGETHER (¿KISSING¿ HAPTICS) DESPITE ADHERENCE TO ALL RECOMMENDED IMPLANTATION STEPS. TWO INSTRUMENTS WERE REQUIRED TO SEPARATE THE HAPTICS, AND THE SURGEON EXPRESSED CONCERN ABOUT THIS RECURRING ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SAME LENS, WHICH REMAINS IMPLANTED. THERE WAS NO UNPLANNED VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED, AND NO PATIENT INJURY SUCH AS A CAPSULAR TEAR WAS REPORTED. THE PATIENT REPORTED NO COMPLAINTS. THE ISSUE INVOLVED ONLY ONE LENS ON THAT SURGICAL DAY, ALTHOUGH SIMILAR COMPLAINTS HAVE BEEN REPORTED BY OTHER SURGEONS. THE ACCOUNT NOTES THE USE OF BALANCED SALT SOLUTION (BSS) AT ROOM TEMPERATURE INTRODUCED FROM THE HYDRATION PORT, AND THAT THE SURGEON PERFORMS AN INITIAL 1/2 TWIST AS PART OF THE IMPLANTATION TECHNIQUE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT DOCUMENTS THE EVENT REPORTED ON NOV 18, 2025. A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER REPORTED INCIDENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796826 ↗
• MalfunctionNov 26, 2025Difficult to Fold, Unfold or Collapse; Ejection Problem; Difficult to Fold, Unfold or Collapse; Ejection Problem

  IT WAS REPORTED THAT DURING INSERTION, A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS SLOW TO RELEASE FROM THE INJECTOR AND UPON RELEASE, IT REMAINED ROLLED AND APPEARED TO FLIP, RESULTING IN INCORRECT ORIENTATION WITHIN THE EYE. CONSEQUENTLY, THE LENS WAS REMOVED AND REPLACED WITH A NEW INTRAOCULAR LENS. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663139 ↗
• MalfunctionNov 26, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. IT WAS NOTED THAT IT WAS OPENED BUT NOT IMPLANTED. IT IS UNKNOWN IF THERE WAS ANY PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656234 ↗
• MalfunctionNov 25, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT VISIBLE MARKS OR SCRATCHES WERE FOUND ON THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) DURING HANDLING, PRIOR TO INSERTION. THERE WAS NO PATIENT CONTACT. DIRECTIONS FOR USE WERE FOLLOWED. NO UNPLANNED INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES WERE REQUIRED. A DELAY IN THE PROCEDURE WAS REPORTED, BUT THE LENGTH OF THE DELAY WAS NOT PROVIDED. THERE WAS NO MEDICAL ATTENTION OR MEDICATION PRESCRIBED OUTSIDE OF STANDARD CARE. IT WAS REPORTED THAT THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23652401 ↗
• InjuryNov 19, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS PLACED INTO THE PATIENT¿S EYE. THE SURGEON SPINS THE HAPTIC AND THE HAPTIC CONSEQUENTLY CUT THE BAG CAUSING IT TO COLLAPSE. A VITRECTOMY WAS PERFORMED. THE IOL WAS REPLACED WITH AN ANTERIOR LENS BY ALCON. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 23601370 ↗
• MalfunctionNov 19, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) WAS FOUND TO BE STIFF AND THE HAPTICS WERE TAKING LONGER THAN USUAL TO UNFOLD IN THE EYE. THROUGH FOLLOW UP, WE LEARNED THAT ADDITIONAL SURGICAL MANEUVERS WERE REQUIRED TO POSITION THE IOL IN THE PATIENT'S EYE. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23600400 ↗
• MalfunctionNov 4, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS CONTAMINATED. THE ASSOCIATION TO PREVENT BLINDNESS REPORTED THAT DURING THE IMPLANTATION PROCEDURE THE IOL WAS FOUND TO BE CONTAMINATED. THE IOL WAS NOT IMPLANTED AND DID NOT COME INTO CONTACT WITH THE PATIENT. TO ENSURE PATIENT SAFETY, A BACKUP IOL OF THE SAME SPECIFICATIONS SERIAL NUMBER (B)(6) WAS USED WITHOUT INCIDENT. THE CONTAMINATED LENS WAS DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23472928 ↗
• MalfunctionOct 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED BY THE CUSTOMER THAT DURING AN EYE SURGERY USING TWO PRELOADED INTRAOCULAR LENSES (IOLS), THERE WERE ISSUES WHERE THE HAPTICS WOULD NOT RELEASE. AS A RESULT, THE DOCTOR HAD TO REMOVE THE LENSES FROM THE PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED. A SEPARATE REPORT WILL BE SUBMITTED FOR THE SECOND LENS REPORTED AT THE SAME TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23331159 ↗
• MalfunctionOct 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED BY THE CUSTOMER THAT DURING AN EYE SURGERY USING TWO PRELOADED INTRAOCULAR LENSES (IOLS), THERE WERE ISSUES WHERE THE HAPTICS WOULD NOT RELEASE. AS A RESULT, THE DOCTOR HAD TO REMOVE THE LENSES FROM THE PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED. A SEPARATE REPORT WILL BE SUBMITTED FOR THE SECOND LENS REPORTED AT THE SAME TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23331157 ↗
• MalfunctionOct 16, 2025Contamination; Contamination

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), THE SURGEON AND SURGICAL TECHNICIAN OBSERVED THE PRESENCE OF TWO BLACK FIBERS IN THE PATIENT'S EYE FOLLOWING THE IMPLANTATION OF THE LENS. THE FIBERS WERE FLUSHED OUT AND REMOVED FROM THE EYE WITHOUT ISSUE, AND THE LENS REMAINS IMPLANTED. THE CARTRIDGE TIP WAS NOT DAMAGED AND THE ISSUE WAS NOT DUE TO USE ERROR. THERE WERE NO UNPLANNED SURGICAL INTERVENTIONS REQUIRED. NO MEDICATION OUTSIDE OF THE STANDARD OF CARE WAS REQUIRED. THERE WAS NO HARM OR INJURY TO THE PATIENT. THE SURGEON REPORTED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23318989 ↗
• MalfunctionSep 5, 2025Crack; Crack

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) TIP OF A CARTRIDGE WAS FOUND TO BE CRACKED. THIS CAUSED THE LENS TO EMERGE FROM THE CRACK RATHER THAN THE INTENDED TIP. THE LENS HAD NOT BEEN IMPLANTED; THE TIP OF THE CARTRIDGE WAS IN CONTACT WITH THE PATIENT'S OPERATIVE EYE. NO ADVERSE EFFECTS WAS REPORTED. THROUGH FOLLOW UP IT WAS LEARNED THAT THEY THERE WAS NO PATIENT INJURY, AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE SURGERY WAS COMPLETED USING A BACK LENS AND THERE WERE NO ISSUES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22987141 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED BY A CUSTOMER THAT THE LENS HAD BROKEN HAPTICS. REPORTEDLY CUSTOMERS DISCARDED THE LENS. THERE WAS NO PATIENT HARM OR ADVERSE EVENTS ASSOCIATED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909033 ↗
• MalfunctionAug 13, 2025Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANTATION PROCEDURE, THE INTRAOCULAR LENS WAS FULLY INSERTED INTO THE PATIENT'S EYE. HOWEVER, A CRACK WAS FOUND IN THE MIDDLE OF THE LENS. THE AFFECTED LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER DURING THE SAME SURGICAL SESSION. THE PATIENT REQUIRED AN UNPLANNED SUTURE. THE PATIENT FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798423 ↗
• MalfunctionAug 8, 2025Break; Ejection Problem; Break; Ejection Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A PIECE OF LENS LEFT IN THE INSERTER DURING USE, WHICH REQUIRED REMOVAL FROM THE PATIENT¿S OPERATIVE EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22763119 ↗
• MalfunctionAug 4, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD NO HAPTIC. THE SURGEON IMPLANTED THE LENS AND TOOK IT OUT AND THEN REPLACED IT WITH NEW ONE. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE AFTER THE LENS WAS INSERTED IN THE PATIENT'S RIGHT EYE, IT WAS THEN NOTICED THAT A HAPTIC WAS MISSING. THE LENS HAD TO BE CUT OUT AND ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS A FIVE (5) MINUTE DELAY. THE PATIENT STATUS WAS REPORTED AS UNKNOWN. IT WAS UNKNOWN IF INCISION ENLARGEMENT WAS REQUIRED, HOWEVER, THERE WERE NO SUTURES AND NO VITRECTOMY PERFORMED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709916 ↗
• MalfunctionJul 18, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD BEEN BROKEN AND DISCARDED. THERE WAS RESISTANCE WHEN INJECTING THE LENS. IT WAS REPORTED THAT THERE WAS NO PATIENT CONTACT WITH THE DEVICE. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22546075 ↗
• MalfunctionJul 16, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED, IT WAS OPENED AND NOT USED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22524421 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE AS THE LENS WAS OPENED, INSERTED INTO THE EYE AND FOUND A HUGE PIECE OF THE LENS WAS MISSING. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22333271 ↗
• MalfunctionJun 16, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE SURGEON ENCOUNTERED DIFFICULTY WITH THE PRELOADED MONOFOCAL INTRAOCULAR LENS FEELING STUCK DURING THE FINAL TURNS OF THE LENS CARTRIDGE. UPON RELEASING AND OPENING THE LENS INSIDE THE PATIENT'S EYE, DAMAGE TO THE LENS WAS OBSERVED. THE SURGEON OPTED TO LEAVE THE DAMAGED LENS IN PLACE TEMPORARILY, NOTING THAT THE PATIENT MIGHT NOT EXHIBIT SYMPTOMS RELATED TO THE DAMAGE. ADDITIONALLY, THE SURGEON REMARKED THAT THE ISSUE OF THE MODEL DCB00 LENS GETTING STUCK HAS BECOME A RECURRENT PROBLEM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22215560 ↗
• InjuryJun 12, 2025Use of Device Problem; Mechanical Jam; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED THAT THE PATIENT HAD A THREE-YEAR DECLINE IN VISION IN BOTH EYES AND AGGRAVATED VISION FOR ONE YEAR. HE UNDERWENT PHACOEMULSIFICATION AND INTRAOCULAR LENS IMPLANTATION FOR THE LEFT EYE AND DURING IMPLANTATION OF THE INTRAOCULAR LENS, IT WAS FOUND THAT THE INTRAOCULAR LENS WAS STUCK IN THE INJECTOR AND COULD NOT BE PUSHED OUT. THE INTRAOCULAR LENS WAS DAMAGED AND COULD NOT BE IMPLANTED. THE OPERATION WAS STOPPED. THE INTRAOCULAR LENS WAS THEN REIMPLANTED WHERE THE PATIENT HAD TO UNDERGO A SECOND OPERATION AND MULTIPLE ANESTHESIA, WHICH CAUSED SECONDARY DAMAGE AND INCREASED THE PATIENT'S HOSPITALIZATION TIME. THERE WAS NO OTHER DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193945 ↗