TECNIS ODYSSEY IOL DRN00V (REF DRN00V0225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05050474810815), received between Oct 27, 2023 and May 28, 2026 — classified as 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (2 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS ASSOCIATED WITH PERSISTENT HALOS WHEN VIEWING HEADLIGHTS OR OTHER LIGHTS AT NIGHT, ALONG WITH DRYNESS, PARTICULARLY UPON WAKING, AND NO ASSOCIATED PAIN. THE REPORTED ISSUES INCLUDED BLURRY VISION, HALOS OR GLARE, AND VISUAL DISTURBANCES, WHICH WERE NOTED DURING A POSTOPERATIVE EXAMINATION. ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT AN INTRAOCULAR LENS (IOL) EXPLANTATION WAS PERFORMED ON THE RIGHT EYE OF THE PATIENT. THE PREOPERATIVE REFRACTION WAS +1.25 -0.75 × 095, AND THE POSTOPERATIVE REFRACTION WAS +0.25 -0.50 × 069, WITH A TARGET OF PLANO. THE REPLACEMENT LENS IMPLANTED WAS A NON-JOHNSON & JOHNSON LENS WITH A POWER OF +22.0 DIOPTERS. DURING THE EXPLANT PROCEDURE, THERE WERE NO UNPLANNED SURGICAL INTERVENTIONS. NO PATIENT INJURY WAS REPORTED. THE PATIENT EXPRESSED SATISFACTION WITH THE NEW LENS, AND THE OVERALL PATIENT OUTCOME WAS REPORTED AS GOOD. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 25322288 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPRESSED DISSATISFACTION WITH A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), CITING DYSPHOTOPSIA AND SUBOPTIMAL VISUAL OUTCOMES. THE PATIENT INITIALLY PRESENTED WITH A VISUAL ACUITY OF 20/100, WHICH IMPROVED TO 20/70 FOLLOWING THE MOST RECENT MANIFEST REFRACTION; HOWEVER, THE PATIENT REMAINED DISSATISFIED WITH THE OUTCOME. AN ATTEMPT WAS MADE BY THE SURGEON TO EXPLANT AND REPLACE THE LENS; HOWEVER, THE PROCEDURE WAS NOT COMPLETED DUE TO INTRAOPERATIVE IDENTIFICATION OF DELICATE ZONULES, AND THE IOL WAS LEFT IN THE PATIENT'S EYE. THE APPROXIMATE DATE OF THIS ATTEMPTED PROCEDURE WAS REPORTED AS EARLY APRIL. THE CAUSE OF THE REDUCED POSTOPERATIVE VISUAL ACUITY (VA) IS UNKNOWN, AND IT IS UNCLEAR WHETHER THE REPORTED VA OF 20/70 WAS BEST-CORRECTED OR UNCORRECTED. THE PATIENT IS NOT REPORTED TO HAVE A DEBILITATING CONDITION BUT REMAINS DISSATISFIED WITH THE LENS. IT IS ALSO UNKNOWN WHETHER THE PATIENT HAD ANY PRE-EXISTING OCULAR CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE OUTCOME. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 25154169 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED GLARE AND HALO SYMPTOMS FOLLOWING IMPLANTATION OF A SINGLE-PIECE, PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) INTO THE PATIENT'S RIGHT EYE. ALTHOUGH THE PATIENT¿S REFRACTION WAS 20/20, THE PATIENT WAS COMPLAINING OF NOT BEING ABLE TO SEE CLEARLY. THE ORIGINAL LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY PROCEDURE AND REPLACED WITH A THREE-PIECE, NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 24781109 ↗
• MalfunctionMar 12, 2026Scratched Material

  THE PLUNGER TIP OF THE DRN00V MODEL INTRAOCULAR LENS (IOL) SCRAPED AGAINST THE RIGHT SIDE OF THE CARTRIDGE WALL, THUS SCRATCHING THE LENS. THE INCISION WAS ENLARGED AND THE IOL WAS REMOVED HOWEVER, THERE WAS NO SERIOUS PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP DRN00V 22.5 IOL THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS GREAT. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 24587246 ↗
• 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 LEFT 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 LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Discomfort; Visual Disturbances

  MAUDE report 23992666 ↗
• MalfunctionDec 19, 2025Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT AFTER INSERTION OF A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), THE DEVICE FAILED TO SEAT PROPERLY AND TORE. IT WAS INITIALLY SUSPECTED THAT THE TEAR OCCURRED DURING MANIPULATION TO ACHIEVE PLACEMENT BUT THE SURGEON LATER NOTED THE LEADING HAPTIC APPEARED IRREGULAR PRIOR TO INSERTION. BECAUSE THE HAPTIC DID NOT FUNCTION AS INTENDED, THE SURGEON WAS UNABLE TO SEAT THE LENS AND THE HAPTIC BROKE OFF. THE DAMAGED IOL WAS EXPLANTED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER WITHOUT COMPLICATION. NO UNPLANNED SURGICAL INTERVENTIONS (E.G., VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES) WERE REQUIRED, AND THE PATIENT IS REPORTED TO BE IN VERY GOOD CONDITION WITH NO INJURY OR USER HARM. THE OPHTHALMIC VISCOELASTIC DEVICE (OVD) USED WAS AT OPERATING-ROOM TEMPERATURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857760 ↗
• InjuryOct 17, 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 EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO AN UNKNOWN REASON. THE REPLACEMENT LENS IS THE SAME JOHNSON AND JOHNSON IOL MODEL, DRN00V 21.5 DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE, VITRECTOMY, OR SUTURES. THE OPHTHALMIC VISCOSURGICAL DEVICE (OVD) USED IS DUOVISC. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 23330331 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A TECNIS ODYSSEY SIMPLICITY 22.0D INTRAOCULAR LENS (IOL) IMPLANTED ON (B)(6) 2025 IN THE LEFT EYE (OS). PATIENT PRESENTED POST OP WITH HYPEROPIC SURPRISE AND LENS WAS EXPLANTED ON (B)(6) 2025. DURING EXPLANT PROCEDURE, A DIFFERENT MODEL, THE OPTIBLUE EXTENDED DEPTH OF FOCUS (EDOF) 23.0D LENS, WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL MEDICAL INTERVENTIONS, SUCH AS VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT, WERE REQUIRED. THE PATIENT IS REPORTED TO BE DOING WELL FOLLOWING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 22959366 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS WAS EXPLANTED DUE TO HALOS. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH AN UNKNOWN INTRAOCULAR LENS (IOL). THE PATIENT REQUIRED INCISION ENLARGEMENT AND SUTURES. THE PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 22180561 ↗
• InjuryJun 2, 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 WAS BEING INTOLERANT TO MULTIFOCAL LENS, BUT HAD PLANS TO CONTINUE USING MORE TECNIS ODYSSEY LENSES. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 22128270 ↗
• InjuryMay 22, 2025Application Program Problem: Dose Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings; Application Program Problem: Dose Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ODYSSEY INTRAOCULAR LENS (IOL) 22.0D WAS EXPLANTED IN SECONDARY PROCEDURE AND REPLACED WITH SAME MODEL LENS WITH 23.5D. PATIENT HAD TROUBLE READING DUE TO WRONG POWER IOL. THERE WAS UNPLANNED INCISION ENLARGEMENT. UNPLANNED SUTURES WERE REQUIRED. PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY (BSCVA) WAS 20/20 AND POST-OPERATIVE BSCVA WAS 20/20. PATIENT WAS TEMPORARILY IMPAIRED. NO UNPLANNED VITRECTOMY WAS REQUIRED. THERE WAS NO DELAY IN PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Flashers

  MAUDE report 22074099 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED LENS WAS EXPLANTED BECAUSE THE PATIENT WAS NOT SATISFIED WITH NEAR AND COMPUTER VISION, EXPERIENCED SIGNIFICANT HALOS AT NIGHT, AND FOUND DRIVING AT NIGHT UNCOMFORTABLE. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH ANOTHER J&J LENS. THE PATIENT'S VISUAL ACUITY IS NOW 20/20, AND THEY HAVE FULLY RECOVERED. NO FURTHER INJURIES OR INTERVENTIONS ARE REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 22007066 ↗
• MalfunctionFeb 23, 2025Scratched Material; Scratched Material

  THE DOCTOR NOTICED INDENTATIONS ON THE OPTIC OF THE PRE-LOADED DRN00V MODEL INTRAOCULAR LENS (IOL). THE SURGERY WAS COMPLETED IN THE SAME PROCEDURE AND THERE WAS NO PATIENT INJURY. IT WAS STATED DAMAGED PRODUCT RECEIVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442749 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRE-LOADED DRN00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DUE TO COMPLAINTS OF DISTANCE VISION AND MYOPIC MISS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRN00V 21.5 DIOPTER IOL. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTION PERFORMED DURING THE LENS EXCHANGE PROCEDURE. PATIENT STATUS POST LENS EXCHANGE WAS REPORTED AS SLIGHTLY IMPROVED VISION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21332533 ↗
• MalfunctionAug 22, 2024Contamination; Contamination

  IT IS REPORTED THAT A BUNDLE OF FIBERS WAS OBSERVED ON THE MULTIFOCAL INTRAOCULAR LENS, WITH SOME FIBERS APPEARING TO BE WRAPPED AROUND THE OPTIC. THE LENS WAS NOT EXPLANTED AND REMAINS IN THE PATIENT'S EYE. ADDITIONAL INFORMATION SUGGESTS THAT THIS OBSERVATION WAS MADE DURING IMPLANTATION/APPLICATION. NO INJURY OR INTERVENTION WAS REQUIRED HOWEVER REQUIRED EXTRA TIME TO REMOVED FIBERS. THE STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20042691 ↗
• InjuryOct 27, 2023Adverse 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 BECAUSE THE PATIENT COMPLAINED OF DYSPHOTOPSIA. THE EXPLANTED IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 18026164 ↗