AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652357661), received between Oct 25, 2021 and Apr 9, 2024 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2024Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  AN OPHTHALMIC NURSE REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THERE WAS MARK OBSERVED ON LENS AND THE HAPTIC WAS TWISTED. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM. THE SURGERY WAS COMPLETED USING A BACKUP LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. THE PATIENT WAS DISCHARGED AFTER THE NEW LENS WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070672 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NONHEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED HALOS AND GLARE AND COULD NOT ADAPT TO THE COMPANY LENS AND FOUND IT DIFFICULT TO PERFORM CERTAIN DAILY FUNCTIONS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 17823418 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NONHEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED HALOS AND GLARE AND COULD NOT ADAPT TO THE COMPANY LENS AND FOUND IT DIFFICULT TO PERFORM CERTAIN DAILY FUNCTIONS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 17807337 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DISCOMFORT AND VISION WAS VERY POOR ACUITY. THIS WAS ESPECIALLY TROUBLESOME IN SITUATIONS WHERE PATIENT HAD TO SPEND A LONG TIME IN FRONT OF THE COMPUTER OR IN OTHER TASKS THAT REQUIRE PRECISION AND FOCUS. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Discomfort; Visual Impairment

  MAUDE report 17098122 ↗
• InjuryFeb 7, 2023Application Program Problem: Power Calculation Error; Adverse Event Without Identified Device or Use Problem; Application Program Problem: Power Calculation Error; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAS A VERY GOOD POSTOPERATIVE RESULT AND UNFORTUNATELY HE IS NOT SATISFIED. POST OPERATIVELY SEVEN MONTHS PATIENT HAD CONSTANT CONTRAST DEFICIT (SEEING AS IF THROUGH A THIN WAX WICK) AND DIM HEAD FEELING, CONSTANT BLURRED VISION IN THE EXTENDED NEAR RANGE, CONSTANT, UNSATISFACTORY PERCEPTION OF THE ENVIRONMENT IN ARTIFICIAL, ESPECIALLY DIM LIGHTING (AS IF INTOXICATED), CONSTANTLY EXTREME HALOS WHEN WORKING WITH DIGITAL OUTPUT DEVICES, SUCH AS SMARTPHONES, NOTEBOOKS, ETC. (BACKLIGHTING), READING MAGAZINES/BOOKS ONLY POSSIBLE IN (BRIGHT) DAYLIGHT FOR A SHORT TIME (< 30 MINUTES) (PROBLEM: CONCENTRATION PROBLEMS, EYE FLICKER), NO DEPTH PERCEPTION UNDER ARTIFICIAL ILLUMINATION AT CLOSE RANGE (E.G., MOLD ON FOOD IS OFTEN NOT DETECTED!), POSTOPERATIVE, HIGHER LIGHT SENSITIVITY, GLARE UNPLEASANT ESPECIALLY WITH REFLECTED LIGHT ON METAL SURFACES, FREQUENT DULL (HEAD) HEAVINESS AND EARLY FATIGUE (UNUSUAL NEED FOR SLEEP ALREADY AT MIDDAY), OFTEN IRRITATED (DRY) EYES (DROPS BRING RELIEF), ONLY SILHOUETTE PERCEPTION IN BACKLIGHT (FACES NOT PERCEPTIBLE). THE PATIENT ALSO VISITED POST OPERATIVELY 11 MONTHS

  Patient problems: Blurred Vision; Fatigue; Halo; Headache; Irritability; Visual Disturbances; Visual Impairment

  MAUDE report 16311805 ↗
• InjuryFeb 7, 2023Application Program Problem: Power Calculation Error; Adverse Event Without Identified Device or Use Problem; Application Program Problem: Power Calculation Error; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAS A VERY GOOD POSTOPERATIVE RESULT AND UNFORTUNATELY HE IS NOT SATISFIED. POST OPERATIVELY SEVEN MONTHS PATIENT HAD CONSTANT CONTRAST DEFICIT (SEEING AS IF THROUGH A THIN WAX WICK) AND DIM HEAD FEELING, CONSTANT BLURRED VISION IN THE EXTENDED NEAR RANGE, CONSTANT, UNSATISFACTORY PERCEPTION OF THE ENVIRONMENT IN ARTIFICIAL, ESPECIALLY DIM LIGHTING (AS IF INTOXICATED), CONSTANTLY EXTREME HALOS WHEN WORKING WITH DIGITAL OUTPUT DEVICES, SUCH AS SMARTPHONES, NOTEBOOKS, ETC. (BACKLIGHTING), READING MAGAZINES/BOOKS ONLY POSSIBLE IN (BRIGHT) DAYLIGHT FOR A SHORT TIME (< 30 MINUTES) (PROBLEM: CONCENTRATION PROBLEMS, EYE FLICKER), NO DEPTH PERCEPTION UNDER ARTIFICIAL ILLUMINATION AT CLOSE RANGE (E.G., MOLD ON FOOD IS OFTEN NOT DETECTED!), POSTOPERATIVE, HIGHER LIGHT SENSITIVITY, GLARE UNPLEASANT ESPECIALLY WITH REFLECTED LIGHT ON METAL SURFACES, FREQUENT DULL (HEAD) HEAVINESS AND EARLY FATIGUE (UNUSUAL NEED FOR SLEEP ALREADY AT MIDDAY), OFTEN IRRITATED (DRY) EYES (DROPS BRING RELIEF), ONLY SILHOUETTE PERCEPTION IN BACKLIGHT (FACES NOT PERCEPTIBLE). THE PATIENT ALSO VISITED POST OPERATIVELY 11 MONTHS

  Patient problems: Blurred Vision; Fatigue; Halo; Headache; Irritability; Visual Disturbances; Visual Impairment

  MAUDE report 16311662 ↗
• InjuryJan 31, 2023Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PHYSICIAN FOUND TO HAVE SOME SUSPECTED SCRATCHES. THE PHYSICIAN DECIDED TO IMPLANT THE IOL INTO THE PATIENT'S EYE. THE PATIENT'S SIGHT WAS IMPACTED AFTER THE SURGERY SO THE PHYSICIAN REPLACED IT WITH ANOTHER IOL. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Visual Disturbances

  MAUDE report 16270334 ↗
• MalfunctionApr 19, 2022Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, POST IOL INSERTION INTO THE EYE A TRANSVERSE LINEAR SIGN ON THE OPTICAL PLATE THAT AFFECTED THE CENTRAL PORTION WAS NOTED. THE SURGERY WAS COMPLETED ON THE SAME DAY USING A BACK-UP LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AS THE REPORTER IS UNWILLING TO FOLLOW-UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140067 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT, FOLLOWING AN INTRAOCULAR LENS IMPLANTATION, THE PATIENT HAD A FEELING OF 'SMUDGE' IN HER VISION WHICH BOTHERS HER AT BOTH DISTANCE AND NEAR. THE IOL WAS EXCHANGED FOR A MONOFOCAL LENS APPROXIMATELY 6 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE TO MATCH HER RIGHT EYE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 12689920 ↗