TECNIS IOL ZXR00 (REF ZXR00U0195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 05050474579088), received between Feb 8, 2017 and May 23, 2024 — classified as 60 injuries, 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE. THE DOCTOR STATED THIS IS A ¿GREAT CASE! THE IOL IS WELL CENTERED. HOWEVER, THE PATIENT COMPLAINED OF BLURRY VISION AND TROUBLE DRIVING AT NIGHT, BOTHERED BY GLARE FROM CAR HEADLIGHTS. THE PATIENT¿S PRE-OP DILATION WAS REPORTED AS BORDERLINE POOR. THEIR PRE-OP REFRACTION WAS PLANO TO 0.25 X 110, 20/30 -1. POST-OP RESULTS -175 SPHERE. 20/60. THE IOL WAS SUBSEQUENTLY EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19378841 ↗
• InjuryApr 15, 2022Adverse 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 BLURRY VISION. VISUAL ACUITY PRE-OP 20/50, VISUAL ACUITY POST-OP 20/40 +1, 1 DAY POST-OP. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES PERFORMED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 14116663 ↗
• InjuryNov 2, 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 OPERATIVE EYE. THE IOL WAS EXPLANTED IN A SEPARATE SECONDARY PROCEDURE AND REPLACED WITH DIFFERENT MODEL LENS WITH THE SAME DIOPTER SIZE, DIB00 19.5 DIOPTER IOL, DUE TO COMPLAINTS OF MECHANICAL COMPLICATION - REFRACTIVE SURPRISE. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTION. PATIENT WAS REPORTED AS DOING FINE POST-OPERATIVELY. THE LENS IS NOT BEING RETURNED AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 12741837 ↗
• InjuryOct 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 PATIENT'S RIGHT EYE DUE TO UNBEARABLE HALOS AND GLARE. THE LENS WAS DISCARDED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (DIB00 MODEL AND LOWER DIOPTER, 19.0) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT'S POST-OPERATIVE OUTCOME WAS NOT AVAILABLE. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE REPLACEMENT LENS WAS SUCCESSFUL WITH RESOLUTION OF SYMPTOMS AND SATISFACTION WITH VISION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12686777 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLURRY VISION AND COULD SEE THE RINGS ON THE INTRAOCULAR LENS (IOL). THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12200501 ↗
• InjuryFeb 4, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A ZXR00 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S EYE IN A SECONDARY SURGICAL PROCEDURE. ADDITIONAL DETAILS RECEIVED STATED THAT THE LENS WAS DISLOCATED AND PATIENT HAD BLURRED VISION. PATIENT DID NOT HAVE ANY PREVIOUS EYE CONDITIONS. THE REPLACEMENT LENS USED IS A DIFFERENT MODEL, ZMA00, BUT SAME DIOPTER LENS. PATIENT REPORTED NO ISSUES SINCE IMPLANTATION OF REPLACEMENT LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 11277406 ↗
• InjuryDec 28, 2020Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT A CUSTOMER RECENTLY EXPLANTED A SYMFONY LENS AND REPLACED IT WITH A MODEL AR40 INTRAOCULAR LENS (IOL), 19.0 DIOPTER POWER. THERE WAS NO COMPLICATION FROM THE EXCHANGE, AND A SUTURE WAS NOT USED. THE PATIENT IS DOING WELL POST EXCHANGE. THE REASON FOR THE EXCHANGE WAS DUE TO A FILM THAT FORMED ON THE FRONT SURFACE OF THE LENS, SOMETIME AFTER THE PATIENT UNDERWENT A RETINA PROCEDURE, WHICH WAS A GOOD BIT AFTER THE ORIGINAL CATARACT SURGERY. THE DOCTOR BELIEVES THAT THE FILM IS LIKELY THE RESULT OF A COMBINATION OF THE BLOOD AND AIR/GAS THAT WAS USED DURING THE RETINA PROCEDURE. PATIENT IS REPORTED TO BE DOING WELL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 11085038 ↗
• InjuryOct 26, 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 RIGHT EYE DUE TO VISION BEING BLURRED, IMAGES WERE NOT SHARP AND HAD GHOSTING SHADOWS AROUND IMAGES. THERE WAS NO SUTURE OR VITRECTOMY BUT HAD INCISION ENLARGEMENT PERFORMED. THERE WAS NO PRESCRIPTION GIVEN TO THE PATIENT OUTSIDE OF THE NORMAL POST-OPERATIVE TREATMENT. NO FURTHER INFORMATION IS PROVIDED.

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

  MAUDE report 10737865 ↗
• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING GLARE, HALOS AROUND LIGHTS AND HEADLIGHTS AT NIGHT AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE. VISUAL ACUITY (VA) PRE-OPERATIVE (OP): 20/20 BOTH EYES (OU), VA POST-OP: 20/20 OU. THE LEFT EYE IS SCHEDULED FOR EXPLANT ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS LEFT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE LENS IN THE RIGHT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 10538743 ↗
• 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 LEFT EYE DUE HYPEROPIC ASTIGMATISM. THIS LENS WAS REPLACED WITH A MODEL ZXT150, 20.5 DIOPTER IOL. NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED. IT WAS STATED THAT NO PRODUCT WILL BE RETURNED. PATIENT OUTCOME, STABLE AND NO VISUAL ISSUES FOR NOW. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10472237 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, A LETTER WAS RECEIVED FROM A FEMALE PATIENT WHO UNDERWENT BILATERAL ZXR00 INTRAOCULAR LENS IMPLANTS. PER THE PATIENT¿S LETTER, CATARACT SURGERY WAS PERFORMED ON THE OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019, FOLLOWED BY CATARACT SURGERY ON (B)(6) 2019, ON THE OCULAR DEXTER (RIGHT EYE), (HOWEVER PER PATIENT IMPLANT CARDS, LEFT EYE WAS IMPLANTED ON (B)(6) 2019 AND THE RIGHT EYE ON (B)(6) 2019). THE PATIENT NOTED HER UNDERSTANDING WAS THAT POST PROCEDURE SHE WOULD NOT NEED GLASSES AND HER VISION WOULD BE GREATLY ENHANCED. SHE STATED SHE NEVER HAD A DISTANCE VISION PROBLEM. HER OPHTHALMOLOGIST ADVISED HER THERE IS A CALMING PERIOD, HOWEVER, AFTER SIX MONTHS THE IMPLANTS HAVE NOT IMPROVED HER VISION AT ALL, AND SHE HAD TO PURCHASE MORE READING GLASSES. SHE CANNOT DRIVE AT NIGHT BECAUSE OF HALOS AND SPIDER WEB EFFECTS AROUND CAR LIGHTS, STREET AND HIGHWAY LIGHTING. WHEN SHE ATTENDED BASEBALL GAMES, SIGHT AND SOUND PERFORMANCES, SHE WOULD HAVE TO RELOCATE DUE TO BRIGHT LIGHTING. THE PATIENT WAS EXAMINED BY AN OPTOMETRIST (OD) WHO PRESCRIBED GLASSES AND ADVISED HER IT WOULD NOT BE A GOOD IDEA TO HAVE THE LENSES REMOVED. SHE DID NOT FILL THE PRESCRIPTION FOR GLASSES. THE PAT

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9649772 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PATIENT WHO UNDERWENT BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS. SHE IS NOW EXPERIENCING GLARE AT NIGHT, HALOS DURING THE DAY, STARBURSTS, AND AROUND THE STARBURST ARE OTHER LINES. FURTHER INFORMATION PROVIDED STATES THAT THE PATIENT FEELS LIKE SOMEONE HAS POURED OIL IN HER EYE. DOCTOR DID AN YTTRIUM-ALUMINUM-GARNET (YAG) PROCEDURE, BUT IT DID NOT HELP. SHE DOES READ AS WELL AS BEFORE, AND FEELS HER EYESIGHT IS WORSE, AND EYES ARE GLASSY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT HAS GLAUCOMA THAT IS UNDER CONTROL. HER PHYSICIAN TOLD HER IT MIGHT TAKE LONGER FOR HER TO ADAPT, BUT IT HAS BEEN 11 MONTHS. SHE CANNOT SIT IN HER KITCHEN BECAUSE THE LIGHTS OVERHEAD CAUSE HER TO SEE HALOS. SHE SEES HALOS WITH LINES AROUND HEADLIGHTS AND TRAFFIC LIGHTS. SHE HAS HAD DRY EYES BEFORE AND AFTER SURGERY. SHE USES PRESERVATIVE FREE DROPS AND REFRESH OPTIVE. SHE WOULD LIKE TO HAVE THE LENSES EXPLANTED. NO ADDITIONAL INFORMATION WAS RECEIVED. THIS MDR IS FOR THE LEFT EYE. A SEPARATE MDR IS BEING SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Glaucoma; Halo; Visual Disturbances

  MAUDE report 9195104 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AT THE SUBJECT'S 6 MONTH VISIT, THE SUBJECT WAS MODERATELY BOTHERED BY HALOS, STARBURSTS, AND GLARE. THE SUBJECT IS NOT DRIVING AT NIGHT. THE SYMPTOMS INTERFERE WITH DAILY ACTIVITIES. HOWEVER, THE INTRAOCULAR LENS (IOL) REMAINS IMPLANTED WITH NO INTERVENTION PLANNED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT CAPTURES THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8938559 ↗
• InjuryAug 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A ZXR00 19.5 DIOPTER LENS WAS EXPLANTED DUE TO THE LENS DID NOT SIT CORRECTLY IN THE PATIENT¿S RIGHT EYE. THE INCISION WAS ENLARGED TO REMOVE THE LENS. NO SUTURES WERE REQUIRED. REPORTEDLY THERE WAS NO EXTRA INJURY TO THE EYE AND THE PATIENT LEFT THE OPERATING ROOM IN GOOD CONDITION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8900075 ↗
• InjuryJul 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A ZXR00 INTRAOCULAR LENS (IOL) IMPLANTED IN HER RIGHT (OD) EYE ON (B)(6) 2018. ABOUT A MONTH POSTOP, PATIENT INFORMED HER SURGEON THAT SHE IS EXTREMELY UNHAPPY AND THAT THE SYMPTOMS OF NO CHANGE IN VISION, ALONG WITH BLURRINESS IN BOTH EYES AT ALL RANGES, INTERFERES WITH HER NORMAL DAILY ACTIVITIES. THERE IS NO PLAN FOR EXPLANT AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAS BILATERAL LENS IMPLANTS. THIS REPORT REPRESENTS THE RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8787569 ↗
• InjuryJul 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A ZXR00 INTRAOCULAR LENS (IOL) IMPLANTED IN HER LEFT (OS) EYE ON (B)(6) 2018. ABOUT A MONTH POSTOP, PATIENT INFORMED HER SURGEON THAT SHE IS EXTREMELY UNHAPPY AND THAT THE SYMPTOMS OF NO CHANGE IN VISION, ALONG WITH BLURRINESS IN BOTH EYES AT ALL RANGES INTERFERE WITH HER NORMAL DAILY ACTIVITIES. THERE IS NO PLAN FOR EXPLANT AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAS BILATERAL LENS IMPLANTS. THIS REPORT REPRESENTS THE LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8787527 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A MODEL ZXR00 INTRAOCULAR LENS (IOL) HAD A REFRACTIVE SURPRISE. PATIENT HAD A PREVIOUS MYOPIC LASIK. THE PATIENT HAD ~ 0.58 DIOPTER OF ASTIGMATISM PRE OP TO THE IOL IMPLANT. A LIMBAL RELAXING INCISION (LRI) WAS PERFORMED. THE LENS WAS CALCULATED USING THE POST REFRACTIVE SURGERY CALCULATOR AND CONFIRMED INTRAOPERATIVELY WITH OCULAR RESPONSE ANALYZER (ORA). THE PATIENT WAS 20/20 POST-OP DAY (POD) 1 AND VERY HAPPY. ON POD 2 PATIENT STATED HIS VISION BEGAN TO CHANGE AND HAD COMPLAINTS THAT EVERYTHING WAS OUT OF FOCUS; THE GLARE AND HALO WAS BAD. AT POST-OP WEEK (POW) 1 HE WAS -0.75 +0.75 X 100 BUT STILL HAD 20/20 VISION WITHOUT CORRECTION. THE LENS WAS EXPLANTED AND REPLACED WITH A SYMFONY TORIC LENS AND THE PATIENT IS DOING MUCH BETTER AND WANTS HIS OTHER EYE DONE NOW. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 8760949 ↗
• InjuryMar 22, 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. THE REPLACEMENT LENS WAS THE SAME MODEL. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY REQUIRED AND THE PATIENT WAS DOING GOOD. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Code Available

  MAUDE report 8445535 ↗
• InjuryMar 8, 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 DUE TO REFRACTIVE ERROR DUE TO ASTIGMATISM THAT PRESENTED AFTER SURGERY NEEDING A TORIC LENS TO CORRECT HIS VISION. NO WOUND ENLARGEMENT AND NO VITRECTOMY WAS PERFORMED. THE PATIENT WAS REPORTED DOING WELL POST-OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8403500 ↗
• InjuryFeb 21, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT PATIENT WAS SCHEDULED FOR AN EXPLANT IN SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT EXPERIENCING BLURRED NEAR VISION, REPORTEDLY THE POWER WAS OFF, AND PATIENT WAS HYPEROPIC. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT PATIENT UNDERWENT EXPLANT ON (B)(6) 2019. TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 19.5 DIOPTER) WAS EXPLANTED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES REQUIRED. REPORTEDLY LENS WITH SAME MODEL BUT HIGHER DIOPTER OF 21.5 WAS USED AS REPLACEMENT FOR THE PATIENT. PATIENT WAS DOING FINE POST-OPERATIVE. THERE WAS NO PATIENT CONTRIBUTING MEDICAL HISTORY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8356831 ↗
• InjuryJan 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS EXPERIENCING BLURRY NEAR VISION DURING POST-OPERATIVE EXAMINATION IN HER RIGHT EYE (OD) WITH IMPLANTED MODEL ZXR00 19.5 DIOPTER IOL (INTRAOCULAR LENS). AS A RESULT, THE LENS WAS EXPLANTED AND REPLACED WITH A MODEL ZXR00 20.5 DIOPTER LENS. IT WAS ALSO NOTED THAT THERE WAS NO ADDITIONAL INJURY TO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8286374 ↗
• InjuryJan 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS UNABLE TO READ AND HAD A BLURRINESS AT A DISTANT AFTER THE IMPLANTATION OF MODEL ZXR00 19.5 DIOPTER INTRAOCULAR LENS (IOL). THE LENS WAS SUBSEQUENTLY EXPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8211189 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 19.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING MECHANICAL COMPLICATIONS, IMPAIRED VISION, DISCOMFORT AND VISUAL DIFFICULTY. A MODEL ZXT150 19.0 DIOPTER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, NO VITRECTOMY REQUIRED. NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 8201961 ↗
• MalfunctionNov 21, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT WHILE OPENING THE CASE IT WAS FOUND THAT THE LENS WAS SCRATCHED. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8096949 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 19.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018. REASON FOR EXPLANT WAS NOT PROVIDED. THE REPLACEMENT LENS WAS THE SAME MODEL BUT A LOWER DIOPTER, 13.0. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8048781 ↗