TECNIS ODYSSEY IOL DRN00V (REF DRN00V0210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 05050474810785), received between Apr 11, 2024 and Sep 25, 2026 — classified as 26 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 37 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 50902755 ↗
• MalfunctionSep 8, 2026Scratched Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50680136 ↗
• MalfunctionJul 27, 2026Mechanical Jam; Scratched Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50002696 ↗
• InjuryJun 2, 2026Adverse 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 RIGHT EYE. THE PATIENT EXPERIENCED BLURRY VISUAL ACUITY, TROUBLE FOCUSING, HALOS AND GLARE. THE IOL WAS EXPLANTED AND REPLACED WITH A NON- JOHNSON AND JOHNSON LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 25365550 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE DUE TO THE PATIENT COULD NOT TOLERATE THE DIFFRACTIVE LENS TECHNOLOGY DESPITE WAITING MANY MONTHS. THE PATIENT EXPERIENCED BLURRY VISION AND POOR VISUAL QUALITY. NO PATIENT HARM WAS REPORTED. THROUGH FOLLOW-UP, IT WAS REPORTED THAT THE LENS WAS REPLACED WITH A NON¿JOHNSON & JOHNSON LENS. THE PATIENT WAS ABLE TO PERFORM DAILY ACTIVITIES PRIOR TO SURGERY. THERE WAS NO LOSS OF TWO OR MORE LINES OF BSCVA (BEST SPECTACLE-CORRECTED VISUAL ACUITY), AND THE PATIENT WAS NEITHER OVERCORRECTED NOR UNDERCORRECTED. PREOPERATIVE REFRACTION WAS +1.50 SPHERE WITH A BSCVA OF 20/30. POSTOPERATIVE REFRACTION WAS PLANO SPHERE WITH A BSCVA OF 20/20. THE INTENDED TARGET REFRACTION WAS PLANO. THERE WERE NO PRE-EXISTING CONDITIONS THAT AFFECTED THE IOL CALCULATION. NO UNPLANNED SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES WERE REQUIRED. NO MEDICATIONS OUTSIDE THE STANDARD OF CARE WERE PRESCRIBED. THE PATIENT HAD A SINGLE-VISION LENS IN THE OTHER EYE AND IS MUCH HAPPIER WITH THE QUALITY OF VISION WITH THE SINGLE-VISION LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24676948 ↗
• MalfunctionMar 14, 2026Scratched Material

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRN00V WAS IMPLANTED INTO THE PATIENT'S LEFT EYE WHICH WAS FOUND TO BE SCRATCHED DURING THE PROCEDURE. THE LENS WAS REMOVED, AND IT APPEARS THAT THE INSERTER MAY HAVE SCRAPED THE LENS. THE PATIENT WAS NOT INJURED. THE COMPLAINT DEVICE WAS DISCARDED. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE LENS WAS FULLY INSERTED INTO THE PATIENT¿S LEFT EYE AND WAS FOUND TO HAVE A SCRATCH IN THE CENTER OF THE OPTIC. THE LENS WAS SUBSEQUENTLY REMOVED AND REPLACED DURING THE SAME PROCEDURE USING A BACK-UP LENS OF THE SAME MODEL AND DIOPTER. A SUTURE WAS PLACED DUE TO THE ENLARGED INCISION, WHICH IS STANDARD PRACTICE WHEN THE INCISION CANNOT EFFECTIVELY SELF-SEAL AFTER AN INTRAOCULAR LENS IS REMOVED. IT IS UNKNOWN WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT; HOWEVER, THE LENS WAS ADVANCED NORMALLY THROUGH THE PRELOADED CARTRIDGE AND INJECTOR WITH THE CORRECT VISCOELASTIC, AND IT APPEARED SCRATCHED IMMEDIATELY UPON INSERTION. AT THE ONE-WEEK POSTOPERATIVE FOLLOW-UP, THE SUTURE WAS REMOVED, AND THE PATIENT ACHIEVED 20/20-1 VISION IN THE OPERATED EYE. THE PATIENT CONTINUES TO BE MONITORED.

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

  MAUDE report 24600368 ↗
• InjuryFeb 13, 2026Adverse 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, DUE TO COMPLAINTS OF SEVERE POSITIVE DYSPHOTOPSIA THAT WAS OBSERVED APPROXIMATELY ONE MONTH AFTER THE RIGHT EYE SURGERY, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A ZCB00 21.0 IOL. THERE WAS NO INCISION ENLARGEMENT AND NO SERIOUS INJURY DURING THE IOL EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST PROCEDURE WAS REPORTED AS GOOD AND VISUAL ACUITY SC WAS 20/30. THE SUSPECT IOL IS NOT AVAILABLE FOR INVESTIGATION AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Flashers

  MAUDE report 24340075 ↗
• InjuryFeb 13, 2026Adverse 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, DUE TO COMPLAINTS OF SEVERE POSITIVE DYSPHOTOPSIA THAT WAS OBSERVED APPROXIMATELY ONE MONTH AFTER THE EYE SURGERY, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A ZCB00 21.0 IOL. THERE WAS NO INCISION ENLARGEMENT AND NO SERIOUS INJURY DURING THE IOL EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST PROCEDURE WAS REPORTED AS GOOD AND VISUAL ACUITY SC WAS 20/30. THE SUSPECT IOL IS NOT AVAILABLE FOR INVESTIGATION AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Flashers

  MAUDE report 24340057 ↗
• MalfunctionFeb 11, 2026Break; Device Difficult to Setup or Prepare; Failure to Advance

  IT WAS REPORTED THAT WHEN ATTEMPTING TO LOAD A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRN00V, THE LENS APPEARED TO BE TOO TIGHT AND BECAME CRUMPLED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311094 ↗
• InjuryFeb 5, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT FULLY INSERTED SINGLE PIECE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO A MECHANICAL COMPLICATION OF THE LENS. THE DATE OF THE EVENT WAS UNKNOWN. THERE WERE NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE REPLACEMENT USED WAS A SINGLE PIECE PRELOADED MONOFOCAL WITH A DIOPTER OF 21.5. NO UNPLANNED SURGICAL INTERVENTIONS SUCH AS, INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED. NO MEDICATION PRESCRIBED THAT WAS OUTSIDE OF THE STANDARD OF CARE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY HOWEVER PATIENT OUTCOME IS NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273896 ↗
• MalfunctionFeb 2, 2026Break

  UPON INSERTION, A CRACK WAS OBSERVED IN THE MIDDLE OF THE DRN00V MODEL INTRAOCULAR LENS (IOL). THE IOL WAS NOT UTILIZED DURING THE PROCEDURE. PATIENT PROGNOSIS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24231163 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S OPERATIVE EYE IN A SECONDARY SURGICAL PROCEDURE. THE REASON FOR EXPLANT WAS NOT SPECIFIED. THE EXPLANTED LENS WAS REPLACED (THE INFORMATION ABOUT THE REPLACEMENT LENS WAS NOT PROVIDED). THE PATIENT OUTCOME STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24050193 ↗
• InjuryDec 26, 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 IN A SECONDARY SURGICAL PROCEDURE DUE TO PATIENT'S DISSATISFACTION WITH VISION AND NIGHT VISION GLARE. THE ISSUE WAS NOTICED FOLLOWING IMPLANTATION DURING THE POST-OPERATIVE PERIOD. THE DIRECTIONS FOR USE WERE FOLLOWED. IT IS UNKNOWN IF THE ISSUE IMPACTED PATIENT'S DAILY ACTIVITY. THE REPLACEMENT IOL WAS OF A DIFFERENT MODEL AND DIOPTER (DIB00, +23.0D). THE PROCEDURE DID NOT REQUIRE ANY UNPLANNED INCISION ENLARGEMENT, VITRECTOMY OR SUTURES. IT IS UNKNOWN IF THERE WAS A DELAY IN PROCEDURE. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 23898765 ↗
• InjuryDec 10, 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 IMPLANTED INTO THE PATIENT¿S LEFT EYE. THE PATIENT EXPERIENCED POOR VISION DUE TO HALOS AND GLARE. THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT, SUTURES OR MEDICATION OUTSIDE OF THE STANDARD OF CARE. THE PATIENT WAS REPORTED AS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 23774905 ↗
• MalfunctionDec 9, 2025Break; Break

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS NOTED TO BE DAMAGED DURING THE INJECTION PROCESS. THE SURGEON ROTATED THE IMPLANTED LENS SO THE DEFECT WAS POSITIONED SUPERIORLY TO MITIGATE POTENTIAL CLINICAL IMPACT. THE PROCEDURE WAS COMPLETED WITHOUT INTERRUPTION AND THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764892 ↗
• InjuryDec 4, 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 PATIENT COMPLAINTS OF BLURRED VISION AND GLARE WITH BOTH READING AND DISTANCE VISION, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE; REPLACEMENT IOL INFORMATION IS UNKNOWN. THERE ARE NO DAILY ACTIVITIES THAT THE PATIENT CANNOT PERFORM THAT HE WAS ABLE TO PRIOR TO THE SURGERY. THERE WAS NO INCISION ENLARGEMENT, NO MEDICAL ATTENTION, NO MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), NO PROCEDURAL DELAYS, NO SUTURE(S), AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. BEST CORRECTED VISUAL ACUITY (BCVA) PRE-OPERATIVE WAS 20/40 AND POST OPERATIVE WAS 20/20. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23724053 ↗
• InjuryDec 4, 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 EXPERIENCED POOR COMPUTER AND READING VISION. THE PATIENT REPORTED AN INABILITY TO PERFORM NIGHTTIME DRIVING POST-SURGERY. THE ISSUE WAS IDENTIFIED DURING A POST-OPERATIVE EXAMINATION. THE PRE-OPERATIVE (PRE-OP) REFRACTION WAS 20/25-2 AND PRE-OP BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) WAS 20/20. THE INTENDED TARGET REFRACTION WAS -0.22. THE POST-OPERATIVE (POST-OP) REFRACTION AND BSCVA WITH THE ORIGINAL LENS WAS 20/20-1. THE PATIENT DID NOT EXPERIENCE A LOSS OF TWO OR MORE LINES OF BSCVA, AND THERE WAS NO OVER- OR UNDER-CORRECTION. NO PRE-EXISTING CONDITIONS AFFECTED THE CALCULATION. THE LENS WAS SUBSEQUENTLY EXPLANTED IN A SECONDARY SURGERY AND REPLACED WITH A NON-JOHNSON AND JOHNSON IOL WITH +21.0 DIOPTER. NO UNPLANNED INCISIONS, SUTURES, OR VITRECTOMY WERE PERFORMED. THERE WAS NO DELAY IN PROCEDURE AND DIRECTIONS FOR USE WERE FOLLOWED. THERE WAS NO PATIENT INJURY. THE PATIENT DID NOT NEED ADDITIONAL MEDICAL ATTENTION OR MEDICATION OUTSIDE THE STANDARD OF CARE. THE POST-OP REFRACTION AFTER THE LENS EXCHANGE WAS 20/20-1. THE PATIENT IS FULLY RECOVERED. PER T

  Patient problems: Blurred Vision

  MAUDE report 23723550 ↗
• InjuryNov 20, 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 IMPLANTED INTO THE PATIENT¿S RIGHT EYE. DURING A POST-OPERATIVE EXAM THE PATIENT REPORTED THAT THEIR COMPUTER VISION IS TERRIBLE AND THEIR READING IS NOT GOOD. THE IOL WAS EXPLANTED IN A SECONDARY SURGERY AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS MODEL EN+21.0. THE PATIENT¿S BEST CORRECTED VISUAL ACUITY (BCVA) PRE-OPERATIVELY WAS REPORTED AS 20/20 -1. POST-OPERATIVE BCVA WAS 20/20 -1. THE CUSTOMER INDICATED THAT THEY FOLLOWED THE DIRECTIONS FOR USE. THERE WAS NO UNPLANNED INCISION ENLARGEMENT, SUTURES VITRECTOMY OR DELAY IN THE PROCEDURE. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS REQUIRED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 23612963 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT INTRAOCULAR LENS EXCHANGE PROCEDURES FOR BOTH EYES WHICH WERE IMPLANTED WITH PRELOADED MULTIFOCAL INTRAOCULAR LENSES (IOLS). FOLLOWING THE INITIAL IMPLANTATION, POST-OPERATIVELY, THE PATIENT EXPERIENCED ISSUES WITH HALOS AND GLARE, LEADING TO NON-ADAPTATION. IT IS UNKNOWN WHETHER THESE SYMPTOMS AFFECTED THE PATIENT'S ACTIVITIES OF DAILY LIFE. THE REPLACEMENT LENSES USED IN BOTH EYES WERE NON-JOHNSON & JOHNSON IOLS, WITH A POWER OF +20.5 DIOPTERS. THERE WERE NO UNPLANNED VITRECTOMIES, INCISION ENLARGEMENTS, SUTURES, OR MEDICATIONS OUTSIDE THE STANDARD OF CARE REQUIRED. NO INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S INITIAL OUTCOME WAS DESCRIBED AS TEMPORARILY IMPAIRED, BUT THE CURRENT STATUS REMAINS UNKNOWN. PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY WAS 20/30-2 IN THE RIGHT EYE (OD) AND 20/20 IN THE LEFT EYE (OS). NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THIS EMDR REPORT PERTAINS TO THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 23087879 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT INTRAOCULAR LENS EXCHANGE PROCEDURES FOR BOTH EYES WHICH WERE IMPLANTED WITH PRELOADED MULTIFOCAL INTRAOCULAR LENSES (IOLS). FOLLOWING THE INITIAL IMPLANTATION, POST-OPERATIVELY, THE PATIENT EXPERIENCED ISSUES WITH HALOS AND GLARE, LEADING TO NON-ADAPTATION. IT IS UNKNOWN WHETHER THESE SYMPTOMS AFFECTED THE PATIENT'S ACTIVITIES OF DAILY LIFE. THE REPLACEMENT LENSES USED IN BOTH EYES WERE NON-JOHNSON & JOHNSON IOLS, WITH A POWER OF +20.5 DIOPTERS. THERE WERE NO UNPLANNED VITRECTOMIES, INCISION ENLARGEMENTS, SUTURES, OR MEDICATIONS OUTSIDE THE STANDARD OF CARE REQUIRED. NO INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S INITIAL OUTCOME WAS DESCRIBED AS TEMPORARILY IMPAIRED, BUT THE CURRENT STATUS REMAINS UNKNOWN. PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY WAS 20/30-2 IN THE RIGHT EYE (OD) AND 20/20 IN THE LEFT EYE (OS). NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THIS EMDR REPORT PERTAINS TO THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 23087690 ↗
• 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 SINISTER (LEFT 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 22960018 ↗
• InjurySep 2, 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 COMPLAINTS OF HALOS HOWEVER, IT IS UNKNOWN IF ISSUES WERE DEBILITATING. THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. BEST SPECTACLE CORRECTED VISUAL ACUITY (BCVA) PRE-OPERATIVE WAS 20/20 AND POST-OPERATIVE WAS 20/20. THERE WAS NO INCISION ENLARGEMENT, NO MEDICAL ATTENTION, NO MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), NO PROCEDURAL DELAYS, NO SUTURES, AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. BEST SPECTACLE CORRECTED VISUAL ACUITY (BCVA) PRE-OPERATIVE WAS 20/20 AND POST-OPERATIVE WAS 20/20. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo

  MAUDE report 22929701 ↗
• InjuryAug 29, 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 IN A SECONDARY SURGICAL PROCEDURE DUE TO THE PATIENT EXPERIENCING HALOS. THE ISSUE WAS IDENTIFIED DURING A POST-OPERATIVE EXAM. A NON-JOHNSON & JOHNSON LENS OF LOWER DIOPTER (20.0D) WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE AS A REPLACEMENT. NO UNPLANNED VITRECTOMY, SUTURES OR INCISION ENLARGEMENT REQUIRED AND NO DELAY IN PROCEDURE REPORTED. THERE WAS NO PATIENT INJURY OR ANY COMPLICATIONS SUCH AS CAPSULE TEAR REPORTED. NO MEDICAL ATTENTION WERE REQUIRED AND NO MEDICATIONS PRESCRIBED. BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) PRE-OPERATIVE: 20/20, BSCVA POST-OPERATIVE: 20/20. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 22926897 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DRN00V0210 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). DUE TO COMPLAINTS OF THE PATIENT WAS NOT ADAPTING TO LENS, NEAR VISION WAS NOT SATISFACTORY, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DXR00V +21.00 IOL. THERE WAS NO PATIENT INJURY DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS IMPROVING GREATLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 22688524 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HAPTICS OF THE PRELOADED LENS WAS EXPLANTED BECAUSE THE PATIENT WAS NOT SATISFIED WITH THEIR VISION, WHICH LED TO THE EXPLANT AND EXCHANGE. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH A DIB00 MODEL LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 22475532 ↗