TECNIS ODYSSEY IOL DRN00V (REF DRN00V0195)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS ODYSSEY SIMPLICITY 19.5D · Class 3 · Implant
All models of TECNIS ODYSSEY IOL (49)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This TECNIS Odyssey multifocal intraocular lens is a preloaded implant lens placed in the eye during cataract surgery to restore vision. The 29 reports mostly describe the lens optic cracking, tearing or breaking after implantation, sometimes leaving a fragment floating in the eye, along with scratches and difficulty loading it into the inserter; many patients reported halos, glare, blurred or reduced vision. 18 reports describe injuries, no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 05050474810754), received between Nov 27, 2024 and Apr 17, 2026 — classified as 18 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Break” (6 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem18
- Break6
- Scratched Material3
- Ejection Problem2
- Material Fragmentation2
- Device Difficult to Setup or Prepare1
- Difficult to Fold, Unfold or Collapse1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Visual Disturbances8
- Halo5
- Eye Injury4
- Visual Impairment4
- Blurred Vision3
- Dry Eye(s)2
- Corneal Abrasion1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2026Break; Material Fragmentation
IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) OPTIC BROKE, AND A FRAGMENT WAS OBSERVED FLOATING IN THE EYE FOLLOWING IMPLANTATION OR APPLICATION. IT WAS STATED THAT THAT THEY ARE UNABLE TO RETURN THE PRODUCT FOR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED. THE ISSUE WAS REPORTED WITH TWO LENSES. THIS REPORT IS TWO OUT OF TWO. A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912892 ↗MalfunctionApr 17, 2026Break; Material Fragmentation
IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) OPTIC BROKE, AND A FRAGMENT WAS OBSERVED FLOATING IN THE EYE FOLLOWING IMPLANTATION OR APPLICATION. IT WAS STATED THAT THAT THEY ARE UNABLE TO RETURN THE PRODUCT FOR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED. THE ISSUE WAS REPORTED WITH TWO LENSES. THIS REPORT IS ONE OUT OF TWO. A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912871 ↗InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE DUE TO AN UNKNOWN REASON. THE REPLACEMENT LENS WAS ANOTHER JOHNSON AND JOHNSON (DRN00V 18.5). THE DOUVISC WAS USED AS VISCOELASTIC. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Eye Injury
MAUDE report 24793511 ↗InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO THE PATIENT¿S INABILITY TO ADAPT TO THE LENS. THE EXPLANTED LENS WAS REPLACED WITH A NON¿JOHNSON & JOHNSON IOL. NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR PRESCRIBED MEDICATIONS WERE REPORTED. NO PATIENT INJURY, INCLUDING CAPSULE TEAR, WAS NOTED. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT UNDERWENT BILATERAL LENS IMPLANTATION. THIS REPORT PERTAINS TO THE RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.
Patient problems: Visual Disturbances
MAUDE report 24477558 ↗MalfunctionJan 28, 2026Material Split, Cut or Torn; Ejection Problem
THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS PARTIALLY SEPARATED FROM THE INSERTER AND HAD A RIP, THUS MAKING IT UNSUITABLE FOR IMPLANTATION. PATIENT CONTACT WAS CONFIRMED HOWEVER, EXTENT IS UNKNOWN. PATIENT PROGNOSIS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24203386 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED BY THE CUSTOMER THAT AFTER IMPLANTATION, CRACKS OR TEARS WERE OBSERVED ON TWO SEPARATE PRELOADED MULTIFOCAL INTRAOCULAR LENSES (IOLS), MODEL DRN00V. BOTH LENSES WERE EXPLANTED AND REPLACED WITH SAME MODEL AND DIOPTER (DRN00V) LENS, WHICH SHOWED NO SIGNS OF SCRATCH. THE ORIGINAL LENSES WERE DISCARDED; HOWEVER, THE CUSTOMER PROVIDED AN ATTACHED WHITEBOARD ILLUSTRATION TO REPRESENT WHAT HE NOTICED ON THE OPTIC. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES ONE LENS. ANOTHER REPORT WILL CAPTURE THE OTHER LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24072553 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED BY THE CUSTOMER REPORTED THAT AFTER IMPLANTATION, CRACKS OR TEARS WERE OBSERVED ON TWO SEPARATE PRELOADED MULTIFOCAL INTRAOCULAR LENSES (IOLS), MODEL DRN00V. BOTH LENSES WERE EXPLANTED AND REPLACED WITH A THIRD LENS OF THE SAME MODEL AND DIOPTER (DRN00V), WHICH SHOWED NO SIGNS OF SCRATCH. THE ORIGINAL LENSES WERE DISCARDED; HOWEVER, THE CUSTOMER PROVIDED AN ATTACHED WHITEBOARD ILLUSTRATION TO REPRESENT WHAT HE NOTICED ON THE OPTIC. THIS REPORT CAPTURES ONE LENS. ANOTHER REPORT WILL CAPTURE THE OTHER LENS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24072533 ↗MalfunctionDec 29, 2025Break; Break
IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND WAS NOT IMPLANTED. IT IS UNKNOWN IF THERE WAS ANY PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23907565 ↗InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A MALE PATIENT REPORTED THAT HE HAD ODYSSEY LENSES IMPLANTED APPROXIMATELY SIX MONTHS AGO AND IS DISSATISFIED. HE IS UNABLE TO SEE SMALL ITEMS SUCH AS HIS CELL PHONE OR COMPUTER SCREEN AND CANNOT READ THE NEWSPAPER. THE PATIENT NOTED THAT, ALTHOUGH HE EXPERIENCED GLARE BEFORE SURGERY, NIGHT DRIVING IS NOW IMPOSSIBLE. HE BECOMES NEARLY SNOW-BLIND AND DEVELOPS A BRIGHT, BLINDING SPOT THAT CAN OBSCURE VISION FOR UP TO FIVE MINUTES. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENS IMPLANTATION. THIS REPORT IS FOR THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE.
Patient problems: Dry Eye(s); Visual Disturbances; Visual Impairment
MAUDE report 23899931 ↗InjuryDec 18, 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 EYE PAIN PROMPTING A VISIT TO THE EMERGENCY ROOM, WHERE A SCRATCHED CORNEA WAS SUSPECTED, ALTHOUGH NO OPHTHALMOLOGIST WAS AVAILABLE TO CONFIRM THIS. SHE HAD BEEN PRESCRIBED KETOROLAC, AN ANTI-INFLAMMATORY DRUG, BUT DISCONTINUED ITS USE ON HER REGULAR DOCTOR'S ADVICE DUE TO A SUSPECTED ALLERGIC REACTION, WHICH RESULTED IN SYMPTOM IMPROVEMENT. PATIENT HAS DRY EYE AND WAS INFORMED IT WAS A SIDE EFFECT AND TAKES EYE DROPS, SHE ALSO TAKES GABAPENTIN FOR OSTEOARTHRITIS. HER OPHTHALMOLOGIST CONFIRMED THE LENSES ARE PLACED CORRECTLY AND IT MAY TAKE 3-6 MONTHS FOR HER BRAIN TO ACCEPT THE LENSES. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Corneal Abrasion; Dry Eye(s)
MAUDE report 23846874 ↗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 DEXTER (RIGHT EYE). DUE TO COMPLAINTS OF DYSPHOTOPSIA, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON IOL, BAUSCH + LOMB. THERE WAS NO MEDICAL INTERVENTION, NO PATIENT INJURY, AND NO SURGICAL INTERVENTION DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS GOOD. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Disturbances
MAUDE report 23733549 ↗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 COMPLAINTS OF UNEXPECTED MYOPIA AND ASTIGMATISM, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRT300 18.5 IOL. THERE WAS NO MEDICAL INTERVENTION DURING THE EXPLANT PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS FINE. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 23719869 ↗MalfunctionNov 20, 2025Break; Break
IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS ¿DEFECTIVE¿ WHICH WAS IDENTIFIED DURING IMPLANTATION. NO INFORMATION WAS PROVIDED REGARDING HOW THE LENS WAS DEFECTIVE. IT WAS NOTED THAT THERE WAS NO PATIENT INVOLVEMENT AND THAT THE PATIENT¿S DAILY ACTIVITIES WERE STILL ABLE TO BE PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23606127 ↗InjuryNov 19, 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 PATIENT¿S RIGHT EYE. DURING A POST-OPERATIVE VISIT THE PATIENT REPORTED DYSPHOTOPSIA OF HALOS AND GLARE. PRE-OPERATIVE VISION WAS 20/40 AND POST-OPERATIVE VISION IS 20/40. THE IOL WAS EXPLANTED AND REPLACED IN A SECONDARY SURGERY. THE REPLACEMENT LENS INFORMATION WAS NOT PROVIDED. THERE WAS NO INCISION ENLARGEMENT, SUTURES OR VITRECTOMY REQUIRED. NO MEDICATION PRESCRIBED MEDICATION. THE PATIENT OUTCOME WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Halo; Visual Disturbances
MAUDE report 23601381 ↗InjuryNov 10, 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 DUE TO PATIENT'S INABILITY TO SEE MIDRANGE AND BEING BOTHERED BY THE HALOS WHILE DRIVING. THE ISSUES WERE IDENTIFIED DURING A POST-OPERATIVE EXAMINATION. THE PROCEDURE WAS COMPLETED USING A NON-JOHNSON & JOHNSON LENS OF 19.5 DIOPTER AS A REPLACEMENT WITHOUT ANY UNPLANNED COMPLICATIONS, SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY. THERE WAS NO SURGICAL DELAY. NO MEDICAL ATTENTION OR MEDICATION OUTSIDE OF THE STANDARD OF CARE WAS REQUIRED. DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT¿S BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) WAS 20/20 PRE AND POST-OPERATIVELY. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Halo; Visual Impairment
MAUDE report 23514491 ↗InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT DUE TO AN UNKNOWN REASON. PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Eye Injury
MAUDE report 23490042 ↗InjuryNov 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 UNKNOWN REASONS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRN00V 18.0 DIOPTER IOL. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Eye Injury
MAUDE report 23478912 ↗InjuryOct 23, 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 LENSES (IOL) WERE IMPLANTED IN BOTH EYES DURING CATARACT SURGERY, THE PATIENT WAS NOT HAPPY WITH THE LENSES AND EXPERIENCED BLURRINESS. THE PATIENT, WHO WORKS AS AN ELECTRICIAN, REPORTED DIFFICULTY SEEING WIRES UP CLOSE, WHICH HAS AFFECTED DAILY ACTIVITIES. THE PATIENT WAS ASSESSED AS UNDER-CORRECTED WITH NO LOSS OF TWO OR MORE LINES OF BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA). PRE-OPERATIVE REFRACTION WAS -2.00 -0.50 X 155 WITH A BSCVA OF 20/20-2, WHILE POST-OPERATIVE REFRACTION WAS -0.25 D.S. WITH A BSCVA OF 20/30. THE INTENDED TARGET REFRACTION WAS PLANO. A HISTORY OF LASER-ASSISTED INTRASTROMAL KERATOMILEUSIS (LASIK) WAS NOTED AS A PRE-EXISTING CONDITION THAT INFLUENCED THE LENS CALCULATION. THERE WAS NO INJURY REPORTED. THE SURGEON HAS DECIDED TO PERFORM A LENS EXCHANGE, THOUGH THE PROCEDURE HAS NOT YET BEEN SCHEDULED. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO CAPTURE THE RIGHT EYE EVENT. A SEPARATE REPORT WILL BE SUBMITTED TO CAPTURE THE LEFT EYE EVENT.
Patient problems: Blurred Vision
MAUDE report 23372218 ↗InjuryOct 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH ODYSSEY INTRAOCULAR LENS (IOL) IN THE LEFT EYE AND SHE COULD NOT TOLERATE THE HALOS. THE DOCTOR ALLOWED 6 MONTHS TO ADAPT, BUT PATIENT SAID IT HASN'T GOTTEN BETTER, SO THE DOCTOR PLANNED TO EXCHANGE IT FOR THE DCB00 IOL. ADDITIONAL INFORMATION INDICATED THAT THE ODYSSEY LENS WAS EXPLANTED AND REPLACED WITH DCB00 LENS IN SECONDARY SURGICAL PROCEDURE AS PATIENT WAS UNABLE TO TOLERATE ODYSSEY LENS. THERE WAS NO PATIENT INJURY AND POST PROCEDURE THE PATIENTS VISION WAS STABLE AND HEALING. THE ORIGINAL LENS IS NOT AVAILABLE FOR RETURN AS IT WAS CUT IN HALF DURING EXPLANT AND DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Halo
MAUDE report 23273764 ↗InjurySep 7, 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. THE REASON FOR THE EXPLANT IS DUE TO THE PATIENT EXPERIENCING HALOS AND GLARES. FOLLOW-UP IS BEING PERFORMED HOWEVER TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Halo; Visual Disturbances
MAUDE report 22989582 ↗InjurySep 3, 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 REMOVED FROM A PATIENT¿S RIGHT EYE DUE TO INCORRECT INTRAOCULAR LENS POWER. THE LENS WAS EXPLANTED DURING SECONDARY SURGICAL PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY, SURGICAL OR MEDICAL INTERVENTIONS, OR PRESCRIBED MEDICATIONS TO PREVENT PERMANENT IMPAIRMENT. THE PATIENT OUTCOME WAS REPORTED AS LOOPY DUE TO POST-OP. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Eye Injury
MAUDE report 22959894 ↗InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PRE-LOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE VISUAL OUTCOMES DID NOT MEET EXPECTED STANDARDS AND THE PATIENT WAS DISSATISFIED. THE PATIENT COMPLAINED OF BLURRINESS IN THE PERIPHERY, WHICH AFFECTED DAILY ACTIVITIES. THE HIGHER-ORDER ABERRATIONS INITIALLY PRESENT WERE RESOLVED AFTER THE EXPLANT. NO INJURY OR INTERVENTION WAS REQUIRED. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH AN UNKNOWN IOL. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 22891871 ↗InjuryAug 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE ODYSSEY INTRAOCULAR LENS WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO NIGHT-TIME DYSPHOTOPSIAS AND POOR INTERMEDIATE VISION. PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY (BSCVA) WAS 20/20 AND POST-OPERATIVE BCVA WAS 20/20-1. DIRECTIONS FOR USE WERE FOLLOWED. MEDICAL ATTENTION AND MEDICATION OUTSIDE OF STANDARD CARE WERE NOT REQUIRED. NO DEBILITATING CONDITION. PATIENT WAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 22768168 ↗MalfunctionAug 5, 2025Scratched Material; Scratched Material
IT WAS REPORTED BY THE CUSTOMER THAT THE LENS WAS DAMAGED ON THE POSTERIOR SIDE, SPECIFICALLY WHERE THE RINGS ARE, DESCRIBING IT AS EITHER A SCRATCH OR A CRACK IN THE PERIPHERY OF THE LENS. THE CUSTOMER DOES NOT BELIEVE THE LENS WAS LOADED INCORRECTLY AND DID NOT FEEL ANY RESISTANCE DURING THE IMPLANTATION. THE LENS WAS NOT REMOVED, AND THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22722890 ↗MalfunctionJun 27, 2025Mechanical Problem; Scratched Material; Mechanical Problem; Scratched Material
IT WAS REPORTED THAT INTRAOCULAR LENS HAD A MARK ON THE OPTIC SURFACE THAT WAS NOTED AFTER IMPLANTATION. THE LENS WAS REMOVED FROM THE EYE AND DISCARDED. IT WAS STATED THAT THE MARK MAY HAVE BEEN CAUSED BY A FAILURE IN THE PRELOADED MECHANISM. SURGERY WAS COMPLETED WITHIN THE SAME PROCEDURE. NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22350476 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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