TECNIS IOL ZXR00 (REF ZXR00U0210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 05050474579118), received between Dec 19, 2016 and Apr 2, 2025 — classified as 100 injuries, 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 101 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE DOCTOR THAT THE LENS WAS EXPLANTED DUE TO A RESIDUAL CYLINDER ERROR. THE PATIENT HAS THIS LENS IN ONE EYE AND AN ODYSSEY LENS IN THE OTHER. THE PATIENT FEELS THE DISTANCE VISION IN BOTH EYES IS GOOD, BUT THE NEAR VISION IS BETTER IN THE EYE WITH THE ODYSSEY LENS, LEADING THE PATIENT TO DESIRE THE SAME LENS IN THE OTHER EYE. THE ORIGINAL LENS WAS IMPLANTED IN 2017 AND THE SURGEON BELIEVED THAT THE NEW ODYSSEY LENS WOULD BETTER SUIT THE PATIENT'S NEEDS. IT WAS REMOVED AND REPLACED WITH A DRT150 LENS WITH A POWER OF 21.5 D. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 21755425 ↗
• 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 ZXR00 19.0 DIOPTER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 18416690 ↗
• MalfunctionJun 16, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) FELL OUT OF CARTRIDGE AND WOULD NOT ADVANCE. IT IS UNKNOWN IF THERE WAS ANY PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144334 ↗
• InjuryApr 24, 2023Adverse 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 A PATIENT¿S RIGHT EYE DUE TO HALOS AND UNACCEPTABLE VISION. THAT DESPITE VERY GOOD SURGICAL OUTCOME, VISUAL ACUITY, GOOD UNCORRECTED VISUAL ACUITY (UCVA) DISTANCE & NEAR AND GIVING ADAPTATION TIME, THE PATIENT WAS NOT ABLE TO TOLERATE GLARE/HALOS ESPECIALLY DURING NIGHT, SEES ARTIFACTS BOTH DAY & NIGHT AND INSISTED ON IOL EXCHANGE. BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) PRE-OP: 20/20 - POST-OP: 20/20. A REPLACEMENT LENS OF DIFFERENT MODEL AND DIOPTER (DIB00 +21.5 D) WAS USED. UNPLANNED SUTURES WERE USED, BUT NO INCISION ENLARGEMENT AND NO VITRECTOMY WERE REQUIRED. IT WAS INDICATED THAT THERE WERE NO COMPLICATIONS AND THAT THE PATIENT IS DOING WELL. ON (B)(6) 2023, WITHOUT CORRECTION (SC): 20/60, PINHOLE (PH): 20/40, BEST CORRECTED VISUAL ACUITY (BCVA): 20/20. WITHIN TWO WEEKS OF IOL EXCHANGE, NEW PERIPHERAL HEMORRHAGE IN RIGHT EYE WAS OBSERVED THROUGH DILATION LIKELY CAUSING VISUAL DISTURBANCE. THE PATIENT WAS REFERRED TO RETINAL SPECIALIST FOR FOCAL VITREOUS HEMORRHAGE AND POSSIBLE SMALL TEAR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16797588 ↗
• InjuryJan 20, 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 PATIENT'S RIGHT EYE AS THE PATIENT COMPLAINED OF GLARE. ANOTHER LENS OF DIFFERENT MODEL AND DIOPTER (Z9002 20.0D) WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY, AND NO OTHER MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. THE PATIENT WAS DOING FINE POST-OPERATION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 13308618 ↗
• InjuryDec 9, 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 SYMPTOMS OF SEVERE GHOSTING. IT WAS NOTED THAT DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. PRE-OP VISUAL ACUITY (VA) 20/40 POST-OP VA 20/40. THE SUSPECT IOL WAS REPLACED WITH A DIFFERENT MODEL (ZLBOO) IOL, 21.5D POWER, SERIAL NUMBER: (B)(4). THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES DONE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 12973413 ↗
• InjuryMar 25, 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 DUE TO PATIENT BEING UNHAPPY AND WANTED A BETTER DISTANCE VISION. THE SUSPECT IOL WAS REPLACED WITH A DIFFERENT IOL MODEL ZA9003, BUT THE SAME DIOPTER POWER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES DONE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 11566887 ↗
• InjuryFeb 24, 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 RIGHT EYE (OD) OF THE PATIENT, DUE TO DISABLING STARBURSTS SINCE DAY 1 POST-IMPLANT. THE EXPLANTED LENS WAS REPLACED WITH A DIFFERENT MODEL IOL (ZKB00). FOLLOW-UP CONFIRMED AT EXPLANT THERE WAS SLIGHT INCISION ENLARGEMENT, NO SCLERAL SUTURES, VITRECTOMY WAS CONCOMITANTLY DONE FOR AN UNRELATED REASON (I.E. FLOATERS). NO INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers

  MAUDE report 11376880 ↗
• InjuryFeb 3, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT RIGHT EYE DUE TO MIS-POWERED LENS IMPLANTATION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11277046 ↗
• InjuryDec 31, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE DUE TO MECHANICAL ISSUE. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED AND THE PATIENT OUTCOME POST SURGERY WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 11102029 ↗
• InjuryNov 9, 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. IT WAS STATED THAT THE EXCHANGE WAS DUE TO A CYLINDER POWER MISS. THE SUSPECT IOL WAS DISCARDED. IT WAS REPLACED THAT LENS WITH ZXT150 21.0D SERIAL NUMBER: (B)(4). THERE WAS NO ADDITIONAL SURGICAL INTERVENTION OR SUTURES REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10814011 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS BEEN HAVING VISUAL ISSUES FROM DAY 1 RIGHT AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN HIS LEFT EYE. THE PATIENT REPORTED NOT BEING ABLE TO SEE CLEAR, HAD DOUBLE VISION WHEN READING AND WITH DISTANCE VISION, AND EXPERIENCED GLARE ISSUES. THE SURGEON PERFORMED LASIK IN (B)(6) 2019 TO HELP IMPROVE WITH VISION, HOWEVER, THE PATIENT REPORTED THERE WAS NO IMPROVEMENT WITH HIS VISION. IN (B)(6) 2019, THE PATIENT WAS GIVEN PRESCRIPTION GLASSES AND STILL HAD NO IMPROVEMENT WITH HIS VISION. THEREFORE, THE LENS WAS EXPLANTED AND REPLACED USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. THE PATIENT HAS RECOVERED AND IS HAPPY WITH HIS VISION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10131358 ↗
• InjuryMay 4, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT'S OPERATIVE EYE BECAUSE OF PATIENT EXPERIENCING SUBLUXATION OF LENS. LENS FROM ANOTHER MANUFACTURER WAS USED AS REPLACEMENT FOR THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Sunset Syndrome

  MAUDE report 10022849 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DYSPHOTOPSIA AND ANISOMETROPIA WITH INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. THE LENS WAS EXPLANTED AND REPLACED WITH A SAME MODEL LENS BUT LOWER DIOPTER (18.5). NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9942059 ↗
• InjuryApr 2, 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) 2020. IT WAS LATER EXPLANTED ON (B)(6) 2020 DUE TO REFRACTIVE MISS. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT HIGHER DIOPTER (22.5). AT EXCHANGE, THERE WAS NO INCISION ENLARGEMENT AND NO INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9919184 ↗
• InjuryMar 30, 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 IN SECONDARY SURGICAL PROCEDURE TO PROVIDE CORRECT POWER TO PATIENT. THE REPLACEMENT LENS IS A MODEL ZLB00, 21.5 DIOPTER. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9901936 ↗
• InjuryMar 4, 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) 21.5 DIOPTER WAS EXPLANTED DUE TO THE PATIENT BEING UNHAPPY WITH THEIR NEAR VISION. THEY EXPERIENCED SEVERE DYSPHOTOPSIA WITH SPIDER WEBS, GLARE AND STARBURSTS. THERE WERE NO COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT OR SUTURE REQUIRED. REPORTEDLY, THE PATIENT IS DOING BETTER. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 9784413 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A ZXR00 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER-OS (LEFT EYE) ON (B)(6) 2018. PATIENT REPORTS COMPLAINTS OF POOR DISTANCE VISION AND FEELS VISION IS WORSE THAN BEFORE SURGERY. (B)(6) 2019 OS POST-OP REFRACTION WAS -75+75@10. PATIENT HAS DRY EYE BUT IS USING PUNCTUM PLUGS AND HAS HAD CORNEAL TREATMENT WITHOUT IMPROVEMENT. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION STATING THERE WERE NO DRY EYE ISSUES. WHEN THE PATIENT WAS NOT SATISFIED WITH VISION, THE DOCTOR TREATED FOR DRY EYE IN THE ABSENCE OF CLINICAL SIGNS OR SYMPTOMS WITH LUBRICANT EYE DROPS AND ANTI-INFLAMMATORY EYE DROPS AND PUNCTUAL PLUGS WITH NO IMPROVEMENT IN SUBJECTIVE VISUAL QUALITY PER PATIENT. ALSO COMPLETED LASER CAPSULOTOMY BOTH EYES FOR MINIMAL POSTERIOR CAPSULAR OPACIFICATION (PCO). NO IMPROVEMENT IN SUBJECTIVE VISUAL QUALITY PER PATIENT. THIS REPORT CAPTURES THE IOL IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). A SEPARATE REPORT WILL BE FILED FOR THE PATIENT'S OCULAR DEXTER-OD (RIGHT EYE). NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; Dry Eye(s); No Code Available

  MAUDE report 9760803 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT WHO HAD BILATERAL SYMFONY LENS IMPLANTS REPORTED OF EXPERIENCING VISUAL ISSUES. THE PATIENT INDICATED THAT HE CANNOT SEE THE COMPUTER OR TELEVISION WELL, BUT HE CAN SEE CLOSE 3-4 FEET. THE PATIENT ALSO MENTIONED THAT AT TIMES HE SEEMS TO HAVE DOUBLE VISION WHERE ONE IMAGE IS ON TOP OF THE OTHER AND WITH REGARDS TO DISTANCE VISION, AT ABOUT 15 FEET HIS VISION IS BLURRY. RIGHT AFTER IMPLANT OF THE LEFT EYE (OS), THE PATIENT EXPERIENCED BLURRY VISION WITH CLOSE/NEAR AND DISTANCE. REPORTEDLY, THE MID-RANGE WAS GOOD. THE PATIENT WAS TOLD HE HAD SOME WRINKLING IN THE LEFT EYE WHICH THEY COULD ADDRESS IT WITH A LASER TREATMENT, BUT AT THE LATER FOLLOW-UP VISIT, HE WAS TOLD THAT THE WRINKLES WERE NO LONGER THERE. THE PATIENT WAS ALSO TOLD THAT ONCE HE HAD HIS RIGHT EYE IMPLANTED, VISION WOULD IMPROVE WITH THE TWO EYES TOGETHER. AFTER THE PATIENT'S RIGHT EYE WAS IMPLANTED, WITHIN A WEEK THE PATIENT BEGAN SEEING THE DOUBLE VISION IMAGES, AND ANYTHING PAST THREE FEET IS BLURRY. THE PATIENT INDICATED THAT THERE ARE TIMES WHEN HIS VISION IS GREAT AND THERE IS NO ISSUE. THE PATIENT'S OPHTHALMOLOGIST SAID THAT IF HE CAN PERFORM A TENDON SURGERY THAT COULD POSSIBLY HELP THE PATIENT

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9754397 ↗
• InjuryFeb 19, 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 RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT NOT BEING HAPPY WITH VISUAL OUTCOME AND EXPERIENCING NIGHTTIME DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT NO SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES WERE REQUIRED AT EXPLANT/EXCHANGE. THE REPLACEMENT LENS USED IS A ZKB00 21.0 DIOPTER LENS. THE PATIENT WAS STABLE AT THE TIME OF DISCHARGE. VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): 20/20, VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT): 20/20, VISUAL ACUITY POST-OP (POST-REPLACEMENT): FIRST POST-OP DAY WAS 20/25. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9729835 ↗
• InjuryJan 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL STUDY SUBJECT HAD TECNIS SYMFONY INTRAOCULAR LENS (IOL) BILATERAL IMPLANTS. A MODEL ZXR00 LENS WAS IMPLANTED IN THE SUBJECT'S LEFT (OS) EYE ON (B)(6) 2019. AT THE THREE MONTHS VISIT ON (B)(6) 2019, THE SUBJECT REPORTED BEING SLIGHTLY BOTHERED WITH DIFFICULTY DRIVING DUE TO HALOS, STARBURSTS AND GLARE, AND BEING MODERATELY BOTHERED BY LOW LIGHT VISION, CAUSING DIFFICULTY READING. AT THIS VISIT THE PATIENT¿S MONOCULAR BEST CORRECTED VISUAL ACUITY (BCDVA) WAS 20/20 RIGHT EYE (OD) AND 20/32 OS, WITH MILD POSTERIOR CAPSULAR OPACIFICATION (PCO) IN THE OS AND TRACE IN OD. THE SUBJECT ALSO MENTIONED TO THE SURGEON THAT SHE HAS BEEN HAVING THESE SYMPTOMS SINCE SURGERY. HER PRE-OP VISUAL ACUITY WAS: UNCORRECTED DISTANCE VISION (UCDV) 20/25 OS, BEST CORRECTED DISTANCE VISION (BCDV) 20/15 OS. THE SUBJECT RETURNED FOR A 4-MONTH STUDY VISIT ON (B)(6) 2019, AND REPORTED THE FOLLOWING SYMPTOMS: SLIGHTLY BOTHERED BY HALOS CAUSING DIFFICULTY WITH DRIVING; MODERATELY BOTHERED WITH STARBURSTS CAUSING DIFFICULTY WITH DRIVING; VERY BOTHERED WITH MULTIPLE/DOUBLE VISION CAUSING DIFFICULTY WATCHING TELEVISION; VERY BOTHERED BY GLARE CAUSING DIFFICULTY DRIVING; AND MODERATELY

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 9604682 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INTRAOCULAR LENS (IOL) MODEL ZXR00 21.0 DIOPTER, WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE ON (B)(6) 2019. THE IOL WAS EXPLANTED ON (B)(6) 2019. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9550314 ↗
• InjuryNov 1, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A MODEL ZXR00 , 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE, AND THE PATIENT¿S POSTERIOR CAPSULE TORE. AN ANTERIOR VITRECTOMY WAS PERFORMED AND SUTURES WERE REQUIRED. THE CUSTOMER REPORTED THAT THE IOL KEPT TILTING BACKWARDS SO THE DOCTOR USED SUTURES, NOT SUTURES AROUND THE EYE, BUT SUTURES WERE USED AROUND THE HAPTIC. SOME OF THE CATARACT WENT TO THE BACK OF THE EYE DURING SURGERY. THERE WERE NO OTHER PATIENT INJURIES REPORTED. THE PATIENT WENT TO A RETINA SPECIALIST THE NEXT DAY. THE LENS WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON & JOHNSON (J&J) LENS. THERE WAS NO LOSS OF TWO (2) OR MORE LINES BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA), AND NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. REPORTEDLY, THE CURRENT STATUS OF THE PATIENT IS WITH A NON-J&J LENS IS THE PATIENT HAS CORNEAL EDEMA, AND A BIT OF BLURRY VISION, BUT HE HAS A GOOD PROGNOSIS. DOCTOR WILL REMOVE THE CATARACT FRAGMENTS LEFT FROM THE INITIAL SURGERY AT A LATER TIME. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Edema; Vitrectomy

  MAUDE report 9269563 ↗
• InjuryOct 24, 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 EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO THE PATIENT EXPERIENCING DYSPHOTOPSIA. THE LENS WAS REPLACED WITH A MODEL ZCB00 IOL OF THE SAME DIOPTER SIZE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 9236631 ↗
• InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 21.0 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 UNSPECIFIED INJURY. NO COMPLICATIONS HAVE BEEN REPORTED POST OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9159414 ↗