TECNIS IOL ZXR00 (REF ZXR00U0200)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY ERV 20.0D · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This TECNIS Symfony lens is a synthetic extended-focus intraocular lens implanted during cataract surgery. The 66 reports mostly describe patients seeing halos, starbursts, and blurred or worsened vision afterward, with a few lenses removed and replaced because of these symptoms. There were 63 injuries and no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 66
- Deaths reported
- 0
- Injuries reported
- 63
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 05050474579095), received between Nov 2, 2016 and May 14, 2024 — classified as 63 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem53
- Inadequacy of Device Shape and/or Size4
- Unintended Movement3
- Scratched Material2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Device Contamination with Chemical or Other Material1
- Device Dislodged or Dislocated1
Patient problems
- No Code Available50
- Halo13
- Visual Disturbances11
- Blurred Vision10
- Visual Impairment9
- Capsular Bag Tear4
- Vitrectomy4
- Flashers2
Recent adverse event reports
The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A FEMALE PATIENT HAD BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS, BUT VISION IS NOW WORSE THAN EVER. THE PATIENT COMPLAINED TO DOCTOR ABOUT SEEING STARBURSTS AROUND CAR LIGHTS AND AURAS AROUND LIGHTS/STARS/THE MOON AT NIGHT. PATIENT COULD NO LONGER DRIVE COMFORTABLY AFTER DUSK. THE DOCTOR ASSURED PATIENT THAT IT SHOULD IMPROVE, AND THAT WHAT SHE WAS EXPERIENCING WAS ONLY TEMPORARY, AND SAID TO GIVE IT TIME. THE PATIENT DID, AND NOW, TWO YEARS LATER, VISION HAS NOT IMPROVED AND IF ANYTHING HAS GOTTEN WORSE. PATIENT NOW NOTICES/SEES AN AURA AROUND ANYTHING LIGHT OR BRIGHT. THESE HAPPEN WITH BOTH EYES EVEN DURING THE DAY. CAN SEE AURAS AROUND HER COMPUTER, THE TV, HER HAND, HER SILVERWARE AS SHE EATS, THE GLASS OF WATER NEXT TO HER COMPUTER, ETC. AT NIGHT VISION IS SIGNIFICANTLY WORSE AND THE PATIENT CAN NO LONGER DRIVE AFTER DUSK. IT NOW APPEARS THAT THE VISION ISSUE IS NOW PERMANENT. THIS MDR REPORT PERTAINS TO THE LEFT EYE (OS) OF THE PATIENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE (OD) OF THE PATIENT.
Patient problems: Flashers; Visual Disturbances
MAUDE report 19307317 ↗InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A FEMALE PATIENT HAD BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS, BUT VISION IS NOW WORSE THAN EVER. THE PATIENT COMPLAINED TO DOCTOR ABOUT SEEING STARBURSTS AROUND CAR LIGHTS AND AURAS AROUND LIGHTS/STARS/THE MOON AT NIGHT. PATIENT COULD NO LONGER DRIVE COMFORTABLY AFTER DUSK. THE DOCTOR ASSURED PATIENT THAT IT SHOULD IMPROVE, AND THAT WHAT SHE WAS EXPERIENCING WAS ONLY TEMPORARY, AND SAID TO GIVE IT TIME. THE PATIENT DID, AND NOW, TWO YEARS LATER, VISION HAS NOT IMPROVED AND IF ANYTHING HAS GOTTEN WORSE. PATIENT NOW NOTICES/SEES AN AURA AROUND ANYTHING LIGHT OR BRIGHT. THESE HAPPEN WITH BOTH EYES EVEN DURING THE DAY. CAN SEE AURAS AROUND HER COMPUTER, THE TV, HER HAND, HER SILVERWARE AS SHE EATS, THE GLASS OF WATER NEXT TO HER COMPUTER, ETC. AT NIGHT VISION IS SIGNIFICANTLY WORSE AND THE PATIENT CAN NO LONGER DRIVE AFTER DUSK. IT NOW APPEARS THAT THE VISION ISSUE IS NOW PERMANENT. THIS MDR REPORT PERTAINS TO THE RIGHT EYE (OD) OF THE PATIENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE (OS) OF THE PATIENT.
Patient problems: Flashers; Visual Disturbances
MAUDE report 19307311 ↗InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE. THE LENS WAS EXPLANTED AND REPLACED WITH LENS MODEL ZCB00 20.0 DIOPTER. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Eye Injury
MAUDE report 18447307 ↗InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED AFTER AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S OPERATIVE EYE, THERE WAS POSTERIOR CAPSULE RUPTURE. THE IOL WAS EXPLANTED DURING THE SAME PROCEDURE, NO INFORMATION ON THE REPLACEMENT LENS WAS PROVIDED. THE IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Capsular Bag Tear
MAUDE report 17303707 ↗InjuryMay 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTH CARE PROVIDER REPORTED THEY EXPLANTED AN INTRAOCULAR LENS (IOL) DUE TO PATIENT EXPERIENCING BLURRY VISION. THE ISSUE WAS FIRST IDENTIFIED DURING A POST-OP VISIT. AN UNPLANNED VITRECTOMY WAS PERFORMED. THERE WAS NO INCISION ENLARGEMENT AND NO SUTURES REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision
MAUDE report 14465195 ↗InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD INTRAOCULAR LENSES (IOLS) IMPLANTED SEVERAL YEARS AGO IN BOTH EYES. THE PATIENT RETURNED TO THE DOCTOR SIX MONTHS AFTER THE INITIAL SURGERY WITH A COMPLAINT THAT THE VISION WAS NOT GOOD. THE DOCTOR INFORMED THE PATIENT THAT THERE WAS A "GROWTH" AND THE DOCTOR "CUT THE GROWTH OUT WITH A LASER." THE PATIENT WAS TOLD BY THE DOCTOR THAT GLASSES WOULD BE NEEDED TO SEE. THE PATIENT WAS TOLD THAT AN IOL EXCHANGE WAS NOT POSSIBLE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE LEFT EYE EVENT. A SEPARATE REPORT IS BEING FILED FOR THE RIGHT EYE EVENT.
Patient problems: Blurred Vision; Insufficient Information
MAUDE report 14247047 ↗InjuryAug 4, 2021Adverse 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 TO VISUAL ISSUES OF GLARES AND HALOS. THE SYMPTOMS WERE NOTICED RIGHT AFTER SURGERY. THE SUSPECT IOL HAS BEEN DISCARDED. THE REPLACEMENT LENS WAS ANOTHER JOHNSON AND JOHNSON IOL OF DIFFERENT MODEL AND DIOPTER. THERE WAS NO OTHER MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT OUTCOME WAS EXCELLENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Halo; Visual Disturbances
MAUDE report 12277986 ↗InjuryJun 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RECEIVED REPORT INDICATING THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE, HOWEVER, THE PATIENT ENDED UP -1.25D, AND AN EXPLANT WAS FORECASTED. THROUGH FOLLOW-UP IT WAS LEARNED THE IOL WAS EXPLANTED, AND THE INCISION WAS SLIGHTLY ENLARGED. THE EXPLANTED IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS HAPPY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 12029719 ↗InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS INITIALLY REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO PATIENT NOT DOING WELL WITH THE IOL. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THROUGH FOLLOW-UP, IT WAS LEARNED THE PATIENT COMPLAINED OF BLURRED, POOR QUALITY VISION. THE SURGERY WAS COMPLETED USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: Blurred Vision
MAUDE report 11402758 ↗InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS EXPLANTED FROM LEFT EYE DUE TO PATIENT STATING THAT SHE CANNOT SEE FAR IN HER LEFT EYE BUT CAN SEE CLOSE. POST-OP REFRACTION -1.50. THE LENS WAS EXPLANTED AND REPLACED WITH A SAME MODEL LENS, BUT LOWER DIOPTER POWER, 18.5. THERE WERE NO ADDITIONAL SURGICAL/ MEDICAL INTERVENTION REQUIRED, NO INJURY. NO PRESCRIPTION WAS GIVEN TO THE PATIENT OUTSIDE OF THE NORMAL POST-OPERATIVE TREATMENT. DISTANCE VISION IS IMPROVING, NEAR VISION IS NOT GOOD. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Code Available
MAUDE report 10933206 ↗InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2020. THE LENS WAS EXPLANTED (B)(6) 2020 DUE TO COMPLAINTS OF PATIENT HAD RESIDUAL PRESCRIPTION AND NEEDS DIFFERENT POWER AND REPLACED WITH A SAME MODEL IOL WITH A LOWER DIOPTER. AT EXPLANT THE INCISION WAS ENLARGED AND SUTURE(S) WERE REQUIRED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO SERIOUS PATIENT INJURY AND NO UNPLANNED VITRECTOMY. OUTCOME POST-LENS EXCHANGE WAS REPORTED AS: GOOD VISUAL OUTCOME. IT WAS ALSO REPORTED THE EXPLANTED LENS WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 10274436 ↗InjuryJun 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS INITIALLY REPORTED THAT A PATIENT WAS EXPERIENCING BLURRY VISION IN DISTANCE, CAN ONLY READ CLOSE UP AND CANNOT DRIVE AT NIGHT WITH AN INTRAOCULAR LENS (IOL). THE PATIENT HAD SPOKEN TO HIS SURGEON AND WAS TOLD TO GIVE IT A LITTLE MORE TIME. THROUGH FOLLOW-UP, THE PATIENT STATED HE CAN READ THE COMPUTER SCREEN, PHONE, AND SMALL PRINTS JUST FINE, HOWEVER, HIS DISTANCE VISION IS STILL BLURRY. HE CAN'T SEE STREET SIGNS AS WELL, HE SEES STARBURSTS AT NIGHT, AND TRIES TO AVOID DRIVING AT NIGHT. THE PATIENT ALSO MENTIONED HE SAW A BLACK DOT IN HIS RIGHT EYE WHILE LOOKING AT THE COMPUTER SCREEN. THE PATIENT STATED HE IS LOOKING FOR A SECOND OPINION DOCTOR. FURTHER INFORMATION WAS RECEIVED THAT THE PATIENT IS STILL EXPERIENCING BLURRINESS WHEN THERE IS AN OVERCAST AND SEE'S STARBURSTS DURING NIGHT DRIVING AND UNDER CERTAIN LIGHTING CONDITIONS, 5 MONTHS POST-OPERATIVE. THE PATIENT REPORTED SEEING STARBURSTS WITH CEILING LIGHTS. AT THIS TIME, THE LENS REMAINS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 10176895 ↗InjuryApr 21, 2020Adverse 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 PATIENT LEFT EYE DUE TO DYSPHOTOPSIA. THERE WAS NO PATIENT INJURY. PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE DIFFERENT MODEL AND DIOPTER. SUTURES WAS REMOVED AS PART OF SURGICAL INTERVENTION. PATIENT IS DOING WELL POST-OP. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Code Available; Visual Disturbances
MAUDE report 9982461 ↗InjuryJan 13, 2020Adverse 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 PATIENT LEFT EYE DUE TO RESIDUAL MYOPIA. THERE IS NO PATIENT INJURY, NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Code Available
MAUDE report 9583786 ↗InjuryJan 8, 2020Adverse 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 IN THE PATIENT'S RIGHT EYE ON (B)(6) 2019. LENS WAS LATER EXPLANTED DUE TO UNEXPECTED POST-OP REFRACTION WITH MEASUREMENT +.50 -3.25 X105. AT ONE DAY POST-OPERATIVE, THE LENS WAS IN GOOD POSITION; HOWEVER, SIGN OF CORNEAL EDEMA WAS OBSERVED. VISUAL ACUITY WAS CLOUDY. THE REPLACEMENT LENS IS ZXT375 20.0 DIOPTER. NO WOUND ENLARGEMENT OR COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Clouding, Central Corneal; No Code Available; Visual Impairment
MAUDE report 9562186 ↗InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS A POWER MISS WITH A MODEL ZXR00 INTRAOCULAR LENS (IOL). THE LENS WAS EXPLANTED AND REPLACED WITH THE SAME MODEL, BUT HIGHER DIOPTER (22.0). NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: No Code Available; Visual Impairment
MAUDE report 9541890 ↗InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZXR00 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO MYOPIA. THE PATIENT IS NOT BOTHERED BY ANY DYSPHOTOPSIA AND LOVES HER FIRST EYE SURGERY WITH A THE SYMFONY LENS. BUT THIS EYE TURNED OUT PLANO RESULTING IN THE PATIENT BEING TOO MYOPIC WITH -1.00 + 0.25 CYLINDER = 20/20. THEREFORE, THE DOCTOR DECIDED TO EXPLANT THE IOL TO IMPROVE THE DISTANCE VISION. THE EXPLANTED LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER 19.0. REPORTEDLY, THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 9539940 ↗InjuryDec 10, 2019Adverse 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 LEFT EYE DUE TO ASTHENOPIA. THE EXPLANTED LENS WAS DISCARDED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. ANOTHER LENS (SAME MODEL AND DIFFERENT DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WERE NO ISSUES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: No Code Available
MAUDE report 9442908 ↗InjuryDec 6, 2019Unintended Movement; Unintended Movement
IT WAS REPORTED THAT AN WHEN AN INTRAOCULAR LENS (IOL) WAS IMPLANTED, A CAPSULAR TEAR WAS PRESENT. THE LENS WAS LEFT IN THE EYE. THE LENS BECAME DISPLACED AND EXCHANGED SEVERAL DAYS LATER AT BY A DIFFERENT SURGEON WITH A NON-JOHNSON AND JOHNSON IOL. THERE WAS AN INCISION ENLARGEMENT, SUTURES AND VITRECTOMY PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy
MAUDE report 9434121 ↗InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZXR00 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT (OS) OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2019, DUE TO THE PATIENT EXPERIENCING VISUAL ISSUES. THE LENS WAS CUT INTO PIECES AND DISCARDED. THE REPLACEMENT IOL IS A ZLB00 20.0 DIOPTER. THERE WAS NO INDICATION OF INCISION ENLARGEMENT OR SUTURE USED DURING THE SECONDARY PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available; Visual Disturbances
MAUDE report 9282759 ↗InjuryNov 1, 2019Adverse 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 TO THE PATIENT EXPERIENCING PAIN. THE PATIENT COULD NOT DIFFERENTIATE WHAT KIND OF PAIN. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. ANOTHER LENS (DIFFERENT MODEL AND SAME DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING WELL POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: No Code Available; Pain
MAUDE report 9269446 ↗InjurySep 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZXR00 20.0 DIOPTER LENS WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO THEM EXPERIENCING POOR VISUAL ACUITY REFRACTION FOR DISTANCE AND NEAR WAS 20/50. THE LENS WAS REPLACED WITH A LENS OF THE SAME MODEL BUT A 21.5 DIOPTER. REPORTEDLY, THE PATIENT IS DOING FINE NOW. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 9101408 ↗InjuryAug 14, 2019No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available; No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A MECHANICAL FAILURE, THEREFORE, THE LENS WAS EXPLANTED AND REMOVED IN 1 PIECE. AN INCISION ENLARGEMENT WAS REQUIRED. THERE WAS NO OTHER PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: Blurred Vision; No Code Available
MAUDE report 8891639 ↗InjuryJul 1, 2019Break; Break
WHEN INSERTING ZXR00 20.0 DIOPTER INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OCULAR SINISTER (LEFT EYE), CUSTOMER ACCOUNT REPORTED THE HAPTIC BROKE WHILE INSERTING THE LENS. IT WAS REPORTED THERE WAS AN INCISION ENLARGEMENT, SUTURE(S) WERE REQUIRED, THE PROCEDURE WAS COMPLETED USING ZXR00 20.0 DIOPTER BACK-UP LENS, PATIENT OUTCOME WAS REPORTED AS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: No Code Available
MAUDE report 8749286 ↗InjuryJun 19, 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+20.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING INADEQUATE NEAR VISION. SUTURES WERE USED. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT THERE WAS NO CONTRIBUTING MEDICAL HISTORY AND THERE WAS NO CAPSULAR TEAR. PER SURGEON NO INCISION ENLARGEMENT WAS PERFORMED. REPORTEDLY LENS WITH MODEL ZLB00 AND SAME DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. PATIENT WAS DOING VERY GOOD WITH NEAR VISION. VISUAL ACUITY PRE-OPERATIVE: 20/20 DISTANCE NEAR J10; VISUAL ACUITY POST-OPERATIVE: 20/35 DISTANCE NEAR J3. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Code Available; Visual Impairment
MAUDE report 8713912 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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