TECNIS IOL DFR00V (REF DFR00VU195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 05050474750661), received between Oct 14, 2021 and Mar 1, 2025 — classified as 18 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2025Break; Crack; Mechanical Jam; Break; Crack; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) GOT STUCK IN THE CARTRIDGE. THE SURGEON ATTEMPTED TO INSERT THE IOL. THE SURGEON FELT RESISTANCE WHEN TURNING THE INSERTER AS THE IMPLANTATION WAS ATTEMPTED. THE SURGEON THOUGHT IF THE DEVICE WAS TURNED FURTHER THE LENS WOULD CRACK. THE CARTRIDGE TIP MAY HAVE BEEN DAMAGED. THE IOL WAS SUBSEQUENTLY INSERTED, THEN REMOVED AND REPLACED DURING THE SAME PROCEDURE. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT OR SUTURES. THE PATIENT¿S STATUS WAS REPORTED AS ¿UNKNOWN¿. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21499543 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. THE PATIENT IS EXPERIENCING FLOATERS, RAINBOWS, HALOS AND STARBURST AROUND LIGHTS AND CHROME COLORED OBJECTS. PATIENT WAS DIAGNOSED WITH POSTERIOR CAPSULE OPACIFICATION AND HAD A YAG (YTTRIUM-ALUMINUM GARNET LASER TREATMENT) AND VITRECTOMY PROCEDURE. THE IMPLANTING DOCTOR INFORMED HER THAT SHE HAD ABNORMAL INFLAMMATION IN HER EYE AND REFERRED HER TO AN EXPERT. THE SECOND DOCTOR STATED THERE WAS NOTHING WRONG WITH HER EYES AND THAT IT WAS NORMAL INFLAMMATION. THE SYMPTOMS WERE NOTICED ¿RIGHT AFTER THE PROCEDURE¿ BUT THE EXACT DATE IS UNKNOWN. AFTER THE IMPLANTS SHE COULD NO LONGER DRIVE AT NIGHT. THE PATIENT REPORTED THAT THE ONLY REASON SHE DID THE IMPLANTS WAS FOR BETTER NIGHT VISION BUT IT¿S GOTTEN SIGNIFICANTLY WORSE SINCE THE IMPLANTS. SHE LIVES IN A PART OF THE COUNTRY WHERE IT GETS DARK VERY EARLY AND SHE CANNOT GO ANYWHERE UNLESS SHE IS DRIVEN. THE DOCTOR SAID HER BRAIN NEEDS TIME TO ADJUST BUT IT¿S BEEN TWO YEARS. THE PATIENT REVIEWED EXPLANTING THE IOLS WITH HER DOCTOR. REPORTEDLY, THE DOCTOR SAID, ¿IN 24 YEARS OF PRACTICE HE HAS NEVER SEEN A LENS REPLACEMENT

  Patient problems: Flashers; Halo; Posterior Capsule Opacification; Vitreous Floaters

  MAUDE report 20720783 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S EYE AS THE PATIENT WAS BEING NOT HAPPY WITH HER VISION. THE LENS WAS REPLACED WITH ZXR00 LENS IN A SECONDARY PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 20147932 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED TECNIS SYNERGY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE (OD) DUE TO INTOLERABLE VISUAL SIDE EFFECTS OF THE IOL IMPLANT. IT WAS LEARNED THAT THE VISUAL SYMPTOMS WERE BLURRY VISION AND HALOS. THE LENS WAS REPLACED WITH A MONOFOCAL IOL OF THE SAME DIOPTER POWER SIZE AS THE ORIGINAL IOL. PATIENT OUTCOME FROM THE REPLACEMENT IOL NOTED AS PATIENT MUCH HAPPIER. ADDITIONALLY, IT WAS NOTED THAT THE LEFT EYE (OS) WAS ALSO IMPLANTED WITH THE SAME MODEL AND DIOPTER SIZE AS THE ONE IMPLANTED IN THE RIGHT EYE. IT WAS LEARNED THAT THE VISUAL SYMPTOMS FOR OS WERE ALSO BLURRY VISION AND HALOS WHICH THE PATIENT IS STILL EXPERIENCING AS THE IOL REMAINS IMPLANTED IN THE OS. IT WAS NOTED THAT THE EXTENT OF VISUAL SYMPTOMS MADE THE PATIENT UNABLE TO READ AND HAVE ISSUES WITH DISTANCE VISION. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE RIGHT EYE (OD). A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE (OS).

  Patient problems: Blurred Vision; Halo

  MAUDE report 19630186 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED TECNIS SYNERGY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE (OD) DUE TO INTOLERABLE VISUAL SIDE EFFECTS OF THE IOL IMPLANT. IT WAS LEARNED THAT THE VISUAL SYMPTOMS WERE BLURRY VISION AND HALOS. THE LENS WAS REPLACED WITH A MONOFOCAL IOL OF THE SAME DIOPTER POWER SIZE AS THE ORIGINAL IOL. PATIENT OUTCOME FROM THE REPLACEMENT IOL NOTED AS PATIENT MUCH HAPPIER. ADDITIONALLY, IT WAS NOTED THAT THE LEFT EYE (OS) WAS ALSO IMPLANTED WITH THE SAME MODEL AND DIOPTER SIZE AS THE ONE IMPLANTED IN THE RIGHT EYE. IT WAS LEARNED THAT THE VISUAL SYMPTOMS FOR OS WERE ALSO BLURRY VISION AND HALOS WHICH THE PATIENT IS STILL EXPERIENCING AS THE IOL REMAINS IMPLANTED IN THE OS. IT WAS NOTED THAT THE EXTENT OF VISUAL SYMPTOMS MADE THE PATIENT UNABLE TO READ AND HAVE ISSUES WITH DISTANCE VISION. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE LEFT EYE (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE (OD).

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 19630178 ↗
• InjuryMar 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO "MECHANICAL FAILURE". THERE WAS NO PATIENT INJURY. AN INCISION ENLARGEMENT WAS REQUIRED. NO SUTURE OR VITRECTOMY WAS REQUIRED. AMVISC VISCOELASTIC WAS USED. THROUGH FOLLOW-UP, IT WAS CLARIFIED THAT "MECHANICAL FAILURE" MEANT THAT THE PATIENT REPORTED WORSENING CONSTANT HAZY VISION AT DISTANCE AND NEAR, ESPECIALLY WHEN DRIVING AND READING. THE PATIENT DID NOT LIKE THE QUALITY OF VISION WITH THE MULTIFOCAL IMPLANT. ANOTHER JOHNSON AND JOHNSON LENS WAS IMPLANTED AS REPLACEMENT (ZCB00, +19.0 DIOPTER). THE PATIENT'S PRE-OPERATIVE UNCORRECTED VISUAL ACUITY (VA) WAS 20/25-1, BEST CORRECTED VA WAS 20/20. THE PATIENT'S POST-OPERATIVE (POST-INITIAL IMPLANT) UNCORRECTED VA WAS 20/20-2, BEST CORRECTED VA 20/20. THE TARGETED POST-OPERATIVE REFRACTION (FOR INITIAL IMPLANT) WAS EMMETROPIA. THERE WAS NO CALCULATION ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 19008915 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT COMPLAINED OF GLARES AND BLURRY VISION. THE EXPLANTED LENS WAS REPLACED WITH A DIB00 19.5D. THERE WAS NO PATIENT INJURY. THERE IS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 18862286 ↗
• InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS SIMPLICITY PRELOADED INTRAOCULAR LENS (IOL) NEEDS TO BE EXPLANTED AND HAVE IT REPLACED. ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT HAD DYSPHOTOPSIAS. PATIENT IS STILL EXPERIENCING DYSPHOTOPSIAS AND WANTING FOR LENS TO BE EXPLANTED AND REPLACED WITH DXR00V. IT WAS STATED THAT THE LENS WILL BE EXPLANTED IN NEXT 30 DAYS. FURTHER INFORMATION RECEIVED STATED THAT THE VISUAL ACUITY PRIOR TO THE IMPLANTATION OF THE ORIGINAL LENS WAS 20/80 AND VISUAL ACUITY AFTER THE IMPLANTATION OF THE ORIGINAL LENS WAS 20/40-20/30. PATIENT HAD TROUBLE WITH GOLFING AND OUTDOOR ACTIVITY DUE TO GLARE. IOL REPOSITIONING WAS DONE WHICH ONLY WORKED FOR ABOUT A WEEK. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 17988735 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE DUE TO VISION DISTURBANCES; "UNHAPPY WITH OUTCOME". ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, DIB00, SAME DIOPTER). NO MEDICAL INTERVENTION WAS REQUIRED AND THERE WAS NO PATIENT INJURY. NO VITRECTOMY, SUTURE, OR INCISION ENLARGEMENT WAS REQUIRED. THE PATIENT IS FULLY RECOVERED. IT IS NOTED THAT INSTRUCTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 17901912 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WASN¿T HAPPY WITH THE QUALITY OF VISION DESPITE IMPLANT OF A PRELOADED MULTIFOCAL LENS IN PATIENT'S LEFT EYE. IT SEEMS LIKE VISON IS BLURRY. FURTHER FOLLOW-UP NOTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AFTER ALL. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES DONE. THIS WAS REPLACED WITH A DIB00 19.5. THE PATIENT WAS GOOD POST-EXPLANT AND NO INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 17844893 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WILL BE EXPLANTED IN TWO TO FOUR WEEKS. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE LENS WAS EXPLANTED FROM THE RIGHT EYE ON (B)(6) 2023 DUE TO BLURRY VISION AND HALOS AT NIGHT (DESPITE SPECTACLE CORRECTION). THE ISSUE STARTED IMMEDIATELY AFTER SURGERY, BUT IT WAS HOPED THAT THE PATIENT WOULD NEURO-ADAPT. THE PATIENT HAD STOPPED DRIVING AT NIGHT DUE TO THE VISUAL ISSUES. THE PATIENT'S PRE-OPERATIVE VISUAL ACUITY (VA) WAS 20/50. THE VA AFTER INITIAL IMPLANT WAS 20/20-1 (VERY BLURRY AND HAZY). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 16561296 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AS THE PATIENT WAS NOT HAPPY WITH THE MULTIFOCAL IMPLANT. THE PATIENT WAS NOT ABLE TO READ AND HAS TRIED FOR ALMOST A YEAR. THE PATIENT COMPLAINED OF POOR VISION, DYSPHOTOPSIA, AND NOT TOLERATING THE LENS. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REPORTED. THERE WAS NO PATIENT INJURY. A NON-JOHNSON & JOHNSON LIGHT ADJUSTABLE LENS WAS IMPLANTED AS A REPLACEMENT. THE PATIENT HAS RECOVERED. IT WAS NOTED THAT THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 15993072 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury; Visual Disturbances

  MAUDE report 15947239 ↗
• MalfunctionJul 21, 2022Break; Crack; Inaccurate Delivery; Break; Crack; Inaccurate Delivery

  IT WAS REPORTED THAT THE PRELOADED DEVICE HAD ISSUE IN DELIVERING THE INTRAOCULAR LENS (IOL) INTO PATIENT'S RIGHT EYE. THE LENS WAS NOT DELIVERING STRAIGHT AS IT SHOULD BE AND WAS COMING OUT CROOKED. THE CARTRIDGE TIP HAD ALSO CRACKED. IT WAS INDICATED THAT THE ISSUE WAS NOT DUE TO USE ERROR. THE LENS WAS PARTIALLY INSERTED INTO THE EYE WHICH THERE WAS PATIENT CONTACT, HOWEVER, WAS REMOVED. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH BACKUP LENS WITHOUT ANY ISSUES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15071402 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE PATIENT COMPLAINED OF SIGNIFICANT GLARES AND HALOS. THE IOL WAS EXPLANTED. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, EYHANCE) THERE WERE NO ISSUES DURING THE EXPLANT. THE PATIENT IS EXTREMELY HAPPY WITH THE RESULTS FROM THE NEW LENS. THE EXPLANTED IOL WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 15048476 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PRE-LOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2021. THE IOL WAS EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE ON (B)(6) 2021 DUE TO HALO AND VISION ISSUES OBSERVED DURING POST-OP EXAM. IT WAS REPORTED THE PATIENT IS TEMPORARILY IMPAIRED. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING IT IS UNKNOWN IF THE PATIENT WAS STILL TEMPORARILY IMPAIRED AFTER DFR00V 19.5 IOL EXCHANGE. IOL REPLACEMENT INFORMATION IS ALSO UNKNOWN, BUT THE EXPLANTED IOL WAS SENT BACK TO JJSV IN THE REPLACEMENT LENS BOX. PATIENT OUTCOME POST-LENS EXCHANGE IS ALSO UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 15023414 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO HALOS AND GLARE. ACCOUNT INDICATED THAT THE PATIENT WAS UNHAPPY. ANOTHER JOHNSON & JOHNSON AR40E LENS (DIFFERENT MODEL AND 19.0 DIOPTER) WAS IMPLANTED AS A REPLACEMENT IOL. A SUTURE WAS REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 14492980 ↗
• InjuryMay 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE AS THE PATIENT COMPLAINED THAT THE NEAR VISION WAS NOT WHAT THEY EXPECTED AND HAD NIGHT VISION GLARE. ANOTHER LENS OF DIFFERENT MODEL AND HIGHER DIOPTER (21.5D) WAS USED AS THE REPLACEMENT IOL. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING GOOD POST-OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 14465382 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING DOUBLE VISION AND GHOSTING WITH AN INTRAOCULAR LENS (IOL) IN BOTH EYES (OU). PATIENT WAS USING OVER-THE-COUNTER (OTC) EYE DROPS AND PRESCRIPTION DROPS AS WELL (STEROID & ANTIBIOTIC DROPS). PATIENT HAD A SECOND PROCEDURE DONE ON (B)(6) 2022 THAT THE PATIENT REFERRED TO AS A ¿JAG LASER¿ PROCEDURE TO REMOVE MEMBRANES FROM HIS EYES, HOWEVER, HE IS STILL EXPERIENCING SEEING DOUBLE-IMAGES. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE STEROID AND ANTIBIOTICS EYE DROPS WERE PRESCRIBED RIGHT AFTER THE SURGERY AS A STANDARD OF CARE. THE PATIENT IS ONLY TAKING OVER-THE-COUNTER (OTC) EYE DROPS TO HELP WITH THE DRY EYES. THE PATIENT REPORTED THE DRY EYES STARTED AFTER HE GOT THE IOL IMPLANTS. THE PATIENT ALSO COMPLAINED OF NOT BEING ABLE TO SEE CLEARLY AT ALL RANGES IN BOTH EYES. PATIENT INDICATED THAT IT IS HARD TO FOCUS CLOSE-UP WHICH AFFECTS HIS WORK, BECAUSE HE IS A CRAFTSMAN AND HIS WORK HAS GONE DOWN AS A RESULT. HE ALSO IS SEEING HALOS AND GLARE AROUND LIGHTS, SEES 10-15 RINGS AROUND LIGHTS SINCE THE IOL IMPLANTS IN BOTH EYES. THE DOUBLE VISION OU GETS WORSE WITH DISTANCE VISION. THE PATIENT STATED THAT THE YTTRIUM ALUMINUM GARNET (YAG) LASER

  Patient problems: Blurred Vision; Dry Eye(s); Halo; Visual Disturbances; Visual Impairment

  MAUDE report 14226106 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS HAD VISUAL ISSUES OF HAZY VISION. LASIK ENHANCEMENTS WERE DONE FOR BOTH IOLS (OU) TO BRING THEIR VISION INTO OPTIMAL FOCUS; HOWEVER, VISION IS STILL BLURRY AND PATIENT IS BEING TREATED FOR DRYNESS. IT WAS LEARNED THAT ABOUT TWO WEEKS POST-IMPLANT, THE RIGHT EYE (OD) ALSO DEVELOPED POOR NIGHT VISION AND ABOUT 8 MONTHS LATER THE IOL WAS EXPLANTED. A NON JOHNSON AND JOHNSON IOL WAS PLACED AS THE REPLACEMENT LENS. ACCOUNT INDICATED THAT A VITRECTOMY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 14161788 ↗
• MalfunctionNov 17, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING HANDLING, BUT PRIOR TO INSERTION, THE INTRAOCULAR LENS (IOL) HAPTIC BROKE OFF. THERE WAS NO PATIENT CONTACT REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12833357 ↗
• MalfunctionOct 21, 2021Material Too Rigid or Stiff; Scratched Material; Material Too Rigid or Stiff; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS LOADED PROPERLY; HOWEVER, THE PLUNGER HAD RESISTANCE WHEN ADVANCING. AFTER THE INSERTION OF LENS INTO PATIENT'S RIGHT EYE, IT WAS OBSERVED ON UNFOLDING THAT THE OPTIC WAS SCRATCHED AND THE SCRATCH WAS OUTSIDE THE VISUAL AXIS. THE LENS REMAINS IMPLANTED AND PATIENT HAS NOT EXPERIENCED ANY VISUAL DISTURBANCE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12677958 ↗
• MalfunctionOct 14, 2021Break; Break

  IT WAS REPORTED THAT UPON INSERTION OF THE TECNIS SYNERGY SIMPLICITY INTRAOCULAR LENS (IOL) INTO THE PATIENT'S LEFT (OS) EYE, A DEFECT WAS NOTED. THE OPTIC WAS CRACKED. THE LENS WAS REMOVED WITH MICRO CUTTERS AND MICRO FORCEPS WITHOUT INCIDENT. THE REPLACEMENT LENS IS A MODEL Z9002, 18.5 DIOPTER IOL. THE REPLACEMENT LENS WAS SAFELY PLACED IN THE SULCUS WITHOUT COMPLICATIONS. THE SURGERY DID NOT REQUIRE ANY EXTRA PROCEDURES SUCH AS ENLARGING THE INCISION, SUTURES, OR VITRECTOMY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12637356 ↗