AcrySof™ IQ PanOptix™ UV IOL TFAT00 (REF TFAT00.215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380652429740), received between May 10, 2022 and Apr 2, 2025 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRY VISION, HALOS AND GLARE. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS BLURRY VISION, HALOS, GLARE AND NON ADAPTION OF THE LENS.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 21754920 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT REASON WAS UNABLE TO ADAPT. THE IOL WAS REPLACED WITH MONOFOCAL LENS APPROXIMATELY SIX MONTHS AFTER INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: Visual Impairment

  MAUDE report 21422382 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD GLARE. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL), 1 YEAR AND 7 MONTHS AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON WAS UNSATISFACTION WITH VISION AND GLARE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 20358434 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE,THINGS ARE WASHED OUT IN LEFT EYE. LENS WAS EXPLANTED IN A SECONDARY PROCEDURE APPROXIMATELY SEVEN MONTHS AFTER INITIAL IMPLANTATION. REPLACED WITH MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT WAS SUBJECTIVE VISUAL DISTURBANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 18442848 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT SEEING RINGS. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 7 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED, AS PER SURGEON OPINION THERE WAS NO PROBLEM WITH THE IOL, HOWEVER AS PER THE PATIENT'S PREFERENCE THE IOL WAS REPLACED WITH ANOTHER COMPANY LENS.

  Patient problems: Visual Disturbances

  MAUDE report 17930419 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED SEVERE PAIN AND ANXIETY. AFTER THE SURGERY, THE PATIENT HAD SEVER PAIN AND THE NEXT DAY, THE DOCTOR EXAMINED THE PATIENT AND IDENTIFIED THAT INTRAOCULAR PRESSURE HAS INCREASED. THE PHYSICIAN THEN INSERTED THAT NEEDLES IN THE PATIENT'S EYE TO DRAIN THE FLUID TO REDUCE THE INTRAOCULAR PRESSURE. THE PATIENT STILL HAD SEVERE PAIN, BLURRED VISION AND VISION IMPAIRMENT. THE PHYSICIAN THEN PRESCRIBED A SERIES OF ANTIBIOTIC, STEROIDS AND LUBRICANTS TO REDUCE THE PATIENT'S PAIN. THE PHYSICIAN THEN SUGGESTED THE PATIENT TO TAKE A SECOND OPINION. THE SECOND PHYSICIAN SUGGESTED THAT THE PATIENT MIGHT BE ONE OF THE 3 PERCENT OF THE PEOPLE WHOSE EYES DID NOT ADAPT TO THE LENS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE BY THE SECOND PHYSICIAN. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT WAS ALSO HAVING SOME FLASHES, FLOATERS AND HE WAS HAVING SOME FLUCTUATING VISION AND DESCRIBED SYMPTOMS CONSISTENT WITH DRY EYE SYNDROME WHICH WAS POSSIBLY AGGRAVATED AS A SIDE EFFECT OF SOME POST OPERATIVE MEDICATION. THE PATIENT ALSO HAD CON

  Patient problems: Anxiety; Blurred Vision; Dry Eye(s); Eye Pain; Inflammation; Intraocular Pressure Increased; Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 17815844 ↗
• InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MATERIALS MANAGEMENT REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT COULD NOT TOLERATE THE LENS, PATIENT HAD HALOS AT NIGHT. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION RECEIVED STATED THAT IOL IMPLANTATION PROCEDURE WAS PERFORMED IN RIGHT EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo

  MAUDE report 17630280 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH OTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS POOR VISION- MYOPIC/RETROACTIVE SURPRISE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17118835 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MATERIALS MANAGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD INTOLERABLE GLARE AND POOR BCVA. AFTER ALL ATTEMPTS AT ADJUSTING, INCLUDING AN IOL ROTATION, THE DECISION WAS MADE TO UNDERGO AN IOL EXCHANGE. THE LENS WAS REPLACED WITH ANOTHER COMPANY LENS. THERE WAS NO PATIENT HARM AND PATIENT'S ISSUES WERE RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 17001615 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO TOLERATE IMPLANT WITH POOR QUALITY OF VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT MENTIONED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 16970093 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT WAS DISSATISFIED WITH VISION, SHE HAD LIGHT SENSITIVITY ISSUES. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A NON COMPANY MONOFOCAL LENS. THE CLINICAL REASON FOR EXPLANT WAS FOGGY VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 16723150 ↗
• InjuryApr 3, 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 CIRCLES AROUND LIGHTS AND INCREASED LIGHT INTENSITY AT NIGHT, THIS NEGATIVELY IMPACTED ABILITY TO DRIVE AT NIGHT, DEPTH PERCEPTION WAS IMPACTED AND YAG SURGERY WAS CONDUCTED BUT HAD NOT SEEN AN IMPROVEMENT. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE 1 OF 2 EYES.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 16665560 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, EXPERIENCED DIFFICULTY WITH CONCENTRIC CIRCLES AROUND LIGHTS AND INCREASED LIGHT INTENSITY AT NIGHT, WHICH NEGATIVELY IMPACTS THE ABILITY TO DRIVE AT NIGHT BECAUSE OF THE ENORMOUS CAR LIGHTS, AND DEPTH PERCEPTION WAS IMPACTED AS WELL. THE CONSUMER TRIED EYE DROPS, BLUE GLASSES, YELLOW GLASSES AND YAG SURGERY, BUT HAD NOT SEEN ANY IMPROVEMENT IN THIS PROBLEM. THE CONSUMER REPORTED THAT IT HAS BEEN 18 MONTHS NOW BUT STILL HAVE TO LIVE WITH THESE DIFFICULTIES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Visual Impairment

  MAUDE report 16654562 ↗
• InjuryMar 28, 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 INTOLERABLE VISUAL ABERRATION AND GLARE. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT WAS TREATED WITH YAG LASER POSTERIOR CAPSULOTOMY AFTER SURGERY. PATIENT VISION WAS IMPROVED BUT NOT GREAT. SHE STATED VISION WAS BETTER AT DISTANCE THAN NEAR, THOUGH IT WAS PRETTY BLURRY EVERYWHERE. SHE COULD READ TABLET WHEN MAKING FONT LARGER, BUT COULD NOT READ BOOK, COULD NOT READ SUBTITLES ON THE TV. SHA HAD SNOWFLAKES AND STARBUST WHEN DRIVING AT NIGHT. THERE WERE FLOATERS IN THE RIGHT EYE. PATIENT ALSO HAD DERMATOCHALASIS, TRACE BLEPHARITIS ANTERIOR AND TRACE BLEPHARITIS POSTERIOR, CONJUNCTIVA- TRACE INJECTION AND PINGUECULUM, VITREOUS SYNERESIS/OPACITIES, MILD ASYMMETRIC SURFACE ON TOPOGRAPHY WITH FEW PERIPHERAL MICROCYSTS, TRACE MEIBOMIAN GLAND DYSFUNCTION, MILD EYE PAIN AND DRY EYES. THE PATIENT HAD BEEN ADVISED TO TAKE, ANTIBIOTIC, NSAIDS AND STEROID DROPS. PATIENT CONDITION HAD BEEN IMPROVED AFTER REPLACEMENT WITH MONOFOCAL LENS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Dry Eye(s); Eye Pain; Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 16626331 ↗
• MalfunctionMar 21, 2023Defective Component; Defective Component

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD A NICK IN IT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16583663 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL COORDINATOR REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT¿S VISUAL OUTCOME WAS NOT AS EXPECTED. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 16213800 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH VISUAL OUTCOME WITH LENS. THE LENS WAS LATER EXCHANGED WITH A NON-COMPANY LENS IN A SECONDARY PROCEDURE. THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 15622578 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT WAS NOT SATISFIED WITH THE OUTCOME AND COMPLAINED OF BEING BLUR. THE LES WAS EXPLANTED IN A SECONDARY PROCEDURE. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 14346727 ↗