TECNIS IOL ZLB00 (REF ZLB00U0210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 05050474560697), received between Aug 23, 2016 and Aug 25, 2025 — classified as 43 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 46 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED LENS WAS EXPLANTED DUE TO AN UNKNOWN ISSUE. IT WAS REMOVED AND REPLACED WITH ANOTHER MODEL, J& IOL, DURING A SECONDARY SURGICAL PROCEDURE. NO PATIENT INJURY OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 22891809 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT A JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO HER RIGHT AND LEFT EYE. THE PATIENT REPORTED EXPERIENCING BLURRY VISION AFFECTING ALL RANGES OF VISION, WITH THE ISSUE BEING MORE PRONOUNCED IN THE RIGHT EYE. SHE HAS UNDERGONE A SUBSEQUENT LASIK SURGERY. HER RIGHT EYE WAS IMPLANTED (B)(6) 2022. HOWEVER, THE BLURRINESS BEGAN APPROXIMATELY 2-3 MONTHS AGO FROM THE DATE THIS EVENT WAS REPORTED TO JNJ WHICH IS (B)(6) 2025. REPORTEDLY, THERE WERE NO CHANGES TO HER OVERALL HEALTH DURING THIS TIME. PRIOR TO THE ONSET OF SYMPTOMS, SHE DESCRIBED HER VISION AS EXCELLENT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE LEFT EYE. MANUFACTURER REPORT NUMBER 3012236936-2025-0002059. THE RIGHT EYE IS REPORTED IN MANUFACTURER REPORT NUMBER 3012236936-2025-0002058.

  Patient problems: Blurred Vision

  MAUDE report 22683291 ↗
• InjuryOct 29, 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 EXCHANGED WITH ZLU150, 20.5 DIOPTER, IN A SECONDARY PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 20560038 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DOCTOR REFERRED A FEMALE PATIENT TO ANOTHER DOCTOR TO SEE ABOUT AN YTTRIUM-ALUMINUM-GARNET (YAG) LASER TREATMENT. IT WAS REPORTED THAT THE PATIENT DOES HAVE A TINY BIT OF POSTERIOR CAPSULAR OPACIFICATION (PCO) IN THE RIGHT EYE (OD). THAT THE PATIENT STATED SHE COULD NOT READ ANYTHING IF IT IS LAYING ON HER DESK AND SHE IS LOOKING DOWN AT IT. THAT THE PATIENT HAS TO HOLD IT UP DIRECTLY IN FRONT OF HER TO READ. THE PATIENT REPORTED TO HER DOCTOR THAT WHEN SHE WEARS HER PERSONAL SUNGLASSES, NON-PRESCRIPTION (NON-RX), SHE SEES A "MAZE" ON THE INSIDE OF THE LENSES WITH EACH EYE. THE PATIENT DID NOT SAY SHE SEES RINGS, SHE SAID A MAZE WHICH THE DOCTOR HAD NO IDEA WHAT THAT WOULD BE ABOUT. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT INDICATED THAT EVER SINCE HER CATARACT SURGERIES, THE PATIENT HAS NOT BEEN ABLE TO SEE AND HAS DISCOMFORT. THE PATIENT REPORTED THAT EVERYTHING IS BLURRY, HAS TO LOOK A LITTLE FROM THE SIDE, TILT IN VARIOUS DIRECTIONS, FEELS LIKE HER EYEBALLS & EVERYTHING AROUND THEM ARE SWOLLEN & HAS A FRAME AROUND THEM. THE PATIENT HAS PAIN DAILY IN HER EYES NO MATTER HOW MANY DROPS SHE USES, SHE EXPERIENCES PRESSURE AND FEELING OF A FRAME/RESTRICTION AROUND HER EYE,

  Patient problems: Blurred Vision; Eye Pain; Halo; Visual Disturbances

  MAUDE report 19177917 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE MODEL ZLB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO UNKNOWN REASONS AND REPLACED WITH A ZLB00 23.5 DIOPTER IOL. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 19102367 ↗
• InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT REPORTED THAT HE HAD BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS ON (B)(6) 2019 AND (B)(6) 2019 AND SINCE THEN, THE PATIENT FEELS THAT SOMETHING IS NOT RIGHT. WHEN THE PATIENT FIRST GOT THE PROCEDURE DONE, HIS VISION WAS NOT AS GOOD AS HE EXPECTED, HOWEVER, THE PATIENT IS NOT SEEING AS WELL, AS HE FIRST DID IN 2019. THE PATIENT INDICATED THAT RIGHT AFTER THE SURGERIES, HE STARTED HAVING BLURRY VISION AND RECENTLY HE IS ALSO HAVING FLOATERS AND SPIDER WEBS. THERE ARE MULTIPLE FLOATERS IN HIS LEFT EYE THAT ARE BOTHERSOME. THE PATIENT CANNOT SEE HIS DAILY TOILETRIES AND HE CANNOT SEE WHEN HE SHAVES ANYMORE. THE PATIENT MENTIONED THAT HE HAD VERY DRY EYES, THAT THEY WERE DRY BEFORE BUT MORE SO NOW. THE PATIENT HAS BEEN USING SOME SORT OF LUBRICANT EVERY TWO (2) HOURS AND HAS ALSO BEEN GIVEN RESTASIS EYE DROPS WHICH HE USES TWICE A DAY. THE PATIENT FEELS THAT HIS EYES ARE BETTER WHEN HE USES THE LUBRICANT DROPS. THE PATIENT WAS TOLD HE CAN USE OVER THE COUNTER READERS, BUT SOMETIMES 1.25 DIOPTER (D) WORKS FOR HIM AND SOMETIMES IT DOES NOT WHICH THEN, HE HAS TO USE A DIFFERENT POWER, 1.5 D. THE PATIENT HAS SEEN HIS DOCTOR AS WELL AS ANOTHER DOCTOR AT THE SAME OFFICE FOR A SE

  Patient problems: Blurred Vision; Vitreous Floaters

  MAUDE report 12988676 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO POOR VISION AND DYSPHOTOPSIA. DAILY ACTIVITIES OF THE PATIENT WERE SIGNIFICANTLY AFFECTED. THE REPLACEMENT LENS USED IS A DIFFERENT MODEL SAME DIOPTER LENS. PATIENT HAS FULLY RECOVERED. VISION PRE-OPERATIVE: 20/20. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12389226 ↗
• MalfunctionJun 23, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A CRACK. THE IOL WAS CUT OUT AND REMOVED FROM THE EYE DURING THE SAME PROCEDURE. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS BEING USED AS THE REPLACEMENT LENS, HOWEVER WHILE BEING IMPLANTED THE PATIENT'S CAPSULE BROKE. THROUGH FOLLOW-UP, IT WAS CONFIRMED THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED IN THE PATIENT'S LEFT EYE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE CRACKED IOL. A SEPARATE REPORT IS BEING SUBMITTED FOR THE CAPSULE BREAK EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12047499 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CAPSULE BROKE AS THE INTRAOCULAR LENS (IOL) WAS BEING IMPLANTED IN THE LEFT EYE. THROUGH FOLLOW-UP, IT WAS CONFIRMED THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS Z9002 (DIFFERENT MODEL AND UNKNOWN DIOPTER) WAS IMPLANTED AS A REPLACEMENT LENS. THE PATIENT IS DOING FINE AND IS VERY HAPPY WITH THE OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Capsular Bag Tear

  MAUDE report 12047454 ↗
• InjuryMay 28, 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). POST-IMPLANT THE PATIENT COMPLAINED OF HALOS. THE LENS WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL LENS, ZCB00 WITH THE SAME DIOPTER SIZE. THERE WAS NO DELAY IN PROCEDURE, NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY. THE PATIENT'S PRE-OPERATIVE VISUAL ACUITY WAS REPORTED AS 20/40, AND POST-OPERATIVE VISUAL ACUITY WAS 20/20. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo

  MAUDE report 11903768 ↗
• InjuryJan 10, 2020Break; Break

  IT WAS REPORTED THAT DURING PHACOEMULSIFICATION AND INTRAOCULAR LENS IMPLANTATION, THE HAPTIC OF THE IMPLANTED LENS WAS FOUND BROKEN AND ANOTHER LENS WAS IMMEDIATELY USED AS REPLACEMENT FOR THE PATIENT IN SAME SURGICAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT INCISION WAS ENLARGED DURING THIS PROCEDURE. NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9577484 ↗
• InjuryJan 7, 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 THE PATIENT'S RIGHT EYE DUE TO PATIENT COMPLAINT OF VISION NOT BEING CLEAR, GLARE AT NIGHT AND VISUAL DISTURBANCE. THERE WAS NO PATIENT INJURY BUT A LIMBAL RELAXATION INCISION WAS PERFORMED. THE EXPLANTED LENS WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THE PATIENT OUTCOME WAS EXCELLENT. NO ADDITIONAL INFORMATION WAS RECEIVED.

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

  MAUDE report 9560148 ↗
• InjuryOct 29, 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 DUE TO THE PATIENT EXPERIENCING DYSPHOTOPSIA. 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 FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9251956 ↗
• InjurySep 20, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZLB00 +21.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING MECHANICAL FAILURE. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND NO VITRECTOMY PERFORMED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9096377 ↗
• InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZLB00 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2019. IOL WAS EXPLANTED ON (B)(6) 2019 DUE TO COMPLAINTS OF UNABLE TO TOLERATE POOR INTERMEDIATE VISION. ZLB00 LENS WAS REPLACED WITH ZKB00 LENS. IT WAS REPORTED PATIENT WAS SEEN (B)(6) 2019 AND VISION STILL BLURRY. MONARCH CARTRIDGE WAS USED, ACCOUNT WAS REMINDED JOHNSON & JOHNSON VISION RECOMMENDS ONLY USING JJSV QUALIFIED INSERTIONS SYSTEMS AS INSTRUCTED PER PRODUCT DIRECTIONS FOR USE. 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: Blurred Vision; No Code Available

  MAUDE report 8955156 ↗
• InjuryJul 16, 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 DUE TO A MECHANICAL FAILURE. FURTHER INFORMATION WAS PROVIDED, AND IT WAS LEARNED THAT THE PATIENT HAD A CONSTANT BLUR AT DISTANCE. THE PATIENT DESCRIBED HIS NEAR VISION WITH MONOCULAR GHOSTING OF ALL IMAGES. SPECTACLE CORRECTION DID NOT RESOLVE THE VISUAL SYMPTOMS. AT EXPLANT AN INCISION ENLARGEMENT WAS REQUIRED. THE REPLACEMENT LENS WAS A DIFFERENT MODEL AND DIFFERENT DIOPTER. THE PATIENT IS REPORTED TO BE HEALING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

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

  MAUDE report 8796496 ↗
• InjuryJul 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A ZLB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2019. AT 1 DAY POSTOP, SHE EXPERIENCED HALOS, BLURRED VISION, HEADACHES, IRRITATION, AND DRY EYE. PATIENT IS NOT HAPPY WITH HER EYE DOCTOR AND WENT TO A DIFFERENT DOCTOR WHERE SHE HAS RECEIVED EYE DROPS. SHE REPORTED THAT THE MEDICATIONS WERE INEFFECTIVE IN TREATING HER SYMPTOMS. THERE IS NO PLAN FOR A LENS EXCHANGE AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED. PATIENT HAS BILATERAL IMPLANTS. THIS REPORT REPRESENTS THE LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Dry Eye(s); Headache; Irritation

  MAUDE report 8787354 ↗
• InjuryJun 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED IN ONE PIECE DUE TO MECHANICAL COMPLICATION. AN INCISION ENLARGEMENT WAS PERFORMED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT HAD SIGNIFICANT DIFFICULTY WITH BLURRY VISION. THE PATIENT HAD NO CONTRIBUTING MEDICAL HISTORY. THERE WAS NO VISUAL IMPROVEMENT NOTED WITH THE RECOMMENDED USE OF ARTIFICIAL TEARS OR WITH SPECTACLES. THE EXPLANTED IOL WAS REPLACED WITH A AAB00 IOL AND THE PATIENT IS HEALING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8706208 ↗
• InjuryMay 29, 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 REMOVED AND REPLACED AS THE SURGEON STARTED TO INSERT THE LENS THEN DECIDED TO ENLARGE THE WOUND SLIGHTLY TO ACCOMMODATE THE INJECTOR BETTER. THE DOCTOR WANTED A NEW LENS TO BE LOADED AS THIS ONE WAS ALREADY ADVANCED. AN INCISION ENLARGEMENT WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8648605 ↗
• InjuryMay 15, 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 POOR INTERMEDIATE VISION. THE LENS WAS REPLACED WITH A MODEL ZKB00, 21.0 DIOPTER LENS AND THE PATIENT IS NOW, ONE DAY AND ONE WEEK POST-OP, MUCH HAPPIER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8610745 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) 21.0 DIOPTER WAS IMPLANTED ON (B)(6) 2018, INTO THE PATIENTS RIGHT EYE. THE IOL WAS EXPLANTED ON (B)(6) 2018, AND REPLACED WITH A ZLB00 OF 20.0 DIOPTER. REPORTEDLY, THERE WERE NO PATIENT INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8233811 ↗
• InjuryDec 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2018 AND EXPLANTED ON (B)(6) 2018 DUE TO DYSPHOTOPSIA (SEVERE GLARE/HALO). THERE WAS NO ADDITIONAL INTERVENTION REQUIRED. A ZCB00 21.5 WAS IMPLANTED AS THE REPLACEMENT LENS AND THE SYMPTOMS WERE ALLEVIATED. VISUAL ACUITY IS 20/20. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8200189 ↗
• InjuryNov 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZLB00, +21.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE IN A SECONDARY PROCEDURE BECAUSE OF INABILITY TO CORRECT VISION BETTER THAN 20/40 DESPITE OCULAR PATHOLOGY. LENS WAS REPORTEDLY CENTERED PERFECTLY. THE REPLACEMENT LENS WAS A MODEL ZXR00, +22.5 DIOPTER LENS. PATIENT CAN SEE 20/20 NOW. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8072808 ↗
• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 21.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT WAS UNABLE TO TOLERATE MYOPIA AND BECAUSE OF AN UNEXPECTED POST-OPERATIVE REFRACTION. THE GOAL WAS PLANO, BUT THE PATIENT ENDED UP -2.50. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7669673 ↗
• InjuryJun 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 21.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO AN UNDESIRED MYOPIC OUTCOME BY THE PATIENT. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 19.5. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7577567 ↗