TECNIS IOL ZXR00 (REF ZXR00U0190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 05050474579071), received between Feb 24, 2017 and Dec 29, 2023 — classified as 66 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE EXTENDED RANGE OF VISION NON PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. THE LENS WAS REPLACED WITH LENS MODEL ZXT150 20.0 DIOPTER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 18418839 ↗
• MalfunctionAug 13, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED FROM THE PATIENT'S EYE IN SAME PROCEDURE DUE TO A BENT/BROKEN HAPTIC. THE REMOVED IOL WAS REPLACED WITH A BACK-UP LENS OF THE SAME MODEL AND DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED. NO FURTHER INFORMATION IS AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321816 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 MODEL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO DYSPHOTOPSIA AND NOT TOLERATING RINGS OF MULTIFOCAL IMPLANT. PATIENT HAS BLURRED VISION. THE REPLACEMENT LENS USED IS OF DIFFERENT MODEL AND DIOPTER. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12167238 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING THE BLURRINESS AND HALOS WITH AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE. THE PATIENT WAS FITTED FOR DIFFERENT TYPES OF CONTACT LENSES TO MIMIC A PHOTOREFRACTIVE KERATECTOMY (PRK), BUT NONE OF THE CONTACT LENSES WORKED. THEREFORE, THE LENS WAS EXPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. THERE WAS NO VITRECTOMY OR SUTURES REQUIRED. THE PATIENT IS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 11342055 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXR00 INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT''S LEFT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO MECHANICAL COMPLICATION, AND A VITRECTOMY WAS REQUIRED. THROUGH FOLLOW-UP CLARIFICATION WAS PROVIDED REGARDING THE REPORTED MECHANICAL COMPLICATION BEING A HYPEROPIC MISS. THERE WAS NO PRODUCT QUALITY ISSUE. PATIENT DID NOT EXPERIENCE ANY KIND OF VISUAL DISTURBANCE. DURING THE EXPLANT AN ANTERIOR VITRECTOMY WAS PERFORMED DUE TO OPEN POSTERIOR CAPSULE. THE REPLACEMENT LENS USED IS A NON-JOHNSON & JOHNSON VISION LENS. THE PATIENT WAS REPORTED TO BE DOING WELL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear; Therapeutic Effects, Unexpected; Vitrectomy

  MAUDE report 10834609 ↗
• MalfunctionSep 17, 2020Contamination; Contamination

  IT WAS REPORTED THAT THE DOCTOR NOTICED SOMETHING STICKY ON THE BACK SIDE OF THE INTRAOCULAR LENS (IOL) IMPLANTED IN A PATIENT'S RIGHT EYE. THE SUBSTANCE WAS DIFFICULT TO REMOVE, BUT THEY WERE ABLE TO PULL IT OFF THE IOL, SO IT WAS CLEARLY STUCK TO IT BEFORE THE IOL WAS INSERTED. THE DOCTOR WAS ABLE TO KEEP THE SAME LENS IN THE PATIENT'S EYE AND DID NOT HAVE ANY OTHER ISSUES. REPORTEDLY, THE SCRUB TECH DID NOT SEE ANYTHING ON THE LENS BUT IT WAS NOTED THAT THE SUBSTANCE WAS SO SMALL THAT IT COULD NOT BE SEEN UNLESS UNDER A MICROSCOPE. THEY DID NOT SEE ANYTHING ON THE CARTRIDGE BEFORE THE SURGERY. THEY SENT THE FOREIGN SUBSTANCE TO PATHOLOGY; HOWEVER, IT WAS LATER INDICATED THAT THE SPECIMEN RETRIEVED WHICH WAS A VERY TINY PIECE DID NOT SURVIVE PROCESSING AT THE PATHOLOGY LAB. IT WAS NOTED THAT THE CONCOMITANT DEVICE, CARTRIDGE WAS ALSO DISCARDED BY THE ACCOUNT. THERE WAS NO VITRECTOMY OR INCISION ENLARGEMENT REQUIRED AND NO SUTURES WERE USED. THERE WAS NO PATIENT INJURY REPORTED. IT WAS CONFIRMED THAT THE PATIENT WAS FINE AND NOT EFFECTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10544914 ↗
• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE HYPEROPIC ASTIGMATISM. THE EXPLANTED LENS WAS REPLACED WITH A MODEL ZXT150, 20.0 DIOPTER IOL. IT WAS STATED THAT NO PRODUCT WILL BE RETURNED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10470256 ↗
• InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS PLANNED FOR AN EXPLANT DUE TO INTOLERABLE GLARE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 10398909 ↗
• MalfunctionJul 22, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 1</NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10310984 ↗
• InjuryApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXR00 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. THE ZXR00 19.0 DIOPTER LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO COMPLAINTS OF INCORRECT LENS POWER/FOR POWER. THERE WAS NO PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY HOWEVER THE INCISION WAS ENLARGED. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9949394 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAS BILATERAL ZXR00 INTRAOCULAR LENSES (IOL) IMPLANTED. HOWEVER, THE PATIENT IS EXPERIENCING CIRCLES AND GLARE IN THE FORM OF A HUGE STARBURST AT NIGHT, WHICH HAS LIMITED THE PATIENT FROM DRIVING AT NIGHTTIME. THE SYMPTOMS ARE ALMOST IDENTICAL IN EACH EYE. BOTH LENSES ARE STILL IMPLANTED. PATIENT HAS SEEN HIS EYE DOCTOR MULTIPLE TIMES AND WAS USING EYE DROPS. PER THE PATIENT, NOTHING HAS WORKED TO BETTER HIS NIGHT VISION. PATIENT STATES DAY VISION IS PERFECT BUT IS CONSIDERING A SECOND OPINION TO ADDRESS NIGHT VISION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE EVENT FOR THE LEFT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Blurred Vision; Halo; No Code Available; Visual Disturbances

  MAUDE report 9795570 ↗
• InjuryJan 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HALOS AND STARBURSTS AT NIGHT. VISUAL ACUITY PRE-OPERATIVE (OP) WAS 20/30 AND VISUAL ACUITY POST-OP WAS 20/30. THE LENS WAS EXPLANTED. FURTHER INFORMATION WAS PROVIDED AND THERE WERE NO VITRECTOMY OR SUTURES REQUIRED. THE PATIENT'S VISION HAS IMPROVED, BUT STILL COMPLAINS OF STARBURSTS. THE LENS WAS REPLACED A NON-JOHNSON & JOHNSON REPLACEMENT LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9625371 ↗
• InjuryDec 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT A MODEL ZLB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN HIS LEFT EYE, AND HE WAS HAPPY WITH IT ALTHOUGH THERE WAS VERY MINIMAL GLARE AND HALO WHICH WAS EXPECTED. SLIGHTLY AMBLYOPIC IN THAT EYE SO EXPECTATION WAS NOT HIGH. HOWEVER, ALMOST A MONTH LATER HE WAS IMPLANTED A ZXR00 IOL IN HIS RIGHT EYE. OVER TIME THE PATIENT CLAIMED TO HAVE A FEW GLARE AND HALOS, BUT THEY ARE MINIMAL AND AT THIS POINT NOT AT ALL AN ISSUE. YET, HE REMAINED VERY HAPPY WITH HIS LEFT EYE. HIS NIGHT VISION WAS AS EXPECTED PRETTY POOR TO BEGIN WITH. AS TIME WENT ON HIS DAYLIGHT VISION BECAME SUPERB. HE IS FAR LESS DEPENDENT ON READERS THAN HE HAD BEEN PRE-OP. ALSO, BEGINNING RIGHT AFTER SURGERY HE HAD SIGNIFICANT ISSUE WITH BRIGHT LIGHTS AT NIGHT (E.G. CAR LIGHTS, STREET LIGHTS, ANY SORT OF SPOT TYPE LIGHT). HE SEES CLEARLY DEFINED SPIDER WEBS 100% OF THE TIME WHEN PRESENTED WITH DESCRIBED LIGHT CONDITIONS. HE RARELY DRIVES IN NON-DAYLIGHT HOURS. AS HE APPROACHED THE ONE-YEAR ANNIVERSARY HE BECAME CONCERNED THAT HE WILL BE STUCK WITH THIS CONDITION UNLESS HE HAS THE LENS REMOVED AND REPLACED WITH ANOTHER LENS. AS HE IS AMBLYOPIC, HE DOES NOT WANT THE RISK OF ANY SORT OF RETINAL COMPLICATI

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 9447151 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXR00 19.0 DIOPTER INTRAOCULAR LENS (IOL) MODEL WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. THE ZXR00 LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO COMPLAINTS OF BLURRY/CLOUDY VISION, LIKE SHE IS LOOKING THROUGH A CLOUD WITH A HOLE IN IT. THE ZXR00 LENS WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. IT WAS REPORTED THERE WERE NO COMPLICATIONS DURING ORIGINAL SURGERY OR LENS EXCHANGES, NO SUTURES, AND NO VITRECTOMY. THE PATIENT IS HEALTHY AND NOT TAKING ANY MEDICATIONS AND OUTCOME WAS REPORTED AS PATIENT IS DOING WELL POST EXCHANGES. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9365410 ↗
• InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 19.0 DIOPTER LENS WAS IMPLANTED IN THE STUDY PATIENT¿S RIGHT EYE (OD). THE PATIENT REPORTED EXPERIENCING SEVERE HALOS AND STARBURSTS. THE UCDVA (UNCORRECTED DISTANCE VISUAL ACUITY) FOR OD WAS 20/60. THE DOCTOR HAS SCHEDULED AN EXPLANT FOR THIS PATIENT. THERE WERE NO PATIENT COMPLICATIONS AND/OR RELATED INJURIES. AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT'S OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9301610 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT HE HAD SYMFONY INTRAOCULAR LENSES (IOLS) IMPLANTED IN BOTH HIS EYES. A MODEL ZXR00, 19.0 DIOPTER LENS WAS INSERTED IN THE PATIENT¿S LEFT EYE. THE PATIENT REPORTED THAT HE CAN SEE FAR BUT NOT NEAR. HE CANNOT SEE 12 INCHES IN FRONT OF HIM. HE HAD A YAG (YTTRIUM ALUMINUM GARNET) DONE, BUT IT DID NOT HELP MUCH. THRU FOLLOW-UP WITH THE PATIENT, IT WAS LEARNED THAT HE IS EXPERIENCING HALOS, STARBURSTS, AND HAS DIFFICULTY DRIVING AT NIGHT. THIS HAS BEEN HAPPENING SINCE HIS SURGERY. THE PATIENT OFTEN GOES FISHING, BUT THIS TASK IS DIFFICULT AS THE IOLS DO NOT ALLOW YOU TO SEE NEAR ENOUGH TO WORK WITH THE FISH HOOK. PATIENT STATED THAT HE DOES NOT THINK THERE IS ANYTHING WRONG WITH THE IOLS, AND EXPLAINED THAT HE WAS NOT WELL-INFORMED BEFORE THE SURGERY. NO FURTHER INFORMATION WAS PROVIDED. PATIENT HAS BILATERAL LENS IMPLANTS. THIS REPORT WILL CAPTURE THE PATIENT¿S LEFT EYE. A SEPARATE REPORT IS BEING FILED FOR THE RIGHT EYE.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9164972 ↗
• InjuryOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CAPSULAR BAG COLLAPSED AFTER INSERTION OF A MODEL ZXR00 INTRAOCULAR LENS (IOL). THE SURGEON CUT AND REMOVED THE LENS FROM THE RIGHT EYE AND REPLACED IT WITH ANOTHER LENS DURING THE SAME PROCEDURE. SUTURES WERE USED TO COMPLETE THE PROCEDURE. IT WAS INDICATED THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 9143830 ↗
• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE AS THE PATIENT WAS NOT HAPPY WITH THEIR VISUAL OUTCOME. THE EXPLANTED LENS WAS REPLACED WITH A DIFFERENT MODEL LENS BUT THE SAME DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9101089 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXR00 INTRAOCULAR LENS (IOL) WAS FROM EXPLANTED FROM THE PATIENT LEFT EYE DUE TO THE PATIENT EXPERIENCING HAZY, CLOUDY VISION, HUGE HALOS AROUND LIGHTS, LIGHT SENSITIVITY, AND STARBURSTS. VISION WAS DISTORTED. PATIENT¿S VISUAL ACUITY PRE-OPERATIVE 20/40, VISUAL ACUITY POST-OPERATIVE 20/40. AT EXPLANT/EXCHANGE IT WAS NOTED THAT SUTURES WERE REQUIRED, AND THE PATIENT HAS RECOVERED. THE EXPLANTED LENS IS NOT AVAILABLE FOR RETURN AS IT WAS NOTED TO BE DESTROYED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 8742907 ↗
• InjuryApr 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 +19.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT NOT HAPPY WITH VISUAL OUTCOME. REPORTEDLY THERE WAS NO PATIENT INJURIES, NO OTHER SURGICAL INTERVENTION, NO CONTRIBUTING MEDICAL HISTORY. PATIENT IS DOING FINE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8558339 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 INTRAOCULAR LENS (IOL) WAS IMPLANTED, HOWEVER THE PATIENT WAS NOT SEEING WELL. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER ZXR00 BUT A LOWER DIOPTER (18.5). IT WAS STATED THAT THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8534608 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY INTRAOCULAR LENS (IOL), MODEL ZXR00, 19.0 DIOPTER, WAS EXPLANTED FROM THE RIGHT EYE (OD) AS THE PATIENT EXPERIENCED GREAT VISUAL DISTURBANCE, SEVERE HALOS AND WAS UNABLE TO SEE AT NIGHT. REPORTEDLY, THE OUTCOME SIGNIFICANTLY INTERFERED WITH THE PATIENT'S DAILY LIFE ACTIVITIES. A ZCB00 19.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO INCISION ENLARGEMENT. IT WAS INDICATED THAT THE PATIENT HAS RECOVERED AND THE EXPLANTED LENS WAS DISCARDED BY THE ACCOUNT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 8513352 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY INTRAOCULAR LENS (IOL), MODEL ZXR00, 19.0 DIOPTER, WAS EXPLANTED FROM THE LEFT EYE (OS) AS THE PATIENT EXPERIENCED SEVERE VISUAL DISTURBANCE AND WAS UNABLE TO SEE AT NIGHT. REPORTEDLY, THE OUTCOME SIGNIFICANTLY INTERFERED WITH THE PATIENT'S DAILY LIFE ACTIVITIES. A ZCB00 19.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO INCISION ENLARGEMENT AND NO OTHER INJURY WAS REPORTED. IT WAS INDICATED THAT THE PATIENT HAS RECOVERED. THE EXPLANTED LENS WAS DISCARDED BY THE ACCOUNT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances; Visual Impairment

  MAUDE report 8513342 ↗
• InjuryApr 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT CALLED TO INQUIRE ABOUT HIS INTRAOCULAR LENS (IOL) AND TO ALSO SHARE HIS EXPERIENCE POST IMPLANT. REPORTEDLY, HE HAD ACUTE SWELLING THE FOLLOWING DAY (POST OP) WHICH HE DIDN¿T THINK WAS NORMAL. HE WAS SEEING BLACK DOTS. THE DOCTOR INFORMED HIM THAT THE BLACK DOTS WERE WHITE BLOOD CELLS. NO OTHER PATIENTS THAT DAY HAD ANY ISSUES. HIS SURGEON HAS DONE OVER 60,000 IMPLANTS WITH AN INFECTION RATE OF 1/20,000. THE NORMAL PREOP PROCESS WAS FOLLOWED; ALL WAS DONE CORRECTLY. HE WAS PRESCRIBED THE NORMAL PROTOCOL FOR POST OP DROPS. HIS SURGERY WAS (B)(6) 2019. ON FRIDAY, HIS SYMPTOMS STARTED. HE HAD BLURRINESS IN HIS OPERATIVE, RIGHT EYE. HE SPOKE WITH HIS DOCTOR ON FRIDAY, WHO INFORMED HIM THE BLURRINESS MIGHT LAST A DAY, OR A WEEK OR LONGER. BY SATURDAY, HE COULD NOT SEE. REPORTING OVER 1,000 FLOATERS. HE CONTACTED THE SURGEON¿S OFFICE AND SHARED HIS SYMPTOMS. HE SAW A DOCTOR WITHIN THE PRACTICE THAT SAME DAY. WHEN HE WENT OUTSIDE EVERYTHING WAS ''WHITE'' WITH THE FLOATERS. THE DOCTOR INFORMED HIM WHAT HE SAW WERE WHITE BLOOD CELLS WHICH WAS REPORTEDLY AN INFECTION. HE WAS THEN REFERRED TO A RETINAL SPECIALIST LATER THAT SAME DAY WHO DIAGNOSED AN ACUTE INFECTION. HE RECEIVED TWO

  Patient problems: Blurred Vision; Endophthalmitis; Swelling

  MAUDE report 8490070 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THERE WAS A MECHANICAL FAILURE AFTER THE IMPLANTATION OF LENS MODEL, ZXR00 MULTIFOCAL IOL (INTRAOCULAR LENS) IN PATIENT'S RIGHT EYE (OD). AS A RESULT, THE LENS WAS EXPLANTED. IT WAS ALSO NOTED THAT THERE WERE NO SECONDARY SURGICAL INTERVENTION SUCH AS SUTURE, INCISION ENLARGEMENT OR VITRECTOMY. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE PATIENT STARTED COMPLAINING IN (B)(6) 2019 OF BEING UNABLE TO SEE NEAR OR DISTANCE; VERY BOTHERSOME BY LIGHTS AND UNHAPPY WITH THEIR VISION. A ZCT150 +19.0 WAS IMPLANTED AS A REPLACEMENT. REPORTEDLY, THE PATIENT VISION HAS SEEMED TO IMPROVE BUT STILL BLURRED. THE ACCOUNT ALSO COMMENTED THAT THERE WAS NO ISSUE WITH INTEGRITY OF THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 8482741 ↗