TECNIS ODYSSEY IOL DRN00V (REF DRN00V0220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 05050474810808), received between Dec 3, 2023 and Sep 25, 2026 — classified as 18 injuries, 6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905084 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO POOR NEAR VISION, WHICH THE PATIENT EXPERIENCED GRADUALLY OVER THE PREVIOUS THREE MONTHS. IT WAS NOTED THAT THE PATIENT WAS UNABLE TO READ WELL. THE LENS WAS REPLACED WITH A NON¿JOHNSON & JOHNSON IOL OF THE SAME TYPE, WITH A POWER OF 23.5 DIOPTERS (D). NO UNPLANNED VITRECTOMY OR SUTURES WERE REQUIRED. THERE WAS NO PATIENT INJURY, SUCH AS A CAPSULE TEAR. NO MEDICATION WAS REQUIRED OUTSIDE THE REGULAR STANDARD OF CARE. THE CURRENT PATIENT OUTCOME WAS NOT PROVIDED. THE EXPLANTED LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 25491524 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRN00V, IMPLANTED IN THE PATIENT¿S LEFT EYE WAS REMOVED DUE TO PATIENT DISSATISFACTION RELATED TO GLARE AND HALOS. THE LENS WAS EXCHANGED FOR A TECNIS MONOFOCAL IOL. THE EXCHANGE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE COMPLAINT DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 25219845 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRN00V, WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE FOR AN UNKNOWN REASON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH IMPLANTATION OF A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER DIFFERENCE (DRN00V, +22.0 D). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24793316 ↗
• MalfunctionApr 6, 2026Scratched Material

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE PRELOADED INTRAOCULAR LENS (IOL) BEING SCRATCHED. THE IOL WAS IMPLANTED IN THE PATIENT'S RIGHT EYE. THE IOL WAS PREPARED BY THE NURSE WITH OPHTHALMIC VISCOELASTIC DEVICE (OVD) FROM A DIFFERENT MANUFACTURER AND IT WAS FILLED VIA THE HYDRATION PORT. THERE WAS NO RESISTANCE WHEN ADVANCING THE PLUNGER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793315 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) IN THE RIGHT EYE, THE PATIENT EXPERIENCED BLURRY VISION, HALOS, GLARE, AND OTHER VISUAL DISTURBANCES. THESE SYMPTOMS WERE FIRST NOTED APPROXIMATELY THREE MONTHS AFTER THE PROCEDURE. UPON EVALUATION, THE PATIENT¿S VISUAL METRICS WERE FOUND TO BE BELOW EXPECTED LEVELS, LEADING TO AN INTRAOCULAR LENS EXCHANGE WITH A DIB00 LENS OF 21.5 DIOPTERS. NO HARM TO THE PATIENT WAS REPORTED. THE PRODUCT IS UNAVAILABLE FOR RETURN OR FURTHER INVESTIGATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 24587174 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S LEFT EYE DUE TO THE PATIENT EXPERIENCING HALOS AND GLARE. A DIFFERENT LENS MODEL, DCB00 WITH A POWER OF 22.0 DIOPTERS, WAS SUCCESSFULLY IMPLANTED AS THE REPLACEMENT. NO ADDITIONAL MEDICAL INTERVENTIONS SUCH AS VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT WERE REQUIRED DURING THE PROCEDURE, AND NO PATIENT INJURY WAS REPORTED. NO MEDICATIONS OUTSIDE THE STANDARD OF CARE WERE PRESCRIBED, AND NO FURTHER SURGICAL INTERVENTIONS ARE PLANNED. THE PATIENT¿S CURRENT POSTOPERATIVE OUTCOME IS NOT AVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 24585096 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO WEEKS AFTER CATARACT SURGERY AND THE IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL), THE PATIENT'S MYOPIA GRADUALLY INCREASED TO -4.0D (REFRACTIVE INDEX) AND -3.0D (SUBJECTIVE). THE PATIENT COMPLAINED OF BEING UNABLE TO SEE. THE IOL WAS EXPLANTED ON (B)(6), AND A REPLACEMENT IOL WAS IMPLANTED. THE POSTOPERATIVE REFRACTION AFTER REMOVAL AND REPLACEMENT WAS -0.5D, WHICH WAS AS INTENDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 24254970 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOLS), MODEL DRN00V, THE PATIENT EXPERIENCED AN UNSPECIFIED INJURY IN THE LEFT EYE. LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE. NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, SURGICAL DELAYS, OR MEDICATIONS OUTSIDE OF STANDARD CARE WERE REQUIRED. THE PATIENT¿S BEST CORRECTED VISUAL ACUITY REMAINED 20/20 BOTH EYES BEFORE AND AFTER THE PROCEDURES. THE PATIENT REPORTED TEMPORARY VISUAL IMPAIRMENT, INCLUDING AN INABILITY TO DRIVE AT NIGHT AFTER THE PRIMARY SURGERY. REPLACEMENT LENS IMPLANTED IN LEFT EYE WAS NON¿JOHNSON & JOHNSON PRODUCTS. POST OPERATIVE REFRACTION FOR THE REPLACEMENT LENS HAS NOT YET BEEN MEASURED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24254809 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE AS THE PATIENT WAS NOT HAPPY WITH THE LENS AND WANTED IT REPLACED. THE INTRAOCULAR LENS WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT UNDERWENT BILATERAL LENS IMPLANTATION. THIS REPORT PERTAINS TO THE RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

  Patient problems: Discomfort; Visual Disturbances

  MAUDE report 23992596 ↗
• MalfunctionDec 19, 2025Scratched Material; Scratched Material

  IOL SN:(B)(6). MARKS RESEMBLING A GASH ON THE CENTRAL OPTIC OF THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS NOTED AFTER ITS IMPLANTATION IN THE PATIENT'S OPERATIVE EYE. THE IOL WAS REMOVED DURING THE SAME PROCEDURE AND REPLACED WITH ANOTHER DRN00V 22.0 DIOPTER IOL. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTION. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847062 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE, THE PATIENT COMPLAINED OF DIFFICULTY FOCUSING AND VISION BEING BLURRY EVERYWHERE. THE ISSUE WAS IDENTIFIED DURING A POST-OPERATIVE EXAMINATION. THE LENS WAS SUBSEQUENTLY EXPLANTED IN A SECONDARY SURGERY. A NON-JOHNSON & JOHNSON IOL WITH +22.5 DIOPTER WAS IMPLANTED AS REPLACEMENT. NO UNPLANNED INCISION ENLARGEMENT, SUTURES, VITRECTOMY, OR PROCEDURAL DELAYS OCCURRED. NO ADDITIONAL MEDICAL INTERVENTION OR MEDICATION BEYOND THE STANDARD OF CARE WAS REQUIRED. THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT¿S PRE-OPERATIVE BEST SPECTACLE-CORRECTED VISUAL ACUITY (BSCVA) WAS 20/20-1, AND 20/30+J5 POST-OPERATIVELY. THE INTENDED TARGET REFRACTION WAS -0.40. THE PATIENT WAS UNDER-CORRECTED BUT DID NOT LOSE TWO OR MORE LINES OF BSCVA. THE PATIENT DID NOT HAVE ANY PRE-EXISTING CONDITION THAT AFFECTED CALCULATION. THE PATIENT¿S POST-OPERATIVE REFRACTION AFTER THE LENS EXCHANGE WAS 20/20-1. THE PATIENT HAS FULLY RECOVERED. IT IS UNKNOWN IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 23833111 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DUE TO COMPLAINTS OF HALOS THAT AFFECTED THE PATIENT'S ABILITY TO DRIVE AT NIGHT, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS WITH SN: (B)(6). THERE WAS NO MEDICAL INTERVENTION SUCH AS INCISION ENLARGEMENT, SUTURES, AND VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo

  MAUDE report 23786174 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), IT WAS NOTICED THAT THERE WAS A CRACK ON THE OPTIC. THE LENS WAS IMPLANTED BUT SUBSEQUENTLY REMOVED AND SUCCESSFULLY REPLACED WITH ANOTHER IOL DURING THE SAME PROCEDURE. THERE WERE NO RESISTANCE EXPERIENCED DURING DELIVERY, AND BALANCED SALT SOLUTION (BSS) WAS USED AS THE LUBRICANT. THERE WAS NO SHIPPING OR PACKAGING DAMAGE, OR BREACHES IN THE STERILE BARRIER OF THE DEVICE. NO FOREIGN MATERIAL WAS INTRODUCED INTO THE EYE. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696076 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO TOLERATE GLARE AND HALOS AFTER THE IMPLANTATION OF THE PRELOADED MULTIFOCAL INTRAOCULAR LENSES (IOLS) IN BOTH EYES. THE LENSES WERE SUBSEQUENTLY EXPLANTED AND REPLACED WITH NON-JOHNSON AND JOHNSON IOLS. IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY PERFORMING ONE OR MORE DAILY ACTIVITIES FOLLOWING THE SURGERY. THE PATIENT WAS DISSATISFIED WITH THE LENSES, WHICH WERE NOTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. IT IS UNKNOWN IF THE PATIENT EXPERIENCED A LOSS OF TWO OR MORE LINES OF BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) OR IF THE PATIENT WAS UNDER OR OVER CORRECTED. THE PATIENT¿S PRE-OPERATIVE AND POST-OPERATIVE REFRACTION, BSCVA, AND THE INTENDED TARGET REFRACTION WERE ALSO UNKNOWN. THERE WERE NO PRE-EXISTING CONDITIONS THAT AFFECTED CALCULATION. NO UNPLANNED SURGICAL INTERVENTIONS OR MEDICATION OUTSIDE THE STANDARD OF CARE WAS REQUIRED. IT WAS REPORTED THAT THE PATIENT'S OUTCOME WAS ¿AS EXPECTED¿. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO CAPTURE THE LEFT EYE EVENT. A SEPARATE REPORT WILL BE SUBMITTED TO CAPTURE THE RIGHT EYE EVENT.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 23554291 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO TOLERATE GLARE AND HALOS AFTER THE IMPLANTATION OF THE PRELOADED MULTIFOCAL INTRAOCULAR LENSES (IOLS) IN BOTH EYES. THE LENSES WERE SUBSEQUENTLY EXPLANTED AND REPLACED WITH NON-JOHNSON AND JOHNSON IOLS. IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY PERFORMING ONE OR MORE DAILY ACTIVITIES FOLLOWING THE SURGERY. THE PATIENT WAS DISSATISFIED WITH THE LENSES, WHICH WERE NOTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. IT IS UNKNOWN IF THE PATIENT EXPERIENCED A LOSS OF TWO OR MORE LINES OF BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) OR IF THE PATIENT WAS UNDER OR OVER CORRECTED. THE PATIENT¿S PRE-OPERATIVE AND POST-OPERATIVE REFRACTION, BSCVA, AND THE INTENDED TARGET REFRACTION WERE ALSO UNKNOWN. THERE WERE NO PRE-EXISTING CONDITIONS THAT AFFECTED CALCULATION. NO UNPLANNED SURGICAL INTERVENTIONS OR MEDICATION OUTSIDE THE STANDARD OF CARE WAS REQUIRED. IT WAS REPORTED THAT THE PATIENT'S OUTCOME WAS ¿AS EXPECTED¿. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO CAPTURE THE RIGHT EYE EVENT. A SEPARATE REPORT WILL BE SUBMITTED TO CAPTURE THE LEFT EYE EVENT.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 23554286 ↗
• InjurySep 7, 2025Adverse 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 EXPLANTED FROM THE PATIENT'S LEFT EYE. THE IOL WAS EXPLANTED BECAUSE THE PATIENT STATED HE COULD NOT SEE ANYTHING, STILL NEEDED BIFOCALS FOR EVERYTHING, THE NIGHT HALOS WERE VERY BAD, AND THEIR EYES HURT A LOT. THE IOL WAS REPLACED WITH NON- JOHNSON AND JOHNSON MODEL LI61AO +22.5. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE. THERE WAS NO CAPSULE TEAR, VITRECTOMY, OR SUTURES. THE CUSTOMER INDICATED THAT THE EXPLANTED PRODUCT HAS ALREADY BEEN RETURNED TO JNJ. NO FURTHER INFORMATION WAS PROVIDED. NOTE, THIS REPORT CAPTURES THE LEFT EYE. THE RIGHT EYE IS BEING REPORTED IN MANUFACTURER REPORT NUMBER 3012236936-2025-0002331.

  Patient problems: Blurred Vision; Eye Injury; Eye Pain; Halo

  MAUDE report 22989593 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE DUE TO PATIENT EXPERIENCING OCULAR HEADACHES, FLUCTUATING VISION WHILE DRIVING, HALOS AT ALL TIMES OF DAY/NIGHT AND VERY BLURRY NEAR VISION. IT WAS NOTED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. REFRACTIONS AFTER CATARACT SURGERY WERE PRE-OPERATIVE: 20/25 -2 AND POST-OPERATIVE: -0.75 SPH. THE REPLACEMENT LENS WAS A NON-JOHNSON & JOHNSON LIGHT ADJUSTABLE LENS. IT WAS INDICATED THAT LASIK WAS DONE BEFORE EXPLANT IN AN ATTEMPT TO KEEP THE ORIGINAL IMPLANTED LENS. THERE WERE NO OTHER SURGICAL INTERVENTIONS SUCH AS SUTURES, NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS REQUIRED AND NO PATIENT INJURY REPORTED. THE PATIENT OUTCOME STATUS IS GOOD AND PATIENT STILL GOING THROUGH POST-OPERATIVE HEALING PERIOD. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT UNDERWENT BILATERAL LENS IMPLANTATION. THIS EMDR REPORT PERTAINS TO THE RIGHT EYE, AND A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Halo; Headache

  MAUDE report 22822440 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE DUE TO PATIENT EXPERIENCING SYMPTOMS OF DARK VISION, POOR NIGHT VISION, GLARE, AND HALOS, WHICH BEGAN ONE WEEK POSTOPERATIVELY AND PERSISTED FOR FIVE MONTHS. A NON-JOHNSON & JOHNSON LENS (+20.0D) WAS USED AS THE REPLACEMENT. REPORTEDLY, THE PATIENT IS HAPPIER WITH VISION WITH NEW LENS. IT WAS NOTED THAT THE LENS WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 22779038 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT'S VISION WAS 20/40 AND A LIMBAL RELAXATION INCISIONS (LRI) WAS PERFORMED FOR ASTIGMATISM. POST-OPERATIVELY, THE PATIENT REPORTED BLURRY VISION, THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRT150 22.5 DIOPTER IOL. THERE WAS NO COMPLICATIONS, NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST IOL EXCHANGE IS UNKNOWN. AN APPOINTMENT WAS SCHEDULED FOR (B)(6) 2025. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21983067 ↗
• InjuryMar 17, 2025Adverse 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 IMPLANTED IN PATIENT'S EYE FEW MONTHS AGO AND THERE WAS NEED FOR EXCHANGE OF THE LENS BECAUSE THERE WAS A MISS. THERE WAS A PLAN OF EXCHANGE OF THE ODYSSEY LENS WITH A NEW LENS AFTER WEEKS WITH ADJUSTED POWER. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 21627500 ↗
• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED LENS HAD DAMAGE. ADDITIONAL INFORMATION REVEALED THAT THERE WAS LENS CONTAMINATION, SO THE PROCEDURE WAS COMPLETED USING ANOTHER JOHNSON & JOHNSON LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21278320 ↗
• MalfunctionJun 18, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT WHEN THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED THE HAPTICS DIDN'T DEPLOY ALL THE WAY UNTIL THE DOCTOR HAD MANUALLY PUSHED THE HAPTIC OUT WITH A SINSKEY DEVICE. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE LENS WAS IMPLANTED IN THE EYE WITH ADDITIONAL MANEUVERS USING SINSKY DEVICE AND THE LENS REMAINS IMPLANTED IN THE EYE. THE ISSUE WAS NOTICED DURING APPLICATION/IMPLANTATION OF THE LENS. THE LENS WAS FULLY IMPLANTED. THERE WAS NO USE ERROR. THERE WERE NO VISUAL ISSUES AND THE PATIENT DAILY ACTIVITIES WERE NOT AFFECTED. OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564069 ↗
• InjuryDec 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). PATIENT REPORTED DURING POST-OPERATIVE EXAM OF BEING EXTREMELY BOTHERED BY STARBURSTS AND THAT HE IS UNABLE TO DRIVE AT NIGHT. THERE ARE NO PLANS FOR MEDICAL OR SURGICAL INTERVENTION TO ADDRESS REPORTED ISSUES. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Flashers

  MAUDE report 18253569 ↗