TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 05050474811379), received between Dec 26, 2024 and Jul 27, 2026 — classified as 17 injuries, 2 malfunctions.

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a female patient experienced visual issues following bilateral implantation of multifocal Toric intraocular lenses (IOLs). The patient reported noticing vision changes in both eyes almost immediately after surgery. The primary complaint was impaired distance vision, including difficulty seeing highway signs and other distant objects. The patient described her vision as blurry and unfocused and stated that the symptoms had progressively worsened. She further described her vision as feeling as though a protective covering had been left on the lenses.The procedures were completed successfully. The patient discussed her concerns with the physician and was advised to allow additional time for recovery; however, the symptoms reportedly persisted. The patient indicated a desire to have the lenses explanted and replaced with lenses that would better meet her visual needs.The patient further reported that difficulty seeing distant objects had significantly impacted her daily activities. She stated that driving had become hazardous because she could not read road signs until she was very close to them. She also reported frequent squinting to see at a distance, resulting

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

  MAUDE report 50037216 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRT150, WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. POSTOPERATIVELY, THE PATIENT INITIALLY REPORTED SATISFACTORY VISION; HOWEVER, THEY SUBSEQUENTLY EXPERIENCED BOTHERSOME HALOS AND DIFFICULTY READING MATERIALS WITH DARK BACKGROUNDS. ADDITIONAL INFORMATION INDICATED THAT THE LENS RING DESIGN CONTRIBUTED TO THE HALOS AND ASSOCIATED VISUAL DISTURBANCES. AS A RESULT OF THESE SYMPTOMS, THE IOL WAS EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DIFFERENT MODEL AND DIOPTER (ZCU150U210). FURTHER INFORMATION INDICATED THAT THE PATIENT¿S ACTIVITIES OF DAILY LIVING WERE NOT IMPACTED. THE PATIENT WAS NEITHER OVERCORRECTED NOR UNDERCORRECTED. PREOPERATIVE REFRACTION WAS +2.00 -1.25 × 091, AND POSTOPERATIVE REFRACTION FOLLOWING THE INITIAL IMPLANTATION WAS +0.50 -0.50 × 175, WITH AN INTENDED REFRACTIVE TARGET OF PLANO. BEST SPECTACLE-CORRECTED VISUAL ACUITY (BSCVA) CHANGED FROM 20/15 PREOPERATIVELY TO 20/20 POSTOPERATIVELY FOLLOWING THE INITIAL PROCEDURE. AFTER THE LENS EXCHANGE, POSTOPERATIVE REFRACTION WAS -0.25 SPHERE. THERE WERE NO REPORTS OF UNPLANNED SURGICAL INTERVENTIONS (E.G., VITRECTOMY, INCISI

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 25429230 ↗
• MalfunctionJun 1, 2026Device Difficult to Setup or Prepare; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRT150, INTO THE PATIENT¿S RIGHT EYE, RESISTANCE WAS ENCOUNTERED DURING LENS ADVANCEMENT, RESULTING IN THE LENS TEARING. PATIENT CONTACT OCCURRED. ADDITIONAL INFORMATION CONFIRMED THAT THE LENS WAS PARTIALLY DELIVERED, AND NO ADDITIONAL SURGICAL MANEUVERS BEYOND STANDARD TECHNIQUE WERE REQUIRED TO FACILITATE LENS DELIVERY AND POSITIONING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER. NO PATIENT INJURY WAS REPORTED, AND NO UNPLANNED MEDICAL OR SURGICAL INTERVENTIONS (SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR SUTURING) WERE REQUIRED. THE CURRENT PATIENT OUTCOME IS REPORTED AS DOING WELL. THE STABLEVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WAS USED TO FILL THE CARTRIDGE PRIOR TO LENS LOADING AT ROOM TEMPERATURE. THE CARTRIDGE WAS PREPARED WITH BALANCED SALT SOLUTION (BSS) OR OVD VIA THE HYDRATION PORT. ONE TWIST OF THE INJECTOR KNOB WAS PERFORMED TO ADVANCE THE LENS INTO THE CARTRIDGE, AND AN ADDITIONAL TWIST WAS COMPLETED PRIOR TO HANDING THE HANDPIECE TO THE SURGEON. THE LENS REMAINED IN THE CARTRIDGE FOR NO LONGER THAN TWO MINUTES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25356476 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  THE DRT150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DUE TO COMPLAINTS OF PATIENT DISSATISFACTION, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A ZCU150 22.0 IOL. THERE WAS NO INCISION ENLARGEMENT AND NO SERIOUS PATIENT INJURY DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXPLANT IS UNKNOWN. THE SUSPECT IOL IS NOT AVAILABLE FOR INVESTIGATION AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 24285129 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD REFRACTIVE LENS EXCHANGE (RLE) IN LEFT EYE. THE DIRECTIONS FOR USE WERE FOLLOWED. PATIENT PRESENTED POST OP WITH POOR TOLERANCE OF THE MULTIFOCAL LENS AND IT WAS IDENTIFIED THAT PATIENT WAS UNDER-CORRECTED. NO UNPLANNED INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES WERE REQUIRED. THERE WAS NO DELAY IN THE PROCEDURE AND NO MEDICATION OUTSIDE OF STANDARD CARE. THE PATIENT¿S STATUS IS TEMPORARILY IMPAIRED. PATIENT PREOPERATIVELY BEST CORRECTED VISUAL ACUITY (BCVA) FOR BOTH EYES: 20/20 REFRACTION: +0.75 -1.75 × 49. POST-OPERATIVELY: 20/63 BCVA THE REPLACEMENT LENSES WERE JOHNSON & JOHNSON LENS: DIU150 +23.0 THE INTENDED TARGET REFRACTION WAS PLANO.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 24284531 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  THE DRT150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING HALOS AT NIGHT THAT AFFECTED HER ABILITY TO DRIVE. THE PATIENT'S BEST CORRECTED VISUAL ACUITY REMAINED 20/20 BOTH PRE AND POST OPERATIVELY. THE IOL WAS EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON LENS, ENT200 20.5 IOL. 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. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. PATIENT PROGNOSIS POST IOL EXPLANT WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo

  MAUDE report 24042433 ↗
• 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 TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE, THE PATIENT REPORTED VISUAL ISSUES THAT AFFECTED DAILY ACTIVITIES, INCLUDING READING AND DRIVING. THE ISSUE WAS IDENTIFIED DURING THE POST-OPERATIVE EXAMINATION. THE LENS WAS SUBSEQUENTLY EXPLANTED IN A SECONDARY SURGERY. NO UNPLANNED VITRECTOMY OR ADDITIONAL MEDICAL ATTENTION OR MEDICATION OUTSIDE THE STANDARD OF CARE WAS REQUIRED. IT IS UNKNOWN IF INCISION ENLARGEMENT WAS REQUIRED. THE PATIENT'S DISTANCE VISUAL ACUITY WITHOUT CORRECTION (DSC) IMPROVED FROM 20/40 PRE-OPERATIVELY TO 20/30 POST-OPERATIVELY. THE PATIENT OUTCOME IS UNKNOWN. THE DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 23597925 ↗
• InjuryNov 6, 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 RIGHT PATIENT¿S EYE. THE PATIENT EXPERIENCED GLARE AND HALOS THAT SIGNIFICANTLY AFFECTED THEIR DAILY ACTIVITIES AND EXPRESSED A DESIRE TO TRY A LENS WITH LESS GLARE. THE IOL WAS EXPLANTED THE REPLACEMENT LENS IS UNKNOWN. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY. THE MEDICATION PRESCRIBE WAS WITHIN THE STANDARD OF CARE. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 23493535 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN UNCOMPLICATED CATARACT SURGERY IN WHICH THE PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE, THE PATIENT EXPERIENCED DRY EYE WHICH WOULD NOT RESOLVE WITH EYE DROPS OR EYE OINTMENT (WHICH WERE STANDARD OF CARE). THE PATIENT ALSO EXPERIENCED PERSISTENT HEADACHE AND PAIN WHILE READING. IT WAS NOTED THAT DAILY ACTIVITIES WERE AFFECTED BY THE PATIENT¿S SYMPTOMS. THE PATIENT SOUGHT A SECOND REFERRAL AND DECIDED TO PROCEED WITH AN IOL EXCHANGE IN THE LEFT EYE. THE REPLACEMENT LENS IS UNKNOWN. IT IS UNKNOWN IF THE ANY MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Dry Eye(s); Eye Pain; Headache

  MAUDE report 23441919 ↗
• 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 TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT¿S COMPLAINTS OF GLARE AND HALOS. THE LENS WAS REPLACED WITH ANOTHER JOHNSON & JOHNSON IOL; DCB00 21.5 DIOPTER. IT IS UNKNOWN IF ANY MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 23418736 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DISSATISFIED WITH THEIR BEST CORRECTED VISUAL ACUITY (BCVA) AFTER RECEIVING A PRELOADED TORIC INTRAOCULAR LENS. THEY EXPERIENCED A HYPEROPIC SURPRISE, DESPITE THE SURGEON CONFIRMING THAT ALL MEASUREMENTS AND CALCULATIONS WERE ACCURATE. THEIR MANIFEST REFRACTION (MRX) WAS +2.50 SPH, AND THEIR SIGNIFICANT DRY EYE CONDITION, WHICH HAD BEEN TREATED AND STABILIZED OVER SIX MONTHS, SHOWED NO CHANGE IN MEASUREMENTS. DUE TO THE UNEXPECTED HYPEROPIA AND LACK OF A CLEAR EXPLANATION, A DECISION WAS MADE TO TARGET APPROXIMATELY -2.50 DIOPTERS FOR FUTURE CORRECTION. THE INITIAL LENS WAS EXPLANTED AND REPLACED WITH ANOTHER PRELOADED TORIC LENS OF 25 DIOPTERS. SINCE THE LENS EXCHANGE, THE PATIENT'S VISION HAS IMPROVED SIGNIFICANTLY, AND THEY HAVE EXPRESSED MUCH GREATER SATISFACTION. THEIR CURRENT REFRACTION IS NOW -2.25 SE, SUGGESTING THERE MAY HAVE BEEN AN ABNORMALITY WITH THE INITIALLY DELIVERED LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dry Eye(s); Visual Impairment

  MAUDE report 22578106 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LENS EXCHANGE OCCURRED WITH A PRELOADED INTRAOCULAR LENS (IOL) WITH MODEL DRT150 DUE TO AN UNKNOWN ISSUE. THE ISSUE WAS FIRST IDENTIFIED DURING A POST-OPERATIVE EXAM. THE LENS WAS REMOVED DURING A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH AN UNKNOWN IOL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 22414229 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PLANNED EXPLANT OF AN INTRAOCULAR LENS (IOL) DUE TO ANISOMETROPIA WAS REPORTED. AT A LATER DATE, INFORMATION WAS RECEIVED THAT THE LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO REFRACTIVE MISS. A REPLACEMENT IOL OF DIFFERENT MODEL AND HIGHER DIOPTER (DRN 22.0D) WAS USED. THERE WERE NO REPORTED COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 22399319 ↗
• MalfunctionJul 1, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE PRELOADED TORIC INTRAOCULAR LENS DID NOT UNFOLD CORRECTLY IN THE PATIENT'S EYE. ADDITIONAL INFORMATION INDICATED THAT THE LENS WAS REMOVED AND REPLACED WITH A NEW LENS. THE PATIENT EXPERIENCED CORNEAL EDEMA ON POSTOPERATIVE DAY 1 BUT SHOWED IMPROVEMENT BY ONE WEEK POSTOPERATIVELY. THE PATIENT'S CURRENT VISION IS 20/20. THERE WERE NO REPORTS OF PATIENT INJURY OR USER ERROR, AND NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379151 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTING THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED ¿UNACCEPTABLE VISION QUALITY.¿ THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND THE REPLACEMENT LENS IS UNKNOWN. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22290714 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WHO RECEIVED A TORIC INTRAOCULAR LENS (IOL) IMPLANT IN HIS LEFT EYE REPORTED DISSATISFACTION, INDICATING THAT HIS VISION HAS NOT IMPROVED AND IS WORSE THAN BEFORE THE IMPLANT. THE PATIENT'S EXPECTATION WAS THAT HIS REACHING DISTANCE, AND MID-RANGE VISION WOULD BE BETTER. THE PATIENT STATED THAT BEFORE SURGERY, HIS LEFT EYE WAS 20/50- AND ONE-DAY POST IMPLANT, HE WAS TOLD TO BE 20/25, BUT THE PATIENT DOES NOT BELIEVE THAT. A PLANNED EXPLANT PROCEDURE WAS SCHEDULED. AT A LATER DATE INFORMATION WAS RECEIVED FROM THE DOCTOR WHO REPORTED THAT THE LENS WAS EXPLANTED AND REPLACED WITH A MONOFOCAL IOL. THE EXPLANT PROCEDURE WAS CARRIED OUT WITHOUT ANY COMPLICATIONS, AND THE DOCTOR CONFIRMED THAT EVERYTHING PROCEEDED AS EXPECTED WITHOUT THE NEED FOR SUTURES. DUE TO THE PATIENT'S UNDERLYING RETINAL PROBLEMS, THE DOCTOR ANTICIPATED THAT THE PATIENT WOULD NOT EXPERIENCE IMPROVED DISTANCE VISION WITH THE MONOFOCAL IOL. ON (B)(6) 2025, THE PATIENT COMMUNICATED TO THE DOCTOR THAT, THERE WAS NO IMPROVEMENT IN HIS VISION. THE LENS IS NOT COMING BACK AS THE ACCOUNT DID NOT SAVE IT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Discomfort; Halo

  MAUDE report 22172650 ↗
• InjuryMay 16, 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 BLURRY VISION AT BOTH NEAR AND DISTANCE. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH A NON-J&J LENS. THERE WAS NO INJURY AND NO FURTHER INTERVENTION WAS REQUIRED. THE PATIENT FULLY RECOVERED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 22038412 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR IDENTIFIED A HYPEROPIC RESULT OF +1.50 FOR A PATIENT AND THE LENS WAS EXPLANTED. DOCTOR REPLACED THAT LENS WITH A DRT150 22.0 DUE TO A MECHANICAL COMPLICATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 21146156 ↗
• InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BOTHERED BY GLARE AND HALO/CIRCLES AFTER IMPLANTATION OF PRELOADED INTRAOCULAR LENS(IOL). THE PATIENT ALSO HAD 20/32 FOR DISTANCE VISION. THE SURGEON DETERMINED THAT THE PATIENT WAS -0.75 D SO THE SUGGESTED THE PATIENT TO WEAR CONTACT LENSES FOR A FEW DAYS TO SEE IF THAT MADE THINGS BETTER. APPARENTLY THE PATIENT CONFIRMED THINGS WERE MUCH BETTER. AS A RESULT, THE SURGEON HAD PLANNED TO EXCHANGE THE PATIENT'S CURRENT LENS FOR A DIFFERENT MODEL. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 21021173 ↗