TECNIS IOL ZXR00 (REF ZXR00U0205)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY ERV 20.5D · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This TECNIS Symfony ERV 20.5D is an extended depth of focus intraocular lens implanted in the eye during cataract surgery. Most of the 73 reports describe patients seeing halos, glare, starbursts and blurred vision after implantation, and in many cases the lens was removed in a second surgery and replaced; a few describe the lens or its haptics tearing, breaking, or failing to unfold. Reports mention 69 injuries and no deaths. 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
- 73
- Deaths reported
- 0
- Injuries reported
- 69
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 05050474579101), received between Dec 5, 2016 and Aug 29, 2025 — classified as 69 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (5 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem56
- Inadequacy of Device Shape and/or Size5
- Appropriate Device Problem Term/Code Not Available4
- Break2
- Scratched Material2
- Device Contamination with Chemical or Other Material1
- Difficult to Fold, Unfold or Collapse1
- Mechanical Problem1
Patient problems
- No Code Available53
- Halo20
- Visual Disturbances20
- Blurred Vision13
- Visual Impairment10
- Flashers3
- No Clinical Signs, Symptoms or Conditions3
- Dry Eye(s)2
Recent adverse event reports
The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.
InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ZXR00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE. POST-OPERATIVELY, THE PATIENT REPORTED COMPLAINTS OF HALO AND GLARE, THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DIU150 IOL. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Halo; Visual Disturbances
MAUDE report 22928223 ↗MalfunctionJul 15, 2025Break; Break
IT WAS REPORTED THAT NON-PRELOADED MULTIFOCAL INTROCULAR LENS HAPTIC WAS TORN OR BROKEN. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22509656 ↗InjuryJun 4, 2025Adverse 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 DUE TO PATIENT HAVING A REFRACTIVE ERROR OF MANIFEST REFRACTION (MR): -1.25 SPHERE 20/20, ORA (OPTIWAVE REFRACTIVE ANALYSIS WAS USED). PATIENT WITH UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) 20/200, NEAR VISUAL ACUITY J1 SANS CORRECTION. THE PATIENT HAD DIFFICULTY READING STREET SIGNS, LOOKING ACROSS THE ROOM, DRIVING. PATIENT DESCRIBED THEIR SYMPTOMS AS BLURRY VISION, UNABLE TO DRIVE A CAR, NOT SEEING CLEARLY ACROSS THE ROOM. VISUAL ACUITY PRE-OPERATIVE: 20/40. THE SUSPECT IOL WAS REPLACED WITH THE SAME MODEL, BUT WITH LOWER THAN 1.5 DIOPTER SIZE POWER. THERE WAS AN INCISION ENLARGEMENT DURING THE EXPLANT. THERE WAS NO SUTURES, VITRECTOMY, AND INJURY TO THE EYE. NO FURTHER INFORMATION PROVIDED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 22144928 ↗InjurySep 27, 2022Adverse 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 LEFT EYE DUE TO SEVERE HALOS, GLARE, AND LACK OF NEAR VISION. A NON-JOHNSON & JOHNSON 3-PIECE IOL WAS IMPLANTED AS REPLACEMENT. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR IF MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT IS STABLE POST-OPERATIVELY WITH THE NEW LENS, WITH A 3+ POSTERIOR CAPSULE OPACIFICATION (PCO). THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Halo; Visual Disturbances
MAUDE report 15494616 ↗InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WAS IMPLANTED BILATERAL IMPLANTS SOMETIME IN (B)(6) 2019. BUT THESE INTRAOCULAR LENSES (IOLS) WERE EXPLANTED DUE TO MECHANICAL FAILURE. IT WAS LEARNED THAT BY MECHANICAL FAILURE, THE CUSTOMER MEANT THAT THE PATIENT HAD DECREASED NEAR VISION AFTER IMPLANT OF THE LENSES AND HE WAS UNABLE TO READ. HE ALSO COMPLAINED OF SIGNIFICANT GLARE WITH NEW LENSES THAT DID NOT IMPROVE OVER TIME. INITIAL PRE-OP VISUAL ACUITY FOR LEFT EYE: UNCORRECTED VISUAL ACUITY LEFT EYE: 20/20 DISTANCE, 20/30 AT NEAR. POST-OP VISUAL ACUITY AFTER IMPLANTING THE ZXR00 LENS: UNCORRECTED: 20/60 DISTANCE, 20/100 NEAR CHECKED ON (B)(6) 2019, MOST RECENT VISUAL ACUITY PRIOR TO EXPLANT WAS 20/50 DISTANCE, 20/50 NEAR. POST-OP VISUAL ACUITY AFTER IMPLANTING THE DFR00V LENS, 20.0 SERIAL NUMBER (B)(4): 1 DAY POST OP 20/50 AT DISTANCE, 20/100 NEAR (PATIENT HAS NOT HAD FURTHER POST OP YET). NO OTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES EVENT FOR LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR EVENT IN RIGHT EYE.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 12708872 ↗InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). PATIENT SEES BUBBLES IN VISION SINCE ORIGINAL SURGERY, THE DOCTOR TRIED REFRACTION, CONTACT LENS USE, AND TEARS WITH NO IMPROVEMENT AFTER ONE (01) YEAR. THE IOL IMPLANTED IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A ANOTHER JOHNSON & JOHNSON LENS DIFFERENT MODEL LENS WITH THE SAME DIOPTER SIZE (DIB00 IOL 20.5 DIOPTER). PRE-OPERATIVE VISUAL ACUITY WAS REPORTED AS 20/30 AND POST-OPERATIVE VISUAL ACUITY WAS 20/25. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS 20/20. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Disturbances
MAUDE report 12661566 ↗InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING COMPLICATIONS SUCH AS SEEING STARBURST, BIG CIRCLES, AND CANNOT DRIVE. THE PATIENT ALSO REPORTED SEEING STRAIGHT LINES ABOVE THE CIRCLES. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: Blurred Vision; Flashers; Halo; Visual Disturbances
MAUDE report 12333723 ↗MalfunctionAug 2, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
IT WAS REPORTED THAT A TECNIS SYMFONY INTRAOCULAR LENS (IOL) WAS FULLY INSERTED BUT WOULD NOT UNFOLD IN THE PATIENT'S LEFT (OS) EYE. THE LENS WAS REMOVED AND REPLACED WITH A BACK UP LENS DURING THE SAME PROCEDURE. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12263815 ↗InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE PATIENT THAT HE IS NOT SATISFIED WITH HIS INTRAOCULAR LENS (IOL) PROCEDURE. HE STATED THAT HE CANNOT DRIVE AT NIGHT ANYMORE, HE FEELS LIKE THERE IS A FOG IN HIS RIGHT EYE, (OD) HE SEES HALOS AND STARBURSTS IN BOTH EYES (OU). FOCUS IS WORSE IN HIS RIGHT THAN LEFT EYE (OS). HE FEELS LIKE HIS VISION IS WORSE THAN BEFORE THE SURGERY. HE GOT A SECOND OPINION, AND ALL THEY SAID WAS HE HAS TO HAVE THEM REPLACED. THE FIRST DOCTOR WHO IMPLANTED THE IOL SAID HE WILL NOT PUT A MULTIFOCAL LENS IN, AND IS GOING TO HAVE A RETINA SPECIALIST COME IN TO IMPLANT A PLAIN LENS, THAT SURGERY WAS SCHEDULED FOR THE (B)(6), BUT IT WAS RESCHEDULED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT TO CAPTURE EVENT FOR OD. A SEPARATE MDR REPORT WILL BE SUBMITTED FOR EVENT IN OS.
Patient problems: Blurred Vision; Flashers; Halo
MAUDE report 11313576 ↗InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE PATIENT THAT HE IS NOT SATISFIED WITH HIS INTRAOCULAR LENS (IOL) PROCEDURE. HE STATED THAT HE CANNOT DRIVE AT NIGHT ANYMORE, HE FEELS LIKE THERE IS A FOG IN HIS RIGHT EYE, (OD) HE SEES HALOS AND STARBURSTS IN BOTH EYES (OU). FOCUS IS WORSE IN HIS RIGHT THAN LEFT EYE (OS). HE FEELS LIKE HIS VISION IS WORSE THAN BEFORE THE SURGERY. HE GOT A SECOND OPINION, AND ALL THEY SAID WAS HE HAS TO HAVE THEM REPLACED. THE FIRST DOCTOR WHO IMPLANTED THE IOL SAID HE WILL NOT PUT A MULTIFOCAL LENS IN, AND IS GOING TO HAVE A RETINA SPECIALIST COME IN TO IMPLANT A PLAIN LENS, THAT SURGERY WAS SCHEDULED FOR THE 19TH, BUT IT WAS RESCHEDULED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES EVENT FOR OS. A SEPARATE REPORT IS SUBMITTED FOR EVENT IN OD.
Patient problems: Blurred Vision; Flashers; Halo
MAUDE report 11313510 ↗MalfunctionJan 26, 2021Scratched Material; Scratched Material
IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) HAD SCRATCH. NOT SURE ABOUT PATIENT CONTACT INFORMATION. THE IOL WAS NOT SAVED SINCE IT WAS ACCIDENTALLY DISPOSED OF IN TRASH AFTER SURGERY. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11233592 ↗InjuryNov 4, 2020Adverse 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) WAS EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE BECAUSE SHE WAS NOT HAPPY WITH FAR VISION. THE REPLACEMENT LENS IS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, PATIENT IS DOING GOOD POST SURGERY. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Code Available; Therapeutic Effects, Unexpected
MAUDE report 10788761 ↗InjurySep 29, 2020Unintended Movement; Unintended Movement
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS PLANNED TO BE EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO THE LENS DISLOCATING. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE LENS WAS REPOSITIONED/RE-CENTERED. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: No Code Available
MAUDE report 10601591 ↗InjuryApr 4, 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 LEFT EYE DUE TO THE PATIENT BEING UNHAPPY WITH NEAR VISION. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: No Code Available; Visual Impairment
MAUDE report 9925763 ↗InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A ZXR00 20.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. IT WAS REPORTED THERE WAS AN INFECTION AFTER THE SURGERY, BUT PRESENTLY, THERE IS NO INFECTION. PATIENT HAS DIFFICULTY DRIVING AT NIGHT DUE TO HALOS. PATIENT HAS BEEN TO HER EYE DOCTOR NUMEROUS TIMES, AND WAS INITIALLY TAKING SEVERAL EYE DROPS; NAMES OF THE EYE DROPS WERE NOT PROVIDED. PATIENT HAS NOT HAD A 2ND OPINION REGARDING THE REPORTED ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. THE PATIENT HAS BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE IOL IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). A SEPARATE REPORT IS BEING SUBMITTED FOR THE PATIENT'S OCULAR DEXTER (RIGHT EYE).
Patient problems: Halo; No Code Available; Unspecified Infection; Visual Impairment
MAUDE report 9703533 ↗InjuryJan 13, 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 (OD) EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED DUE TO RESIDUAL MYOPIA ON (B)(6) 2019. THERE WAS NO PATIENT INJURY. NO SURGICAL INTERVENTIONS: SUCH AS; VITRECTOMY; INCISION ENLARGEMENT; OR SUTURES WERE REQUIRED. THE REPLACEMENT LENS IS A ZXT150 20.0 DIOPTER LENS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 9583826 ↗InjuryDec 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 +20.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE BECAUSE OF PATIENT EXPERIENCING POOR UNCORRECTED VISUAL ACUITY (UCVA). THERE WAS NO VITRECTOMY, NO SUTURES AND NO INCISION ENLARGEMENT REQUIRED. A MODEL ZXT150 WITH LOWER DIOPTER (+18.5) WAS THE REPLACEMENT LENS. REPORTEDLY PATIENT HAD OUTCOME MORE MYOPIC, UNEXPECTED REFRACTIVE RESULT AND ASTIGMATISM THAN EXPECTED. VISUAL ACUITY PRE-OPERATIVE: 20/30.1 20/200. VISUAL ACUITY POST-OPERATIVE ((B)(6) 2019): -2.00 +1.00 X 115 20/20.2 // UCVA 20/40 +1. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Code Available
MAUDE report 9493867 ↗InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZXR00 20.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019, DUE TO AN UNSPECIFIED INJURY. A REPLACEMENT LENS, OF THE SAME MODEL, AND A LOWER DIOPTER (19.0) WAS IMPLANTED. NO COMPLICATIONS HAVE BEEN REPORTED POST OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 9159434 ↗InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZXR00 20.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO AN UNSPECIFIED INJURY. NO COMPLICATIONS HAVE BEEN REPORTED POST OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 9159421 ↗InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISTORTED AND BLURRY VISION. THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: Blurred Vision; No Code Available; Visual Disturbances
MAUDE report 9048646 ↗InjuryAug 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S VISION WAS NOT AS GOOD AS EXPECTED AT POST-OPERATIVE APPOINTMENT. THEREFORE, THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON & JOHNSON LENS. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. AND THERE WAS NO ADDITIONAL INJURY TO THE EYE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: No Code Available; Visual Disturbances
MAUDE report 8849953 ↗InjuryAug 1, 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 EXPLANTED AND REPLACED FROM THE PATIENTS RIGHT EYE DUE TO THE PATIENT REQUIRING A DIOPTER CHANGE. THE REPLACEMENT LENS WAS THE SAME MODEL BUT DIFFERENT DIOPTER. THERE WAS NO ADDITIONAL INTERVENTION PERFORMED AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 8849334 ↗InjuryJul 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED HAVING SLIGHTLY BLURRED VISION AFTER IMPLANT OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. THE PATIENT STATED SHE HAS TO WEAR GLASSES TO SEE ANYTHING UP CLOSE AND INTERMEDIATE AS SHE HAS TROUBLE READING. THE PATIENT ALSO EXPERIENCED SEEING FLOATERS, BUT THEY WENT AWAY. THERE WAS NO PRIOR HISTORY OF FLOATERS BEFORE THE IOL IMPLANT. AFTER 3 MONTHS POST-OPERATIVE, THE PATIENT HAD A LASER PROCEDURE PERFORMED TO REMOVE THE FILM OFF HER EYE. HOWEVER, THE PATIENT CONTINUES TO EXPERIENCE BLURRINESS. AT THIS TIME, THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT REPRESENT THE LENS IMPLANTED IN PATIENTS RIGHT EYE.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 8770027 ↗InjuryMay 23, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A ZXR00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO POOR VISION SECONDARY TO MECHANICAL COMPLICATIONS OF THE DEVICE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES DONE. THE PATIENT IS FINE POST-OP. THE REPLACEMENT LENS WAS A NON-JOHNSON & JOHNSON SURGICAL VISION IOL. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available; Visual Impairment
MAUDE report 8634961 ↗InjuryMay 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IOL MODEL ZXR00 20.5 DIOPTER INTRAOCULAR LENS (IOL) WILL BE EXPLANTED DUE TO THE PATIENT EXPERIENCING TREMENDOUS HALOS AND GLARE. VIA FOLLOW-UP IT WAS CLARIFIED THAT THE PATIENT WAS SEEN IN THE MEDICAL OFFICE WITH THE REPORTED SYMPTOMS ON (B)(6) 2019 AND AGAIN SEEN ON (B)(6) 2019 WITH THE SYMPTOMS NOT IMPROVING. AN EXPLANT IS SCHEDULED FOR (B)(6) 2019. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Halo; No Code Available
MAUDE report 8593300 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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