AcrySof™ IQ PanOptix™ UV IOL TFAT00 (REF TFAT00.200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652429719), received between Aug 18, 2022 and Sep 27, 2023 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 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 17823674 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT, AFTER A MONTH OF SURGERY THE PATIENT STARTED HAVING THE SYMPTOMS. IT WAS ALSO STATED THAT PATIENT HAD REDNESS, ITCH, HALOS AND CANT SEE BLURRED EVERYTHING. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE 1 OF 2.

  Patient problems: Blurred Vision; Halo; Itching Sensation; Red Eye(s)

  MAUDE report 16253624 ↗
• InjuryNov 25, 2022Adverse 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, THE PATIENT EXPERIENCED STARBURST, AND HALOS AROUND LIGHTS. CONSUMER'S DOCTOR DID A LENS EXCHANGE IN BOTH EYES WITH THE COMPANY LENS. DOCTOR DID DO A LASER TREATMENT TO TRY TO HELP BUT IT MADE IT WORSE BOTH EYES. CONSUMER CAN'T DRIVE AT NIGHT BECAUSE OF THE ONCOMING LIGHTS AND ALL THE STARBURSTS AND HALOS, EVERYTHING IS DISTORTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THAT SYMPTOMS STARTED IMMEDIATELY AFTER SURGERY. HAS SEEN RETINAL SPECIALIST AND FINDINGS WERE NORMAL. USING SPECIAL SUN GLASSES TO FUNCTION INDOORS. HAS LEFT HIS JOB BECAUSE OF DEBILITATING GLARE AND IMPACT ON DAILY LIVING ACTIVITIES. HAS SEEN DIFFERENT SECOND OPINION SURGEONS. HAS BEEN ON VUITY DROPS WITH NO IMPROVEMENT OVER TIME. DOES NOT RECOMMEND IOL EXCHANGE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 15864715 ↗
• InjuryNov 25, 2022Adverse 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, THE PATIENT EXPERIENCED STARBURST, AND HALOS AROUND LIGHTS. CONSUMER'S DOCTOR DID A LENS EXCHANGE IN BOTH EYES WITH THE COMPANY LENS. DOCTOR DID DO A LASER TREATMENT TO TRY TO HELP BUT IT MADE IT WORSE BOTH EYES. CONSUMER CAN'T DRIVE AT NIGHT BECAUSE OF THE ONCOMING LIGHTS AND ALL THE STARBURSTS AND HALOS, EVERYTHING IS DISTORTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THAT THE SYMPTOMS STARTED IMMEDIATELY AFTER SURGERY. HAS SEEN RETINAL SPECIALIST AND FINDINGS WERE NORMAL. USING SPECIAL SUN GLASSES TO FUNCTION INDOORS. HAS LEFT HIS JOB BECAUSE OF DEBILITATING GLARE AND IMPACT ON DAILY LIVING ACTIVITIES. HAS SEEN DIFFERENT SECOND OPINION SURGEONS. HAS BEEN ON VUITY DROPS WITH NO IMPROVEMENT OVER TIME. DOES NOT RECOMMEND IOL EXCHANGE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 15864655 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT WAS NOT ABLE TO ADAPT WITH THE LENS. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION AHS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 15247356 ↗