AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380652418713), received between Apr 27, 2021 and Feb 14, 2024 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 16, 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.

• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED, THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. POST 2 YEARS, THE PATIENT HAD POOR QUALITY OF VISION. COULDN'T SEE THE SMALL PRINT ON THE TV, NOR READ UP CLOSE AND NEEDED A LOT OF LIGHT TO SEE. THE SURGEON DID A LASER PROCEDURE TO HELP. AND IT HAS NOT. THE VISION WAS "DRIVING HIM CRAZY". THE SURGEON WAS UNABLE TO UNDERSTAND WHY HE WAS NOT SEEING WELL. SURGEON HAS DONE A LOT OF TESTING IN THE OFFICE AND SAYS HIS VISION WAS FINE. ADDITIONAL INFORMATION HAS BEEN RECEIVED, THAT PATIENT QUALITY VISION WAS DECREASING. THE YAG LASER WAS DONE, BUT STILL THE VISION WAS DETERIORATING. THE SURGEON AND OPTOMETRIST SAID, THAT NUMBERS LOOK GOOD. AND NO CLINICAL REASON FOUND. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 18701422 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE REASON FOR THE EXPLANT WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THERE WAS NO PATIENT HARM AND ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15823496 ↗
• InjuryNov 17, 2022Material Opacification; Adverse Event Without Identified Device or Use Problem; Material Opacification; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION CLOSE AND FAR, NOT HAPPY AND ALSO LASER AFTER THE SURGERY. ADDITIONAL RECEIVED AND STATED THAT THE PATIENT EXPERIENCED CLOUDY BOTH NEAR AND FAR, HARD TO SEE AND ALSO NOT REALLY FLOATERS BUT LIKE ALWAYS LOOKING THROUGH A FOG. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH FILE 1 OF 2.

  Patient problems: Blurred Vision; Dry Eye(s)

  MAUDE report 15812495 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED FOLLOWING IMPLANTATION OF INTRAOCULAR LENS, THE PATIENT EXPERIENCED GLARE, BLURRED VISION, HALO AND STARBURST EFFECTS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Halo; Visual Disturbances

  MAUDE report 15769313 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED HALOS WHICH OBLITERATED HER EARLY EVENING AND NIGHT VISION. THE HALOS WERE SO BIG TAKING OVER THE ENTIRE ROAD. SHE COULD NOT SEE TO SAFELY MAKE TURNS. THOUGH AFTER WAITING THE APPROPRIATE SETTLE-IN TIME SUGGESTED BY HER DOCTOR, HALOS DID NOT GO AWAY. HER EYES FELT LIKE THEY WERE UNDER WATER ALL THE TIME. ADDITIONAL INFORMATION WAS RECEIVED STATING SHE EXPERIENCED HALOS FRONT THE START, THINGS FELT BLURRIER AND HER DEPTH PERCEPTION WAS OFF. THE LOW CONTRAST WAS DISCONCERTING WHEN DRIVING AND SHE HAD TO BUY SEVERAL PAIRS OF DIFFERENT SUNGLASSES TO HELP PROVIDE MORE CONTRAST. LOW LIGHT INDOORS WAS NOT GOOD. SHE HAD TUMBLED OFF A STAIRCASE TWICE BECAUSE SHE COULD NOT SEE THE LAST STEP. SHE WAS SO DISAPPOINTED WITH THE OUTCOME OF HER SURGERIES. SHE WAS HOPING THAT THE HALOS WILL GO AWAY. SHE WAS NOT BEING ABLE TO DRIVE HOME AT NIGHT. THE HALOS OBLITERATE THE VIEW ON THE ROAD IN THE DISTANCE GROWING LARGER AND LARGER AS VEHICLES GET CLOSER. THE AREA OF THE HALO WAS LARGER THAN THAT OF THE CAR, REACHING ABOVE, BELOW AND LEFT AND RIGHT SIDES, SPI

  Patient problems: Blurred Vision; Eye Pain; Halo; Headache; Hyporesponsive to stimuli; Visual Disturbances; Visual Impairment

  MAUDE report 15735063 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD DISPLEASED SARANWRAP VISION THAT DOES NOT IMPROVE OR GO AWAY. THE IOL WAS EXCHANGED FOR ANOTHER LENS APPROXIMATELY 8 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT, THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE PATIENT WAS NOT HOSPITALIZED. PATIENT'S ISSUES WERE RESOLVED.

  Patient problems: Visual Impairment

  MAUDE report 15400067 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISUAL ACUITY AND GHOSTING IMAGES WHEN READING. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR THE EXPLANT WAS RESIDUAL ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 15218890 ↗
• InjuryApr 4, 2022Adverse 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 UNHAPPY WITH READING AND HAVING VISUAL DISTURBANCE AND HALOS AT NIGHT. THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT SURGEON PROGNOSIS WAS GOOD, PATIENT ISSUE WAS RESOLVED AND PATIENT WAS NOT HOSPITALIZED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 13996053 ↗
• MalfunctionMar 23, 2022Scratched Material; Scratched Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THERE WAS A SCRATCH ON THE LENS AND WAS REMOVED AND REPLACED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13856102 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISUAL DISTORTION, GLARE AND HALOS. PATIENT WAS NOT TOLERATING THE LENS. THE LENS WAS EXCHANGED FOR A DIFFERENT LENS 3 MONTHS AFTER INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12910775 ↗
• InjuryOct 22, 2021Defective Device; Defective Device

  A CUSTOMER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THERE WAS A PROBLEM WITH THE LENS AND PATIENT CAN NOT SEE AS WELL CORRECTED AS PREOPERATIVE CORRECTED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED REPORTING THAT THE PATIENT EXPERIENCED VISION BLURRY SINCE FEW WEEKS AFTER SURGERY, VISION IS OFF AND WAXY. PATIENT ALSO HAS BLINDING GLARE FROM HEADLIGHTS AND CAN NOT DRIVE AT NIGHT. THE PATIENT CAN NOT SEE BOTTOM LINE AS WELL WITH GLASSES AS WITH GLASSES PREOPERATIVE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12685833 ↗
• InjuryOct 22, 2021Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THERE WAS A PROBLEM WITH THE LENS AND PATIENT CANNOT SEE AS WELL CORRECTED AS PREOPERATIVE CORRECTED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED REPORTING THAT THE PATIENT EXPERIENCED VISION BLURRY SINCE FEW WEEKS AFTER SURGERY, VISION IS OFF AND WAXY. PATIENT ALSO HAS BLINDING GLARE FROM HEADLIGHTS AND CAN NOT DRIVE AT NIGHT. THE PATIENT CANNOT SEE WELL WITH GLASSES AS SHE DID WITH GLASSES PREOPERATIVELY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12685460 ↗
• InjuryOct 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) PATIENT EXPERIENCED GLARE WHEN DRIVING AT NIGHT. THE LENS WAS LATER EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 12649644 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE INTRAOCULAR LENS (IOL) WAS REPLACED WITH ANOTHER IOL.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 12372461 ↗
• InjuryJul 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS DISLOCATED. THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL IOL AND PLACED IN THE SULCUS, AND AN ANTERIOR VITRECTOMY WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12218869 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED HALOS AROUND LIGHTS/UNHAPPY, PATIENT DOES NOT LIKE TO DRIVE AT NIGHT DUE TO HALOS. POST IMPLANTATION AFTER 10 MONTHS THE LENS WAS REPLACED WITH DAT315 20.5. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo

  MAUDE report 12099594 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN HAS REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT HAS EXPERIENCED INTOLERABLE NIGHT VISION DUE TO GLARE AND HALOS. ADDITIONAL INFORMATION WAS PROVIDED THAT THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL IOL WITH 0.5D POWER DIFFERENCE IN A SECONDARY PROCEDURE.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 12048395 ↗
• InjuryApr 27, 2021Scratched Material; Scratched Material

  A CUSTOMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT REPORTED SEEING A LINE IN VISION. THE LENS WAS REPORTED TO HAVE A SCRATCH ON IT AND THE PATIENT HAD POOR VISION. THE IOL WAS EXCHANGED APPROXIMATELY THREE MONTHS AFTER THE INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 11733425 ↗