TECNIS IOL ZLB00 (REF ZLB00U0200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 05050474560673), received between Sep 26, 2016 and Nov 19, 2025 — classified as 25 injuries, 1 malfunction.

The most frequently reported specific device problem is “Scratched Material” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ZLB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DUE TO UNKNOWN REASONS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A ZCB00 20.0 IOL. THERE WAS NO PATIENT INJURY; HOWEVER, PATIENT PROGNOSIS POST LENS EXCHANGE IS ALSO UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 23597338 ↗
• InjuryJan 23, 2025Adverse 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 EXPLANTED IN A SECONDARY PROCEDURE. THE PATIENT EXPERIENCED ONGOING SHADOWS. THE ONGOING SHADOWS WERE REPORTED DURING A POST OPERATIVE EXAM. ADDITIONAL MEASUREMENTS WITH MRX (MANIFEST REFRACTION) AND ITRACE (ITRACE IS AN OPHTHALMIC DIAGNOSTIC TOOL) BOTH SHOWED A BENEFIT FROM +0.50 IOL POWER DUE TO THE CAPSULAR TENSION. THE IOL WAS REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL MODEL ZLB00 20.5 DIOPTER. REPORTEDLY, THE DIRECTIONS FOR USE WERE FOLLOWED AND THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury; Visual Disturbances

  MAUDE report 21226432 ↗
• InjuryNov 10, 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 FROM THE PATIENT'S OPERATIVE EYE DUE TO THE PATIENT BEING UNHAPPY WITH THE RESULTS. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO BLURRED VISION AND POOR QUALITY OF VISION. VISUAL ACUITY PRE-OPERATIVE: 20/30 -2 AND VISUAL ACUITY POST-OPERATIVE: 20/40. THE LENS WAS DISCARDED. ANOTHER JOHNSON & JOHNSON LENS, MODEL DIB00 20.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. THE PATIENT POST-OPERATIVELY HEALED WELL AND VISION IS BETTER. NO OTHER INFORMATION AS PROVIDED.

  Patient problems: Blurred Vision; Discomfort

  MAUDE report 15774368 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STARTED TO EXPERIENCE SYMPTOMS SHORTLY AFTER SURGERY IN BOTH EYES (OU) WHEN THE INTRAOCULAR LENSES (IOLS) WERE IMPLANTED. THE PATIENT STATED THAT HER VISION HAS NOT IMPROVED IN EITHER EYE AND THAT SURGERY DID NOT ACHIEVE THE RESULTS SHE WAS LOOKING FOR. THE PATIENT STATED THAT THE SYMPTOMS ARE NOT DEBILITATING AND THAT SHE IS ABLE TO FUNCTION WITH HER OLD GLASSES OR A MAGNIFYING GLASS. THE PATIENT COMPLAINED OF BLURRY VISION AND FILM OU AND PAIN IN HER RIGHT EYE (OD). THE SURGEON DIAGNOSED THE PATIENT WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (AMD) WITH ACTIVE CHOROIDAL NEOVASCULARIZATION (CNV) OD, PARTIAL POSTERIOR VITREOUS DETACHMENT OU, AND POSTERIOR CAPSULAR HAZE OU. THE SURGEON ADDITIONALLY ADMINISTERED A SHOT OF AVASTIN OD. THERE WAS NO REPORTED TREATMENT FOR THE LEFT EYE (OS). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Eye Pain; Macular Edema; Vitreous Detachment

  MAUDE report 14479246 ↗
• InjuryAug 13, 2021Adverse 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 LEFT EYE AS PATIENT COMPLAINED OF EXTREME AND UNBEARABLE GLARE AND HALOS AT NIGHT. ADDITIONAL INFORMATION RECEIVED REVEALS THAT THE ONSET OF SYMPTOMS WAS FROM THE BEGINNING OF THE POST-OPERATIVE COURSE. THE INITIAL CALCULATIONS WERE CORRECT AND PATIENT REPORTED EXCELLENT VISUAL ACUITY OF 20/20 DISTANCE AND J1 NEAR. HOWEVER, THE CONDITION OF UNBEARABLE GLARE AND HALOS AFFECTED PATIENT'S ABILITY TO PERFORM DAILY ACTIVITIES AND SHE COULD NOT DRIVE. A DIFFERENT MODEL ZCB00, BUT SAME DIOPTER LENS WAS IMPLANTED AS THE REPLACEMENT. THE EXPLANTED LENS WAS NOT SAVED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12317348 ↗
• InjuryApr 9, 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 A SECONDARY SURGICAL PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9947067 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) 20.0 DIOPTER WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE AND A ZKB00 20.0 WAS IMPLANTED IN THE LEFT EYE. THE PATIENT IS EXPERIENCING HALOS, BLURRY VISION AND STARBURSTS. PER THE PATIENT, HE WAS TOLD AT THE DOCTOR¿S OFFICE BEFORE THE SURGERIES THAT HE¿D HAVE THE EYESIGHT OF A 20-YEAR OLD. HOWEVER, AFTER SURGERY, PATIENT IS EXPERIENCING HALOS, BLURRED VISION AND STARBURSTS. HE¿S ALSO HAVING DIFFICULTY WHILE DRIVING AT NIGHT. THE SIGN POSTS LOOK TWICE THEIR ACTUAL SIZE. THE PATIENT IS NOT TAKING ANY EYE DROPS. THRU FOLLOW-UP THE PATIENT REPORTED HE HAD FLOATERS PRIOR TO THE IMPLANTS. HE STILL HAS FLOATERS POST IMPLANTS BUT NOW THE FLOATERS ARE WORSE. HE CLARIFIED, HE IS HAVING THE SAME SYMPTOMS IN BOTH EYES. THE LEFT EYE IS JUST WORSE. NO FURTHER INFORMATION WAS PROVIDED. THIS MDR WILL CAPTURE INFORMATION FOR THE RIGHT EYE IOL ZLB00. THE LEFT EYE IS CAPTURED IN A SEPARATE MDR.

  Patient problems: Blurred Vision; Visual Disturbances; Vitreous Floaters

  MAUDE report 9836343 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZLB00 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. THE ZLB00 20.0 DIOPTER LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO COMPLAINT OF REFRACTIVE MISS AND REPLACED WITH A ZMB00 22.0 DIOPTER LENS. IT WAS REPORTED THERE WAS NO PATIENT INJURY AND THE LENS WAS DISCARDED AND IS NOT BEING RETURNED. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING THE PATIENT HAS NO CONTRIBUTING MEDICAL HISTORY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9711866 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZLB00 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. THE ZLB00 20.0 DIOPTER LENS EXPLANTED FROM THE PATIENT¿S OPERATIVE EYE ON (B)(6) 2020 AND REPLACED WITH ANOTHER ZLB00 LENS. ATTEMPTS WERE MADE TO OBTAIN 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; Visual Disturbances; Visual Impairment

  MAUDE report 9709026 ↗
• InjurySep 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD MOVED POST-OPERATIVELY AND THE PATIENT EXPERIENCED BLURRY VISION. THEREFORE, THE LENS WAS EXPLANTED. A VITRECTOMY WAS REQUIRED. REPORTEDLY, THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; No Code Available; Vitrectomy

  MAUDE report 9121199 ↗
• InjuryMay 23, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZLB00 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE OF THE PATIENT DUE BLURRY VISION, POSTOPERATIVE REFRACTIVE ERROR, DUE TO MECHANICAL COMPLICATIONS OF THE IOL. VISUAL ACUITY PRE-OP 20/40 AND THEN POST-OP 20/70. AT EXCHANGE THERE WAS NO VITRECTOMY HOWEVER, THERE AN INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. THE REPLACEMENT LENS WAS ANOTHER ZLB00 OF A LOWER DIOPTER *18.0). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8638840 ↗
• InjuryFeb 22, 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 IMPLANTED ON (B)(6) 2018 INTO THE RIGHT EYE AND THE PATIENT COMPLAINT OF DIFFICULTY READING AND BLURRY VISION. THERE WERE NO ADVERSE PATIENT AFFECTS DURING SURGERY. THE PATIENT REQUESTED A SYMFONY IOL BE IMPLANTED. ADDITIONAL INFORMATION RECEIVED REVEALED THE PATIENT FIRST REPORTED THE VISUAL ISSUES ON (B)(6) 2018, AND THE EXPLANT WAS PERFORMED ON (B)(6) 2019. NO ADDITIONAL INTERVENTION WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 8364662 ↗
• InjuryDec 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00, 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED BUT PATIENT DEVELOPED DYSPHOTOPSIA ALMOST IMMEDIATELY AFTER IMPLANT. THE LENS WAS EXPLANTED. NO INCISION ENLARGEMENT, NO VITRECTOMY, NO COMPLICATIONS, NO ADDITIONAL INTERVENTION REQUIRED, AND THERE WAS NO CONTRIBUTING MEDICAL HISTORY REPORTED. PATIENT DOING WELL AFTER DISCHARGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8207270 ↗
• InjuryNov 6, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT TECNIS MULTIFOCAL (MODEL ZLB00 +20.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE BECAUSE OF MECHANICAL COMPLICATION OF INTRAOCULAR LENS. THERE WAS NO PATIENT INJURY. REPORTEDLY AN AAB00, +19.0 DIOPTER LENS WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS STABLE AND HAD NO COMPLAINTS OR CONCERNS AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8040811 ↗
• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 20.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT WAS DISSATISFIED WITH THE DECREASE IN CONTRAST WITH THE LENS IMPLANTED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 8001373 ↗
• InjuryApr 10, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT DOCTOR OBSERVED A SCRATCH ON THE CENTER OPTIC OF A TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZLB00, +20.0 DIOPTER) FOLLOWING A YAG PROCEDURE. THE PATIENT REPORTED HE EXPERIENCED HAZY VISION AND GLARE DURING A POSTOP EXAMINATION. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE DOCTOR IS CONSIDERING A FUTURE EXPLANT; HOWEVER, IS REFERRING THE PATIENT TO ANOTHER SURGEON DUE TO THE POSTERIOR YAG. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Vitrectomy

  MAUDE report 7419912 ↗
• InjuryMar 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2016. POST-OPERATIVELY, THE PATIENT EXPERIENCED SHADOWS AND BLURRED VISION THAT BECOMES WORSE IN BRIGHTER LIGHT, BUT IS ALSO EVIDENT IN LOW LIGHT. REPORTEDLY, THE DOCTOR RECOMMENDED THE PATIENT TO HAVE A YTTRIUM-ALUMINUM GARNET (YAG) PROCEDURE, WHICH SHE DID HAVE COMPLETED ON (B)(6) 2017, BUT IT DID NOT HELP. FURTHERMORE, THE PATIENT IS USING EYE DROPS BECAUSE THE DOCTOR THINKS THE PATIENT MAY HAVE DRY EYES. HOWEVER, THE PATIENT STATED THEY ARE NOT HELPING THE PROBLEM. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Dry Eye(s); Visual Disturbances

  MAUDE report 7338352 ↗
• InjuryMar 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. POST-OPERATIVELY, SINCE THE DAY AFTER SURGERY, THE PATIENT HAS BEEN EXPERIENCING WORSE NEAR AND DISTANCE VISION AND A ''GHOSTING LINE,'' WHICH HAS NOT GONE AWAY. REPORTEDLY, THE PATIENT HAS BEEN BACK TO HER SURGEON A NUMBER OF TIMES LOOKING FOR SOME GUIDANCE. THE PATIENT IS CURRENTLY USING GLASSES, WHICH HAS IMPROVED HER VISION, BUT IT IS STILL NOT AS GOOD AS THE PATIENT WOULD LIKE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 7322414 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT CALLED TO REPORTED THAT A ZLB00 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO HIS RIGHT EYE (OD) AROUND (B)(6) 2017. POST-OPERATIVELY, THE PATIENT IS EXPERIENCING BLURRY VISION, HALOS, GLARE, STARBURSTS, SEEING DOUBLE AT NIGHT, FEELING LIKE FOREIGN MATTER IS IN THE EYE, COLORS ARE NOT AS GOOD AS THEY USED TO BE; LOOKED WASHED OUT, AND BEING UNABLE TO MAKE OUT DETAILS. THE PATIENT STATED THAT HE IS VERY FRUSTRATED, DEPRESSED, AND ANGRY. THE PATIENT HAS BEEN BACK TO THE DOCTOR, WHO KEEPS TELLING THE PATIENT TO GIVE IT MORE TIME FOR HIS BRAIN TO ADAPT, BUT DOESN'T FEEL HE IS GETTING THE ISSUES RESOLVED. THE PATIENT HAD A YTTRIUM-ALUMINUM GARNET (YAG) PERFORMED ABOUT A WEEK AGO DUE TO SCAR TISSUE GROWING OVER THE LENS. THERE WERE NO INJURIES REPORTED AND THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Dry Eye(s); Halo; Visual Disturbances; Visual Impairment

  MAUDE report 7111150 ↗
• InjuryOct 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT COMPLAINED OF A CRESCENT ACROSS HIS VISION. THEREFORE, THE DOCTOR DECIDED TO REPOSITION THE LENS. DURING THE REPOSITIONING, THE DOCTOR NOTICED THE HAPTIC WAS NOT IN THE CAPSULAR BAG AND PLACED IT BACK IN. AFTER THE REPOSITIONING PROCEDURE, THE CRESCENT WAS STILL PRESENT, BUT ROTATED IN A DIFFERENT POSITION THAN BEFORE. THE DOCTOR ENDED UP EXPLANTING THE LENS ON (B)(6) 2017 AND REPLACED THE LENS WITH A ZMA00 19.0 DIOPTER IOL. THERE WAS AN INCISION ENLARGEMENT AND ONE SUTURE USED, BUT A VITRECTOMY WAS NOT PERFORMED. THE PATIENT IS DOING FINE WITH NO POST-OPERATIVE INJURY, BUT STILL COMPLAINS OF SEEING THE CRESCENT SHAPE (AT 11 O'' CLOCK TO 5 O'' CLOCK). REPORTEDLY, THE DOCTOR CONFIRMED THAT THE CRESCENT SHAPE WAS NOT DUE TO THE LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6932760 ↗
• InjuryAug 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BLURRY VISION WAS REPORTED FROM A FEMALE PATIENT WHO HAD A MULTIFOCAL LENS (MODEL ZLB00 +20.0 DIOPTERS) IMPLANTED IN HER LEFT EYE. THE PATIENT WAS EXAMINED BY THE DOCTOR WHO ADVISED THAT THERE WAS POSSIBLY SOMETHING WRONG WITH THE EYE (NO DETAILS ON THIS DIAGNOSIS). THE PATIENT ALSO VISITED A RETINA SPECIALIST, WHO CONFIRMED THAT THE LENS WAS WELL POSITIONED. REPORTEDLY, GLARE WAS PRESENT BUT THE PATIENT WAS NOT TOO CONCERNED. THE PATIENT'S CURRENT VISUAL ACUITY UNCORRECTED WAS 20/50. DURING THE SURGERY, THERE WERE NO ISSUES WITH REMOVING THE CATARACT. THE PATIENT WAS CONCERNED SINCE PRE-OP HER VISUAL ACUITY WAS 20/50 AND THE IMPLANTED LENS DID NOT IMPROVED HER DISTANCE VISION. HER NEAR VISION WAS ALSO BLURRY. THE SURGEON WAS CONSIDERING TRYING THE PATIENT WITH A CONTACT LENS. THE PATIENT VISITED THE SURGEON ON (B)(6) 2017 AND THEY DECIDED TO EXCHANGE THE LENS AS THERE HAD BEEN NO SIGNIFICANT CHANGES IN THE PATIENT'S DISTANCE OR READING VISION SINCE THE MULTIFOCAL ZLB00 WAS IMPLANTED SIX WEEKS EARLIER. THE PATIENT ALSO REPORTED THAT SHE NOTICES THAT EARLY IN THE DAY HER DISTANCE VISION IN THE LEFT EYE SEEMED CLEARER. AS THE DAY WORN ON, SO DID THE CLEARNESS. REPORTEDLY, THE PATIENT

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6772836 ↗
• InjuryAug 4, 2017Adverse 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 FROM A FEMALE PATIENT'S RIGHT EYE (OD) DUE TO INTRACTABLE GLARE AND POOR QUALITY OF VISION. IT WAS STATED THAT BOTH EYES (OU) WERE EFFECTED, HOWEVER; AS OF NOW THEY HAVE ONLY EXPLANTED THE RIGHT EYE. THE DOCTOR IS HOPING WITH EXCHANGING OF THE PATIENT'S DOMINANT EYE'S IOL, PERHAPS THEY CAN AVOID THE LEFT EYE IMPLANT REMOVAL. THERE WAS NO SUTURES OR VITRECTOMY REQUIRED. THERE WAS SLIGHT WOUND ENLARGEMENT TO ACCOMMODATE IOL WHICH WAS FOLDED INTRA-CAMERALLY. THERE WAS NO POST-OP INCIDENT REPORTED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6769515 ↗
• InjuryApr 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN EXPLANT OF AN INTRAOCULAR LENS, MODEL ZLB00, WAS PERFORMED ON THE RIGHT EYE (OD) OF A FEMALE PATIENT DUE TO THE PATIENT COMPLAINT OF VERTIGO AND BLURRY VISION. THE LENS WAS REPLACED WITH A MODEL ZCB00 LENS, 20.0 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED AND THERE WAS NO POST-OP INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Vertigo

  MAUDE report 6474730 ↗
• InjuryNov 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A ZLB00 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A PATIENT DISSATISFACTION WITH WAXY VISION AND GLARE IN THE LEFT EYE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. THERE WAS NO PATIENT POST-OP INJURY.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 6119605 ↗
• InjuryNov 18, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BILATERAL LENS EXCHANGE WAS REQUIRED. A ZLB00 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A PATIENT EXPERIENCING WAXY VISION AND GLARE IN THE LEFT EYE. LENS WAS REPLACED WITH A ZXR00 IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. THERE WAS NO PATIENT POST-OP INJURY. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE LEFT EYE AND SEPARATE MDR WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 6115333 ↗