TECNIS ODYSSEY IOL DRN00V (REF DRN00V0215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 05050474810792), received between Jan 11, 2024 and Sep 25, 2026 — classified as 26 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 25 most recent of 30 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 50902712 ↗
• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a lens exchange was performed in the right eye of a patient. The implanted preloaded multifocal intraocular lens (IOL) was explanted due to the patient's complaint of halos while driving at night, which significantly interfered with daily activities. The lens was exchanged with a DEN00V +20.5D IOL. The patient's pre-operative visual acuity was reported as 20/25, and the post-operative visual acuity was reported as 20/40 at one day post-operatively. No patient injury was reported. No medical or surgical interventions associated with the event were reported, and no future interventions were planned. The patient was reported to be doing well post-operatively following the lens exchange. The explanted lens was discarded and, therefore, is not available for evaluation. No further information was provided.

  Patient problems: Halo; Visual Impairment

  MAUDE report 50437548 ↗
• MalfunctionJul 21, 2026Scratched Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25893858 ↗
• 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 LEFT EYE. THE PATIENT EXPERIENCED BLURRY VISUAL ACUITY AND TROUBLE FOCUSING. THE IOL WAS EXPLANTED AND REPLACED WITH A NON- JOHNSON AND JOHNSON LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 25365506 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRN00V WAS EXPLANTED DUE TO PATIENT DISSATISFACTION RELATED TO GLARE AND HALOS. THE LENS WAS EXCHANGED FOR A PRELOADED MONOFOCAL IOL (MODEL DCB00). THE EXCHANGE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS; NO SUTURES OR VITRECTOMY WERE REQUIRED. THE COMPLAINT DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 25144448 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DISSATISFIED WITH THE VISUAL OUTCOME FOLLOWING IMPLANTATION OF A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRN00V, 21.0 D. THE PHYSICIAN SUBSEQUENTLY EXPLANTED THE LENS DURING A SECONDARY SURGICAL PROCEDURE AND IMPLANTED A REPLACEMENT LENS OF THE SAME MODEL WITH A 3.5-DIOPTER DIFFERENCE (DRN00V, 17.5 D). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 24981645 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S RIGHT EYE. THE PATIENT REPORTED EXPERIENCING VISUAL DISTURBANCES, SPECIFICALLY SEVERE HALOS OR RINGS AROUND LIGHTS, WHICH BEGAN IMMEDIATELY AFTER THE IMPLANT. SHE RAISED CONCERNS ABOUT DRIVING SAFETY AND NOTED THAT HER DOCTOR HAD INFORMED HER OF THE POTENTIAL FOR SUCH SYMPTOMS BUT HAD NOT ANTICIPATED THEIR SEVERITY. THE PATIENT CALLED BACK LATER TO REPORT THAT THE IOL WAS EXPLANTED BECAUSE SHE COULD NOT TOLERATE THE HALOS AND HAD DIFFICULTY DRIVING. JOHNSON AND JOHNSON FOLLOWED UP WITH THE DOCTOR¿S OFFICE. THE DOCTOR INVOLVED IS DR. (B)(6). THEY CONFIRMED THE IOL WAS EXPLANTED AND REPLACED WITH A NON JNJ MONOFOCAL LENS 21.5 DIOPTER. THE DOCTOR¿S OFFICE EXPLAINED THAT THE PATIENT WAS NOT A GOOD CANDIDATE FOR A MULTIFOCAL LENS TO BEGIN WITH, BUT THE PATIENT WAS ADAMANT ABOUT TRYING THEM. THE PATIENT EXPERIENCED HALOS AND NEVER NEURO ADAPTED. DURING THE ORIGINAL PROCEDURES AND THE EXPLANT THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, OR SUTURES. THE EXPLANTED IOL WAS LIKELY DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo

  MAUDE report 24677224 ↗
• InjuryFeb 6, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING IMPLANTATION OF A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRN00V, INTO THE PATIENT¿S RIGHT EYE, THE HAPTICS WERE STUCK TOGETHER, CAUSING THE LENS TO FLIP AND RESULTING IN A TEAR OF THE ANTERIOR CAPSULE. THE PATIENT BECAME VERY UPSET FOLLOWING THE EVENT. THE SURGEON SUBSEQUENTLY CUT THE IMPLANT FOR REMOVAL AND IMPLANTED THE BACKUP LENS DURING THE SAME PROCEDURE. AN ANTERIOR VITRECTOMY WAS ALSO REQUIRED AS PART OF THE ADDITIONAL SURGICAL MANEUVERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NON¿JOHNSON & JOHNSON REPLACEMENT LENS. REPORTEDLY PATIENT EXPERIENCED HUGE ANTERIOR CAPSULE TEAR. ADDITIONAL INTERVENTIONS INCLUDED AN ANTERIOR VITRECTOMY, INCISION ENLARGEMENT, AND PLACEMENT OF A SUTURE. MEDICATION OUTSIDE THE STANDARD OF CARE (MIOCHOL) WAS ADMINISTERED. THE CURRENT PATIENT OUTCOME IS UNKNOWN, AS THE REPORTER HAS NOT SPOKEN WITH THE SURGEON SINCE THE INCIDENT OCCURRED. THE COMPLAINT DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 24284818 ↗
• MalfunctionFeb 2, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE EYE AND SUBSEQUENTLY SPLIT IN HALF/TORE DURING THE IMPLANTATION PROCESS. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS WITHOUT COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242516 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED LIKELY DUE TO REFRACTIVE MISS. THE EXPLANTED IOL WAS REPLACED WITH AN ALCON PANOPTIX 23.0. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 24223613 ↗
• InjuryJan 16, 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 RIGHT EYE AS THE PATIENT REPORTED OF EXPERIENCING VISUAL ISSUES, INCLUDING A FILM OVER VISION AND VERY BLURRY SIGHT. THE ISSUE WAS NOTED DURING THE POST-OPERATIVE VISIT. IT IS UNKNOWN IF THE SYMPTOMS IMPACTED PATIENT'S DAILY ACTIVITIES PRIOR TO THE EXPLANT. A NON-JOHNSON & JOHNSON LENS OF A LOWER DIOPTER (+21.0D) WAS USED AS THE REPLACEMENT. THE PRE AND POST-OPERATIVE BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) WERE 20/20-2 AND 20/25-1 RESPECTIVELY. THERE WAS NO SURGICAL DELAY IN PROCEDURE AND NO COMPLICATIONS, SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY REPORTED DURING THE EXPLANT PROCEDURE. NO MEDICAL ATTENTION OR MEDICATION OUTSIDE OF THE STANDARD OF CARE WAS REQUIRED. THE PATIENT HAS FULLY RECOVERED. DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 24103634 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FULLY IMPLANTED PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS SCHEDULED TO BE EXCHANGED FOR A DIFFERENT LENS FROM THE LEFT EYE DUE TO THE PATIENT HAVING MORE CYLINDER THAN INITIALLY PREDICTED. THERE WERE NO SUSPECTED PROBLEMS WITH THE LENS. ADDITIONAL INFORMATION WAS RECEIVED WHICH CONFIRMED THAT THE EXPLANT SURGERY WAS COMPLETED. THE REPLACEMENT LENS IS UNKNOWN. IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS FROM THE EXCHANGE. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 23916929 ↗
• InjuryDec 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 DEXTER (RIGHT EYE). THE PATIENT REPORTED COMPLAINTS OF GLARE AND HALOS, THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A ZCB00 21.5 DIOPTER IOL. DURING THE LENS EXCHANGE PROCEDURE, THERE WAS NO INCISION ENLARGEMENT, SERIOUS PATIENT INJURY, SUTURES, NOR VITRECTOMY. PATIENT PROGNOSIS AND VISUAL ACUITY POST-LENS EXCHANGE ARE BOTH UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 23804439 ↗
• InjuryDec 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 FULLY IMPLANTED IN THE PATIENT¿S LEFT EYE, A REFRACTIVE ERROR WAS IDENTIFIED AT A POST-OPERATIVE EXAMINATION. THE LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY. THERE WAS NO IMPACT ON THE PATIENT¿S DAILY ACTIVITIES. NO UNPLANNED INCISION ENLARGEMENT, SUTURES, VITRECTOMY, OR PROCEDURAL DELAYS OCCURRED, AND NO ADDITIONAL MEDICAL TREATMENT OR MEDICATIONS BEYOND STANDARD OF CARE WERE REQUIRED. THE PATIENT EXPERIENCED TEMPORARY SYMPTOMS BUT RETAINED A BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) OF 20/20 BOTH PRE-OPERATIVELY AND POST-OPERATIVELY. DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 23791332 ↗
• InjuryDec 9, 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 FROM THE LEFT EYE (OS) DUE TO THE PATIENT¿S INABILITY TO ADAPT TO THE IOL POWER, WHICH AFFECTED THE PATIENT'S LIFE AND CAUSED DIFFICULTY WITH NEAR VISION AND THE INABILITY TO READ WITHOUT ADDITIONAL CORRECTION. IT WAS REPORTED THAT THERE WAS A LOSS OF TWO OR MORE LINES OF BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) FOR NEAR ACUITY. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT; SAME MODEL, DIFFERENT DIOPTER OF 22.5. NO UNPLANNED SURGICAL INTERVENTIONS WERE REQUIRED AND NO MEDICATIONS OUTSIDE THE STANDARD OF CARE WERE PRESCRIBED. THE PATIENT¿S PRE-OPERATIVE (PRE-OP) REFRACTION WAS -0.50 -0.50 X 152 AND BSCVA OF 20/20. THE PATIENT¿S POST-OPERATIVE (POST-OP) REFRACTION WAS +0.75 -0.50 X 150 AND BSCVA OF 20/20. THE INTENDED TARGET REFRACTION WAS +1.00. THE PATIENT¿S POST-OP REFRACTION FOLLOWING THE LENS EXCHANGE WAS 20/40 OS AND 20/20 OU (BOTH EYES) ON DAY ONE POST-OP. THE PATIENT DID NOT HAVE ANY PRE-EXISTING CONDITIONS THAT AFFECTED CALCULATION. THE PATIENT WAS NOT OVER CORRECTION OR UNDER CORRECTION. THE OUTCOME OF THE PATIENT WAS REPORTED AS SUCCESSFUL. THE PATIENT IS SCHEDULED TO R

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23761041 ↗
• 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 RIGHT EYE DUE TO AN UNKNOWN REASON. THE REPLACEMENT LENS IS THE SAME JOHNSON AND JOHNSON IOL MODEL, DRN00V 20.0 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 23330366 ↗
• 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 DUE TO THE PATIENT EXPERIENCING DYSPHOTOPSIA. THE REPLACEMENT LENS IS A NON-JOHNSON AND JOHNSON MODEL, PANOPTIX IOL. PATIENT-SPECIFIC DETAILS, INCLUDING DATE OF BIRTH, WEIGHT, SEX, GENDER, RACE, AND ETHNICITY, WERE NOT PROVIDED DUE TO PRIVACY CONCERNS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 23328255 ↗
• MalfunctionSep 15, 2025Crack; Mechanical Jam; Crack; Mechanical Jam

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PRELOADED MULTIFOCAL INTRAOCULAR LENS (DRN00V). THE LENS FAILED TO ADVANCE DURING LOADING, CAUSING IT TO FOLD AND SPLIT THE CARTRIDGE, CARTRIDGE TIP HAD PATIENT CONTACT. THE EVENT OCCURRED WHILE INSERTING THE LENS INTO THE EYE. ANOTHER JOHNSON & JOHNSON LENS OF THE SAME MODEL AND DIOPTER WAS SUCCESSFULLY IMPLANTED. THERE WAS NO PATIENT INJURY, AND NO SURGICAL OR MEDICAL INTERVENTIONS WERE REQUIRED. THE PATIENT IS DOING FINE POST-OPERATION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059006 ↗
• InjurySep 9, 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 A REFRACTIVE MISS, AND ANOTHER ODYSSEY IOL WAS SUCCESSFULLY IMPLANTED. THE MODEL AND DIOPTER OF THE REPLACEMENT LENS ARE UNKNOWN. NO MEDICAL OR SURGICAL INTERVENTIONS, SUCH AS VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT, WERE REQUIRED. THE PATIENT IS REPORTED TO BE WELL FOLLOWING THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 23000520 ↗
• 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. 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 +20.5. 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.

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

  MAUDE report 22989590 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS UNABLE TO ADAPT TO THE IMPLANTED INTRAOCULAR LENS (IOL), MODEL DIB00 +21.5. THE LENS WAS INSERTED ON (B)(6) 2025, AND SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY, WITH ANOTHER INTRAOCULAR LENS OF THE SAME MODEL, DIB00 +21.5, IMPLANTED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 22874920 ↗
• InjuryJul 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO SEVERE HALOS AT NIGHT. IT WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH ANOTHER COMPANY¿S IOL. NO INJURY OR INTERVENTION WAS REQUIRED. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo

  MAUDE report 22552194 ↗
• InjuryJul 4, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE DOCTOR THAT A CRACK WAS DISCOVERED IN THE LENS IN THE PATIENT'S EYE. THE PATIENT RETURNED COMPLAINING OF POOR VISION, AND THE CRACK WAS IDENTIFIED UPON REEXAMINATION. THE CRACK HAD NOT BEEN SEEN BY THE IMPLANTING DOCTOR DUE TO LEFTOVER CORTEX AND LENS FRAGMENTS. THE PATIENT THEN CONSULTED A DIFFERENT DOCTOR, WHO REQUESTED AN EXPLANT. DURING THE EXPLANT PROCEDURE, DUE TO THE PATIENT'S ANATOMY, THE LENS BECAME CAUGHT IN THE CAPSULE, RESULTING IN A CAPSULAR TEAR. THIS COMPLICATION NECESSITATED THE IMPLANTATION OF A 3-PIECE LENS SUTURED INTO THE SULCUS. THE LENS WAS SUBSEQUENTLY REMOVED AND REPLACED WITH ANOTHER COMPANY'S IOL DURING A SECONDARY SURGICAL PROCEDURE. THE PATIENT REQUIRED INCISION ENLARGEMENT, VITRECTOMY, AND SUTURES. THE PATIENT'S OUTCOME WAS AS FOLLOWS: NO EDEMA, VISUAL ACUITY OF 21/25, INTRAOCULAR PRESSURE (IOP) OF 8 MMHG, AND MILD VITREOUS HEMORRHAGE. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 22406810 ↗
• InjuryJul 3, 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) IMPLANTED IN THE LEFT EYE WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO PATIENT EXPERIENCING SEVERE HALOS DESPITE HAVING EXCELLENT VISION. THE PATIENT WAS UNABLE TO TOLERATE SEEING HALOS. THEREFORE, ANOTHER LENS OF A DIFFERENT MODEL (DIB00) WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 22400883 ↗
• 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, PATIENT IOL'S 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 LEFT EYE. OTHER REPORT IS BEING SUBMITTED FOR PATIENT'S RIGHT EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 21869164 ↗