TECNIS ODYSSEY IOL DRN00V (REF DRN00V0200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 05050474810761), received between Mar 29, 2024 and Sep 24, 2026 — classified as 21 injuries, 8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Blurred Vision; Halo; Pain; Visual Disturbances

  MAUDE report 50885505 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Halo; Visual Disturbances

  MAUDE report 50676585 ↗
• InjuryJun 23, 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 LEFT EYE DUE TO IMPLANTATION OF AN INCORRECT LENS POWER. THE LENS WAS REPLACED WITH A NON¿JOHNSON & JOHNSON MONOFOCAL INTRAOCULAR LENS (AOCO 19.0 D). NO COMPLICATIONS OR PATIENT HARM WERE REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 25603144 ↗
• MalfunctionMar 20, 2026Break

  IT WAS REPORTED THAT A SINGLE-PIECE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS CRACKED. THE PATIENT CAME INTO CONTACT WITH THE LENS. NO HARM WAS CAUSED TO THE PATIENT, AND NO SURGICAL INTERVENTION WAS NECESSARY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646622 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRN00V, WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE. FOLLOWING IMPLANTATION, THE PATIENT WAS DISSATISFIED WITH HER NEAR VISION. AS A RESULT, THE LENS WAS EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NON¿JOHNSON & JOHNSON LENS. NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24328970 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE FROM A PATIENT'S LEFT EYE. THE REASON FOR THE EXPLANT WAS NOT SPECIFIED. THE ISSUE WAS IDENTIFIED DURING AN POST-OP EXAMINATION. A NON-JOHNSON & JOHNSON LENS OF +18.50 DIOPTER WAS USED AS A REPLACEMENT. THERE WERE NO COMPLICATIONS SUCH AS UNPLANNED INCISION ENLARGEMENT, SUTURES, VITRECTOMY, OR PROCEDURAL DELAYS. THE PATIENT DAILY ACTIVITIES WERE NOT AFFECTED. NO MEDICAL ATTENTION OR MEDICATION OUTSIDE OF THE STANDARD OF CARE WAS REQUIRED. THE PATIENT DAILY ACTIVITIES WERE NOT AFFECTED. THE PATIENT HAS FULLY RECOVERED. DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24300160 ↗
• MalfunctionJan 2, 2026Scratched Material

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS FOUND TO HAVE A SCRATCH IN THE CENTER AFTER THE LENS WAS FULLY INSERTED IN THE LEFT EYE. THE LENS WAS REMOVED AND REPLACED WITH A NEW LENS OF THE SAME MODEL AND DIOPTER DURING THE SAME PROCEDURE. NO UNPLANNED VITRECTOMY, UNPLANNED SUTURES, OR INCISION ENLARGEMENT WERE REQUIRED. THERE WAS NO PATIENT INJURY AND NO DELAY IN THE PROCEDURE. THE PATIENT WAS ABLE TO PERFORM DAILY ACTIVITIES AS PRIOR TO SURGERY. THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23951430 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE DUE TO THE LENS BEING CHIPPED. THERE WAS NO PATIENT CONTACT. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818527 ↗
• InjuryDec 5, 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). POST-OPERATIVELY, THE PATIENT REPORTED HER VISION HAS NEVER FELT GOOD SINCE THE INITIAL SURGERY. SHE HAS ALWAYS NOTICED A "FUZZ" AROUND THE EDGE OF HER VISION AND WISHED HER VISION WAS BETTER, EYE FATIGUE SENSATION, AND HER DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THE IOL WAS EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE; THE INFORMATION REGARDING THE REPLACEMENT IOL WAS NOT PROVIDED. THERE WAS NO MEDICAL ATTENTION, NO SUTURES, AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT'S VISION PRE-OPERATIVE WAS 20/30-2 AND DESCRIBED AS FUZZY, POST-OPERATIVE RESULTS WERE NOT PROVIDED. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 23733534 ↗
• InjuryNov 19, 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 BLURRY VISION AND WAS BOTHERED BY HALOS AT NIGHT. THE ISSUES WERE FIRST NOTED DURING A POST-OPERATIVE EXAMINATION. THE LENS WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON IOL (+19.5 DIOPTER). NO UNPLANNED INCISION ENLARGEMENTS, SUTURES, VITRECTOMY, PROCEDURAL DELAYS, OR ADDITIONAL MEDICAL ATTENTION OR MEDICATIONS BEYOND THE STANDARD CARE WERE REPORTED. THE PATIENT¿S BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) WAS RECORDED AS 20/20 FOR BOTH PRE-OPERATIVE AND POST-OPERATIVE. IT WAS REPORTED THAT THE PATIENT WAS OVERCORRECTED BUT NOT UNDER CORRECTED AND THAT THERE WAS NO LOSS OF TWO OR MORE LINES OF BSCVA. THE INTENDED TARGET REFRACTION WAS -0.44. THE POST-OPERATIVE REFRACTION FOLLOWING THE LENS EXCHANGE WAS 20/50. THE PATIENT HAD A PRE-EXISTING CONDITION OF PRIMARY OPEN-ANGLE GLAUCOMA (POAG), WHICH AFFECTED THE CALCULATION. IT WAS REPORTED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 23595760 ↗
• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S LEFT EYE. AFTER IMPLANTATION AND UPON UNRAVELING OF THE LENS, A CRACK WAS IDENTIFIED. THE CRACKED IOL WAS REMOVED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER DURING THE SAME PROCEDURE. THERE WAS A DELAY IN PROCEDURE, BUT NO UNPLANNED VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES WERE REQUIRED. THE EVENT DID NOT IMPACT THE PATIENT¿S ACTIVITIES OF DAILY LIVING, AND THE PATIENT MADE A FULL RECOVERY. IT WAS NOTED THAT THE DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589468 ↗
• InjuryNov 12, 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 OPERATIVE EYE, THE PATIENT EXPERIENCED DIFFICULTY SEEING WELL AT A DISTANCE. THE LENS WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL (AR40 MODEL). IT IS UNKNOWN IF MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 23533196 ↗
• InjuryNov 4, 2025Ejection Problem; Ejection Problem

  THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS INSIDE OUT AND THERE WAS PATIENT CONTACT WITH THE PATIENT¿S OCULAR SINISTER (LEFT EYE). A VITRECTOMY WAS PERFORMED TO REMOVE LENS PART INSIDE THE EYE, LEAVING THE PATIENT APHAKIC AFTER THE PROCEDURE. USE ERROR DID NOT CONTRIBUTE TO THE ISSUE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23472819 ↗
• MalfunctionOct 31, 2025Scratched Material; Scratched Material

  A SCRATCH WAS NOTED ON THE CENTER OPTIC OF THE DRN00V MODEL INTRAOCULAR LENS (IOL) AFTER IT WAS IMPLANTED. THE SURGERY WAS COMPLETED IN THE SAME PROCEDURE AND THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442462 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT'S COMPLAINTS OF HALOS, NOT TRUSTING DEPTH PERCEPTION, AND DIFFICULTY DRIVING AT NIGHT. IT IS UNKNOWN IF ANY MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 23414566 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE. AFTER THE IMPLANTATION, A TEAR IN THE CAPSULE WAS IDENTIFIED, REQUIRING THE LENS TO BE EXPLANTED DURING THE SAME SURGERY. ENLARGEMENT OF INCISION AND VITRECTOMY WERE REQUIRED, AND THIS WAS UNPLANNED. IT WAS STATED THAT SUTURES ARE STANDARD PRACTICE AFTER THIS PROCEDURE. THE LENS WAS REPLACED DURING THE SAME PROCEDURE WITH A NON-JOHNSON & JOHNSON LENS OF +19.0 DIOPTER. NO MEDICATION OUTSIDE OF THE STANDARD OF CARE WAS REQUIRED. THE ACCOUNT IS UNCERTAIN IF THE PATIENT HAD ANY PRE-EXISTING ISSUES OR IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT IS CURRENTLY RECOVERING WELL WITH A MONOFOCAL IOL PLACED IN THE SULCUS, WITHOUT EXPERIENCING ANY TEMPORARY OR PERMANENT IMPAIRMENT AND DAILY ACTIVITIES HAVE NOT BEEN SIGNIFICANTLY AFFECTED. THE EXPLANTED LENS WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 23058377 ↗
• InjurySep 3, 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 DEXTER (RIGHT EYE). POST-OPERATIVELY, THE PATIENT IS REPORTING BLURRINESS FOLLOWING IMPLANTATION THAT IS SIGNIFICANTLY INTERFERING WITH HER DAILY ACTIVITIES. THE BLURRINESS IS CONSISTENT THROUGHOUT THE DAY AND THERE IS PERSISTENT CLOUDINESS HOWEVER, THE PATIENT CAN SEE NEAR AND FAR. A YTTRIUM ALUMINUM GARNET (YAG) PROCEDURE WAS PERFORMED ON BOTH OS AND OD IN (B)(6) 2025. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 22958236 ↗
• InjuryJul 15, 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). POST-OPERATIVELY, THE PATIENT EXPERIENCED NO NEAR VISION, THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON IOL, PANOPTIX PRO. THERE WAS NO INCISION ENLARGEMENT, NO PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. VISUAL ACUITY PRE-OPERATIVE WAS REPORTED AS 20/25 J10 AND POST-OPERATIVE 20/20 J10. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 22516114 ↗
• InjuryJun 16, 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 EYE AND REPLACED WITH A MONOFOCAL LENS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 22215679 ↗
• MalfunctionApr 30, 2025Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material

  A SURGEON REPORTED EXPERIENCING SLIGHT RESISTANCE WHILE INJECTING A MONOFOCAL INTRAOCULAR LENS (IOL) WHICH RESULTED IN THE IOL HAVING TWO LARGE SCRATCHES AND NEEDING TO BE REMOVED. WOUND WAS ENLARGED, AND A SUTURE WAS PLACED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21940228 ↗
• 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 21859397 ↗
• InjuryMar 5, 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 PATIENT NOT ADJUSTING TO THE MULTIFOCAL LENS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DIB00 19.5 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT STATUS POST LENS EXCHANGE WAS REPORTED AS PATIENT TOLERATED THE PROCEDURE WELL. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 21532056 ↗
• InjuryFeb 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE. DUE TO COMPLAINTS OF THE IOL BEING TILTED IN THE CAPSULAR BAG, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON IOL, ALCON 3 PIECE LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21361025 ↗
• MalfunctionFeb 11, 2025Scratched Material; Scratched Material

  AFTER THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS PLACED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) THE DOCTOR NOTICED A SCRATCH ON LENS. DURING THE SAME PROCEDURE, THE IOL WAS REMOVED AND REPLACED WITH ANOTHER IOL WITH THE SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTIONS DURING THE PROCEDURE. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS DOING WELL, NO COMPLICATIONS PER 07-JAN-2025 PROGRESS NOTE. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360450 ↗
• InjuryFeb 11, 2025Failure to Fold; Ejection Problem; Failure to Fold; Ejection Problem

  IT WAS REPORTED THAT THE LEADING HAPTIC ON THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) EJECTED PREMATURELY WHILE THE SURGEON WAS ADVANCING THE PLUNGER INTO THE EYE. THE SURGEON NOTED THAT THE HAPTIC WAS NOT FOLDED IN THE MIDDLE DURING THIS EVENT. THE CAPSULE TORE DURING INSERTION AND A VITRECTOMY WAS PERFORMED. A REPLACEMENT LENS WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 21358954 ↗