TECNIS ODYSSEY IOL DRN00V (REF DRN00V0205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05050474810778), received between Jan 9, 2025 and Mar 30, 2026 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED BLURRY DISTANCE AND NEAR VISION FOLLOWING THE FULL IMPLANTATION OF A SINGLE-PIECE PRELOADED TORIC EDOF INTRAOCULAR LENS (IOL) IN THE PATIENT¿S RIGHT EYE. THE ORIGINAL LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY ON THE SAME DAY. PREOPERATIVE BEST-CORRECTED VISUAL ACUITY (BSCVA) WAS 20/20, AND POSTOPERATIVE BSCVA REMAINED 20/20. DAILY ACTIVITIES WERE NOT AFFECTED. NO UNPLANNED SURGICAL INTERVENTIONS, SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY, WERE REQUIRED. NO MEDICATIONS OUTSIDE THE STANDARD OF CARE WERE PRESCRIBED, AND NO SURGICAL DELAYS WERE REPORTED. THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT EXPERIENCED TEMPORARY BILATERAL VISUAL IMPAIRMENT. ADDITIONAL INFORMATION WAS RECEIVED ON THE PATIENT'S LEFT EYE. THE DEVICE WAS REPORTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE PATIENT WAS NOTED TO BE UNDER-CORRECTED WITH NO LOSS OF TWO OR MORE LINES OF BEST SPECTACLE CORRECTED VISUAL ACUITY AND NO OVERCORRECTION. THE PRE-OPERATIVE REFRACTION WAS PLANO -1.00 X 85 WITH A POST-OPERATIVE REFRACTION OF +0.75 SPHERE AND AN INTENDED TARGET REFRACTION OF PLANO. A PRE-EXISTING CONDITION AFFECTING CALCULATION WAS

  Patient problems: Blurred Vision

  MAUDE report 24722077 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED OF A PATIENT WHO WAS UPSET WITH THE RESULTS AND HAD AN UNEXPECTED OUTCOME WITH THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL). THE DOCTOR HAD A PLAN TO PERFORM A LASER VISION CORRECTION TO TREAT THE PATIENT'S RESIDUAL REFRACTIVE ERROR. HE TARGETED A POSTOPERATIVE OUTCOME OF PLANO BUT RESULTED IN A REFRACTIVE OUTCOME OF ¿1.5. THE PATIENT HAD NO HISTORY OF PRIOR REFRACTIVE SURGERY, NO PRE-EXISTING OCULAR CONDITIONS, AND HAD NOT UNDERGONE ANY CORRECTIVE PROCEDURES SUCH AS LASIK. NO LOSS OF BSCVA (BEST SPECTACLE CORRECTED VISUAL ACUITY) WAS REPORTED WITH CORRECTION AND IT WAS STATED THAT THE PATIENT IS ABLE TO DRIVE. THE PATIENT¿S PRE-OPERATIVE REFRACTION WAS RECORDED AS -1.50+0.75X145, WITH A PRE-OPERATIVE BEST SPECTACLE-CORRECTED VISUAL ACUITY OF 20/30-1 AND A POST-OPERATIVE BEST SPECTACLE-CORRECTED VISUAL ACUITY OF 20/20+2. NO UNPLANNED MEDICAL OR SURGICAL INTERVENTIONS AT THE TIME OF LENS IMPLANTATION REPORTED. THROUGH FOLLOW UP IT WAS INDICATED THAT THE LENS WAS EXPLANTED FROM PATIENT¿S LEFT EYE ON (B)(6) 2026. THE REPLACEMENT LENS WAS A MONOFOCAL LENS, MODEL DCB00 WITH 20.5 DIOPTER. DURING THE EXPLANT NO UNPLANNED SURGICAL INTERVENTIONS, SUCH AS UNPLANNED VITR

  Patient problems: No Clinical Signs, Symptoms or Conditions; Visual Impairment

  MAUDE report 24671284 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRN00V WAS IMPLANTED INTO THE PATIENT'S LEFT EYE. THE PATIENT EXPERIENCED BLURRY VISION AT BOTH NEAR AND FAR DISTANCES, DESCRIBED AS A HYPEROPIC MISS. THE LENS WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH SAME MODEL BUT WITH A 1.5 DIOPTER CHANGE. PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/20-1 AND POST-OPERATIVELY WAS 20/40. REPORTEDLY THE PATIENT FULLY RECOVERED AFTER THE SECONDARY PROCEDURES. NO UNPLANNED INCISION ENLARGEMENT, SUTURES, VITRECTOMY, PROCEDURAL DELAYS, OR ADDITIONAL MEDICAL TREATMENT BEYOND STANDARD CARE WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24382835 ↗
• MalfunctionJan 8, 2026Device Difficult to Setup or Prepare; Scratched Material

  IT WAS REPORTED THAT THE SURGEON FELT RESISTANCE WHILE ADVANCING THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) AND DEEP SCRATCHES WERE IDENTIFIED ON THE OPTIC LEADING TO THE REMOVAL OF THE LENS. NO PATIENT HARM WAS NOTED IN THIS INSTANCE. THE LENS WAS CONFIRMED DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24012839 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT REPORTED THAT HE HAD ODYSSEY LENSES IMPLANTED APPROXIMATELY SIX MONTHS AGO AND IS DISSATISFIED. HE IS UNABLE TO SEE SMALL ITEMS SUCH AS HIS CELL PHONE OR COMPUTER SCREEN AND CANNOT READ THE NEWSPAPER. THE PATIENT NOTED THAT, ALTHOUGH HE EXPERIENCED GLARE BEFORE SURGERY, NIGHT DRIVING IS NOW IMPOSSIBLE. HE BECOMES NEARLY SNOW-BLIND AND DEVELOPS A BRIGHT, BLINDING SPOT THAT CAN OBSCURE VISION FOR UP TO FIVE MINUTES. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENS IMPLANTATION. THIS REPORT IS FOR THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

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

  MAUDE report 23899887 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S BOTH RIGHT EYE AND LEFT EYE. AFTER THE IMPLANT IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERFECT REFRACTIVE RESULT BUT SEVERE DYSPHOTOPSIA IN BOTH EYES THAT DID NOT IMPROVE OVER 3 MONTHS. THE IOLS WERE EXCHANGED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE RIGHT EYE. THE LEFT EYE IS BEING REPORTED IN MANUFACTURER REPORT NUMBER: 3012236936-2025-0003435.

  Patient problems: Visual Disturbances

  MAUDE report 23885829 ↗
• InjuryNov 24, 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 THE PATIENT¿S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO MECHANICAL COMPLICATIONS. THE PATIENT EXPERIENCED MULTIFOCAL INTOLERANCE WITH CONTRAST ISSUES AND GLARE, WHICH AFFECTED DAILY ACTIVITIES SUCH AS DRIVING AND READING. NO LOSS OF TWO OR MORE LINES OF BSCVA (BEST SPECTACLE-CORRECTED VISUAL ACUITY) WAS REPORTED. PRE-OP REFRACTION AND BSCVA WERE +0.75-0.25X090, 20/15; POST-OP WERE +1.00-0.50X80, 20/20-2. THE INTENDED TARGET REFRACTION WAS PLANO. IT WAS INDICATED THAT THE PATIENT HAD NO PRE-EXISTING CONDITION THAT WOULD HAVE AFFECTED THE CALCULATION. THE ACCOUNT SUSPECTS THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. A NON¿JOHNSON & JOHNSON LENS WAS IMPLANTED AS THE REPLACEMENT. NO UNPLANNED SURGICAL INTERVENTIONS (SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES) WERE REQUIRED, AND NO MEDICATIONS BEYOND THE STANDARD OF CARE WERE PRESCRIBED. THE PATIENT¿S STATUS DURING THE POSTOPERATIVE PERIOD WAS REPORTED AS NORMAL; AT TWO WEEKS POST-OP THE REFRACTION WAS +0.75 SPHERE 2./20. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 23640031 ↗
• InjuryNov 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE DURING A SECONDARY SURGICAL PROCEDURE FOR UNKNOWN REASONS. THE FOLLOWING ARE ALSO ALL UNKNOWNS: REPLACEMENT IOL INFORMATION AND PATIENT PROGNOSIS POST LENS EXPLANT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 23627960 ↗
• InjuryOct 30, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) DEPLOYED WITH FORCE. THE CUSTOMER EXPLAINED THAT THE IOL WAS HANDED TO THE SURGEON WITHOUT ANY PROBLEMS UNTIL HE BEGAN TO DEPLOY THE LENS. WHEN THE SURGEON WAS INITIATING PLACEMENT OF THE IOL, THE INSERTER DEPLOYED WITH FORCE ON THE SCLERA CAUSING A PUNCTURE WOUND. THE NURSE WAS ADVISED, AND THE PROCEDURE WAS COMPLETED WITH A BACKUP LENS. THE IOL DEPLOYED IN THE SCLERA SO IT WAS OUTSIDE THE EYE AND DIDN'T REACH INSIDE THE EYE SO THE CAPSULAR BAG WAS NOT DAMAGED. THE PATIENT OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION REGARDING THIS EVENT.

  Patient problems: Eye Injury

  MAUDE report 23432885 ↗
• 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 LEFT EYE DUE TO PATIENT EXPERIENCING FLUCTUATING VISION WHILE DRIVING, HALOS AT ALL TIMES OF DAY/NIGHT AND TOO BLURRY NEAR VISION. IT WAS NOTED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. REFRACTIONS AFTER CATARACT SURGERY WERE PRE-OPERATIVE: 20/40 AND POST-OPERATIVE: -0.25-0.50X060. 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, NO MEDICATION OUTSIDE THE STANDARD OF CARE AND NO PATIENT INJURY REPORTED. THE PATIENT OUTCOME STATUS IS GOOD AND PATIENT IS STILL IN POST-OPERATIVE CARE. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT UNDERWENT BILATERAL LENS IMPLANTATION. THIS EMDR REPORT PERTAINS TO THE LEFT EYE, AND A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 22822444 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE DUE TO PATIENT HAVING DIFFICULTY WITH NEAR VISION. PATIENT FIRST NOTICED STRUGGLING TO SEE COMPUTER AT 1 WEEK POST OPERATIVE (OP). AT 1 MONTH, THE NEAR VISION WAS STILL THE MAIN COMPLAINT WHICH THE PATIENT WAS UNABLE TO SEE HER PHONE OR COMPUTER AND COULD NOT DRIVE AT NIGHT BECAUSE OF THE HALOS WERE SO BAD, DESPITE SATISFACTORY DISTANCE VISION. AT 2 MONTHS POST OP, THE NEAR VISION WAS STILL BLURRY. AT 4 MONTHS POST OP, SAME COMPLAINT AND STARTED TO WEAR READERS +1.00 BUT DID NOT RESOLVE THE ISSUE. THE PATIENT ALSO EXPERIENCED ISSUES WITH DEPTH PERCEPTION AND EXPRESSED DISSATISFACTION, STATING THAT SHE FELT SHE HAD TRADED NEAR VISION FOR DISTANCE VISION. BY (B)(6) 2025, THE PATIENT REPORTED NO IMPROVEMENT IN HER NEAR OR INTERMEDIATE VISION. THEREFORE, THE IOL WAS EXPLANTED AND A REPLACEMENT LENS OF DIFFERENT MODEL AND DIOPTER (DXR00V +20.0D) WAS USED. NO MEDICAL OR SURGICAL INTERVENTION REQUIRED AND NO PATIENT INJURY NOTED. PATIENT AT 1-DAY POST IOL EXCHANGE, NEAR VISION (NV) 20/32, DOCTOR NOTED "CAN SEE HER COMPUTER". PRE-OPERATIVE FOR RIGHT EYE (OD): 20/60, MANIFEST REFRACTION (MR) OD:

  Patient problems: Blurred Vision; Halo

  MAUDE report 22778960 ↗
• InjuryJun 19, 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 EXPLANTED FROM THE PATIENT'S LEFT EYE AS THE PATIENT EXPERIENCED VARIOUS VISUAL DISTURBANCES, INCLUDING BLURRY VISION, HALOS, AND STREAKING DURING THE DAY AND NEGATIVE DYSPHOTOPSIA. THERE WAS NO PATIENT INJURY. THE BEST CORRECTED VISUAL ACUITY PRE-OP WAS 20/20 AND BEST CORRECTED VISUAL ACUITY POST-OP WAS 20/20+1. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 22290429 ↗
• InjuryJun 12, 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 BLURRY VISION, PATIENT WAS NOT HAPPY WITH VISION, AND VISUAL ACUITY ONLY WENT DOWN TO 20/40 POST LASIK, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON IOL. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS GOOD. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Discomfort

  MAUDE report 22199192 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENSES (IOL) WERE EXPLANTED FROM PATIENT'S LEFT AND RIGHT EYE AS THE PATIENT WAS UNABLE NEUROADAPT TO THE LENSES. THE LENSES WERE EXPLANTED AND REPLACED WITH A NON JNN LENSES IN A SECONDARY PROCEDURE. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 21971798 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD BILATERAL LENS IMPLANTATION IS EXPERIENCING HALOS AROUND LIGHTS AND POOR QUALITY OF VISION. THE DOCTOR PLANS TO SCHEDULE AN INTRAOCULAR LENS EXCHANGE FOR THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT PATIENT IOL'S (INTRAOCULAR LENS) WERE EXPLANTED. THEY WERE EXPLANTED DUE TO DYSPHOTOPSIA, COMPLAINTS OF POOR VISION DESPITE MINIMAL REFRACTIVE ERROR. LENS WERE REPLACED WITH LENS FROM ANOTHER MANUFACTURER (RXSIGHT LAL). THERE WAS NO PATIENT INJURY, IT WAS A STANDARD IOL EXCHANGE WITHOUT ANY ADDITIONAL INTERVENTIONS. PATIENT POST-OP WAS DOING VERY WELL, PATIENT NOTES RESOLUTION OF DYSPHOTOPSIA AND HALOS. NOTE: THIS CASE PERTAINS TO PATIENT'S RIGHT EYE. ANOTHER REPORT IS BEING SUBMITTED FOR PATIENT'S LEFT EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 21869155 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED ABOUT THE PRELOADED JOHNSON AND JOHNSON (JNJ) ODYSSEY INTRAOCULAR LENS (IOL). THE CUSTOMER HAD A PATIENT THAT IS EXTREMELY UNHAPPY WITH HIS VISION WITH THE ODYSSEY LENS TO THE POINT THAT THE PATIENT HAS HAD A TERRIBLE CAR ACCIDENT. THE SURGEON'S PLAN IS TO EXCHANGE HIS IOLS AND REPLACE THEM WITH VIVITY (A NON JOHNSON AND JOHNSON IOL). THE EXPLANTS HAVE NOT OCCURRED HOWEVER, THE SYMPTOMS WERE REPORTED AS DEBILITATING AS THERE ARE SEVERAL ACTIVITIES THAT THE PATIENT CAN NO LONGER PERFORM THAT THEY COULD PRIOR TO THE SURGERY. SOME OF THE ACTIVITIES ARE DRIVING, MOTORCYCLING AND READING. REPORTEDLY, THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES OR DELAYS IN PROCEDURE. THE END-USER DID NOT SEEK MEDICATION ATTENTION OUTSIDE THE STANDARD OF CARE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 21857432 ↗
• InjuryMar 31, 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 EXPLANTED FROM PATIENT'S RIGHT EYE AS THE PATIENT COMPLAINED OF DISTANCE VISION BEING BLURRY WITH HALOS AND STREAKING. THE LENS WAS EXPLANTED AND REPLACED WITH A LENS FROM ANOTHER MANUFACTURER IN A SECONDARY PROCEDURE. THE PATIENT'S STATUS WAS BETTER. FROM ADDITIONAL INFORMATION THE LENS HAD CONTRIBUTED FOR BLURRY VISION WITH HALOS AND STREAKING. THERE WAS HYPEROPIC MISS OF +0.4 DIOPTER. THERE WAS NO PATIENT INJURY. THERE WAS MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Flashers; Halo

  MAUDE report 21735586 ↗
• InjuryJan 9, 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 EXPLANTED DUE TO A PATIENT UNKNOWN COMPLAINT. PROCEDURE WAS COMPLETED WITH A ANOTHER MODEL J&J LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 21120994 ↗