TECNIS IOL ZLB00 (REF ZLB00U0205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 05050474560680), received between Aug 22, 2016 and May 11, 2023 — classified as 42 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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.

• InjuryMay 11, 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 THE PATIENT'S RIGHT EYE. THE REASON FOR THE EXPLANT WAS NOT SPECIFIED. ANOTHER JOHNSON AND JOHNSON LENS OF DIFFERENT MODEL AND DIOPTER (AAB00 19.0D) WAS USED AS A REPLACEMENT. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury; Halo; Visual Disturbances

  MAUDE report 16912594 ↗
• InjuryJan 17, 2023Adverse 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. A NON-JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT. CHIEF COMPLAINT WAS THAT THE PATIENT COULD NOT BE CORRECTED TO 20/20 NEAR OR DISTANCE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED AND NO PATIENT INJURY. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 16189195 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING SIGNIFICANT VISION PROBLEMS AND POOR VISION WITH INTRAOCULAR LENS (IOL). THE PATIENT REPORTED SHE HAD MULTIPLE SURGERIES AFTERWARDS TO TRY AND CORRECT THE PROBLEMS, BUT TO NO AVAIL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT'S NIGHT DISTANCE IS BAD, ON-COMING HEADLIGHTS ARE OUT OF FOCUS, AND PATIENT COMPLAINED OF DRY EYES WHICH SHE DID NOT HAVE PRIOR TO SURGERY. THE PATIENT HAS BEEN USING OVER-THE-COUNTER (OTC) EYE DROPS TO RELIEVE THE DRY EYES. THE PATIENT HAD A YTTRIUM ALUMINUM GARNET (YAG) PERFORMED IN BOTH EYES (OU) SOMETIME IN 2016 AFTER HER IMPLANTS, HOWEVER, IT DID NOT HELP WITH HER VISUAL ISSUES. LASIK WAS PERFORMED IN THE LEFT EYE ONLY WHICH ALSO DID NOT HELP WITH HER VISUAL ISSUES. THE PATIENT ALSO TRIED HARD CONTACT LENSES (CL) WHICH WERE NO HELP. THE LENSES REMAIN IMPLANTED AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

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

  MAUDE report 12801460 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL), MODEL ZLB00, THE PATIENT COMPLAINED ABOUT HALOS, AND PHOTOPSIA IN THE RIGHT EYE (OD). GLARE INTOLERABLE BY PATIENT. PATIENT'S DAILY ACTIVITIES WERE AFFECTED. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND A NEW IOL, MODEL ZA9003, WAS IMPLANTED. INCISION ENLARGEMENT WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Halo; Visual Disturbances

  MAUDE report 12207805 ↗
• InjuryJul 8, 2021Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED AN INTRAOCULAR LENS (IOL) HAD MECHANICAL FAILURE REQUIRING AN EXPLANT WITH AN INCISION ENLARGEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Halo; No Clinical Signs, Symptoms or Conditions; Visual Disturbances

  MAUDE report 12140156 ↗
• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD), WAS REPOSITION ROTATIONALLY. PATIENT STATED VISION WAS GETTING GRADUALLY WORSE FOR SOME TIME NOW. VISION WAS SLIGHTLY BLURRY ON DAY 1 POST-OP. POOR SUPPORT WAS ALSO NOTED. PATIENT RETURNED TO REFERRING PHYSICIAN OUT OF STATE FOR FOLLOW UP CARE. THERE WAS NO INJURY. A PPV (PARS PLANA VITRECTOMY) AND A LRI (LIMBAL RELAXING INCISION) WERE PERFORMED. CARTRIDGE MODEL WAS NOT PROVIDED. THE LENS IS STILL IMPLANTED. NO OTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 11299257 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BILATERAL ZLB00 PATIENT ENDED UP 20/60 AT INTERMEDIATE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT A MODEL ZLB00 LENS WAS EXPLANTED FROM PATIENT''S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE. THERE WAS NO ISSUE WITH THE LENS. NO MEDICAL/SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES WERE REQUIRED. THE REPLACEMENT LENS USED IS A DIFFERENT MODEL ZKB00 WITH SAME DIOPTER LENS. THE PATIENT WAS BACK TO BASELINE AT THE TIME OF DISCHARGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10738231 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS EXPERIENCING SIGNIFICANT ISSUES WITH GLARE/HALOS AT NIGHT AND BLURRED VISION. PATIENT IS VERY UNHAPPY WITH VISUAL OUTCOME IN BOTH EYES. PATIENT HAS REQUESTED EXPLANT, AND STATES HE WASN'T EXPECTING VISION TO BE THIS BAD. EXPLANT PROCEDURE IS YET TO BE SCHEDULED. ADDITIONAL DETAILS FROM FOLLOW-UP STATE THAT THE PATIENT IS UNABLE TO READ WELL, AND EXPERIENCED LOSS OF 2 OR MORE LINES BEST CORRECTED SPECTACLE VISUAL ACUITY (BSCVA), NOT FOR DISTANCE, HIS NEAR VISION IS POOR. NO FURTHER INFORMATION PROVIDED. THIS MDR CAPTURES THE ISSUES RELATED TO PATIENT'S LEFT EYE. A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE ISSUES OF PATIENT'S RIGHT EYE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 10518308 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS DISSATISFIED WITH AN INTRAOCULAR LENS (IOL) AND WAS SCHEDULED TO EXPLANT THE LENS. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT WAS COMPLAINING OF NOT BE ABLE TO READ ON THE COMPUTER. THE VISUAL SYMPTOMS WERE SIGNIFICANTLY INTERFERING WITH NORMAL DAILY ACTIVITIES. VISION ACUITY IN LEFT EYE 20/30, RIGHT EYE 20/40, AND NEAR VISION IN BOTH EYES (OU) 20/30. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL, HIGHER DIOPTER.) THERE WAS NO PATIENT INJURY AND THERE WERE NO UNPLANNED SUTURES OR VITRECTOMY REQUIRED. THE REPLACEMENT LENS WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS RIGHT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE LEFT EYE.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 10310715 ↗
• MalfunctionJul 7, 2020Contamination; Contamination

  THE SURGEON IMPLANTED AN INTRAOCULAR LENS (IOL) IN THE PATIENT¿S OPERATIVE EYE AND OBSERVED A STRING-LIKE SUBSTANCE ADHERING TO THE TO THE MIDDLE OF THE OPTIC, THE POSTERIOR ASPECT OF THE LENS. THE SURGEON INDICATED THEY HAD TO WORK HARD AT REMOVING THE SUBSTANCE OFF THE LENS WITH IRRIGATION/ASPIRATION (I/A) BY RUBBING OPTIC UNTIL IT DISLODGED. IT WAS STATED THAT THE SUBSTANCE LOOKS BLUISH IN COLOR AND THAT THEY HAVE SEEN THIS ISSUE PRIMARILY WITH THE ZCB00 LENSES. IT WAS STATED THAT THIS IS THE FIRST TIME THEY ARE MENTIONING THIS ISSUE; HOWEVER, THE EVENT HAS BEEN HAPPENING FOR FEW MONTHS. ADDITIONALLY, IT WAS REPORTED THAT THE ACCOUNT DOES NOT NORMALLY CHECK THE LENSES BEFORE IMPLANTATION AND THE ISSUE IS USUALLY OBSERVED ONE DAY POST OPERATION. IT WAS ALSO INDICATED THAT THE ACCOUNT USES A COMPETITOR¿S (NON JOHNSON & JOHNSON DEVICE) INSERTER WITH THEIR CARTRIDGE (INCISION 2.2-2.4). THE LENS REMAINS IMPLANTED IN THE PATIENT'S EYE. THERE WAS NO SECONDARY SURGERY OR MEDICAL INTERVENTION REQUIRED AND NO DELAY IN PROCEDURE WAS REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. THE ACCOUNT REPORTED OF THE MOST RECENT EVENTS ON TWO LENSES. THIS REPORT IS FOR THE SECOND LENS OF MODEL Z

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10237919 ↗
• InjuryJan 14, 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) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO DYSPHOTOPSIA. NO SURGICAL INTERVENTIONS SUCH AS: VITRECTOMY; INCISION ENLARGEMENT; OR SUTURES WERE REQUIRED. THE REPLACEMENT LENS IS A ZCB00 21.0 DIOPTER LENS. PATIENT OUTCOME IS FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9587895 ↗
• InjuryDec 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 20.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO UNKNOWN/UNSPECIFIED CAUSE. THE LENS WAS REPLACED WITH THE SAME MODEL LENS, A HIGHER DIOPTER OF 21.5. THERE WAS NO COMPLICATION OR INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9398856 ↗
• 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 RIGHT (OD) 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 LENS IMPLANTS. THIS REPORT REPRESENTS THE RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

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

  MAUDE report 8787351 ↗
• InjuryJul 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SHE IS UNABLE TO SEE ANYTHING AS UP CLOSE AND INTERMEDIATE AS HER VISION IS BLURRY IN HER LEFT EYE. THE PATIENT CANNOT READ OFF OF HER COMPUTER, DO WORK, OR WRITE WITHOUT WEARING GLASSES. ADDITIONALLY, THE PATIENT COMPLAINED OF A BURNING FEELING RIGHT AFTER THE IMPLANT WAS DONE, BUT THE PAIN WENT AWAY. 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 LEFT EYE.

  Patient problems: Blurred Vision; Pain; Visual Disturbances

  MAUDE report 8770028 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 20.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018 AND WAS LATER EXPLANTED ON (B)(6) 2018. PATIENT WAS EXPERIENCING IMPAIRED VISION WITH BOTH DISTANCE AND NEAR VISION, AND SEVERE HALOS AT NIGHT. PATIENT ALSO INDICATED THAT THE SYMPTOMS WERE INTOLERABLE. A MODEL ZA9003 20.0 DIOPTER WAS THE REPLACEMENT LENS. INCISION WAS ENLARGED, NO SUTURE WAS USED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Impairment

  MAUDE report 8563259 ↗
• InjuryMar 12, 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 IN A SECONDARY PROCEDURE DUE TO ANSIOMETROPIA. PATIENT OUTCOME NOTED THAT THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8415258 ↗
• MalfunctionMar 11, 2019Break; Break

  IT WAS REPORTED THAT WHEN INSERTING A ZLB00 20.5D INTRAOCULAR LENS (IOL) INTO THE EYE, THERE WAS RESISTANCE AT THE TIME OF INJECTION. ADDITIONAL INFORMATION STATED THE IOL MAY HAVE BEEN DAMAGED DURING HANDLING BUT COULD NOT BE CONFIRMED. NO ADDITIONAL INFORMATION AS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8406797 ↗
• InjuryMar 5, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ZLB00 MULTIFOCAL IOL (INTRAOCULAR LENS) WAS NOTICED DISLOCATED IN THE PATIENT'S EYE AFTER IMPLANTATION. AS A RESULT, THE LENS WAS EXPLANTED. NO INCISION ENLARGEMENT, SUTURES OR VITRECTOMY WAS REQUIRED. THE ACCOUNT COMMENTED THAT THE EXPLANTED LENS IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8390690 ↗
• InjuryJan 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BILATERAL ZLB00 INTRAOCULAR LENS IMPLANTS. THE PATIENT REPORTED THAT SHE WAS TOLD THAT SHE WOULD NOT NEED GLASSES AFTER THE PROCEDURE HOWEVER SHE STILL NEEDS GLASSES FOR BOTH FAR AND CLOSE VISION. THE PATIENT ALSO REPORTS THAT SHE SEES MANY RINGS AROUND LIGHTS AT NIGHT, AND IT IS EXTREMELY DIFFICULT DRIVING AT NIGHT. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE LEFT EYE (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE (OD).

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8287945 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 20.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON AN UNKNOWN DATE OF SERVICE. IT WAS LATER EXPLANTED ON AN UNKNOWN DATE BECAUSE THE PATIENT'S CAPSULAR BAG ENDED UP NOT HAVING ENOUGH SUPPORT. THE REPLACEMENT LENS WAS A ZMA00 20.0 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8192822 ↗
• InjuryDec 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL ZLB00 (20.5 DIOPTER) WAS EXPLANTED DUE TO PATIENT'S DISSATISFACTION. PATIENT EXPERIENCED BLURRY, OUT OF FOCUS VISION IN BOTH EYES (OU) SINCE IMPLANT. REPORTEDLY, THE PATIENT VEHEMENTLY COMPLAINED THAT HER VISION WAS WORSE THAN BEFORE THE CATARACT SURGERY AND THAT SHE COULD NOT READ WITHOUT GLASSES; INTERMEDIATE VISION, SITTING ACROSS FROM SOMEONE, IS A BIG BLUR; AND THAT HER VISION GOES IN AND OUT OF FOCUS. THE PATIENT WAS VERY FRUSTRATED, HAD TROUBLE PERFORMING EVERY DAY TASKS, AND REPORTED THIS AFFECTED HER LIFE. AT EXPLANT, THE INCISION WAS ENLARGED AND SUTURES WERE REQUIRED. VISUAL ACUITY PRE-OPERATIVE: RIGHT EYE (OD): 20/30; VISUAL ACUITY POST-OPERATIVE: RIGHT EYE (OD): 20/30-20/40; OD-GLARE 20/80. NO FURTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO PATIENT'S RIGHT EYE (OD). A SEPARATE REPORT IS BEING FILED FOR THE PATIENT'S LEFT EYE (OS).

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

  MAUDE report 8122885 ↗
• InjuryNov 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 20.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON AN UNKNOWN DATE OF SERVICE. THERE ARE PLANS TO EXPLANT THE LENS BECAUSE RESIDUAL ASTIGMATISM EXISTS IN SPITE OF LASER AND MANUAL LIMBAL RELAXING INCISIONS (LRIS), ALSO NOTED IS PATIENT NEEDS A TORIC SYMFONY IOL. THE PATIENT ALSO COMPLAINS OF BLURRY VISION. THE PATIENT''S VISUAL ACUITY PRE-OPERATIVELY WAS 20/30-1 BEST CORRECTED VISUAL ACUITY (BCVA) AND THE PATIENT''S VISUAL ACUITY POST-OPERATIVELY WAS 20/40. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8054114 ↗
• InjuryJun 13, 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, +20.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING DYSPHOTOPSIA, VISUAL DISTURBANCE HALOS AND GLARES. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 7595079 ↗
• InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZLB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE. REPORTEDLY, THE WRONG TYPE, MODEL AND POWER LENS WAS SELECTED FOR THE PATIENT. THE LENS WAS REPLACED WITH A SYMFONY LENS, MODEL UNKNOWN. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7537101 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST IMPLANTATION OF A MODEL ZLB00 INTRAOCULAR LENS (IOL) THE PATIENT DISLIKED THE LENS AND IT WAS SUBSEQUENTLY EXPLANTED. THE EXPLANTED LENS WAS REPLACED WITH A MODEL ZCB00 LENS. NO ADDITIONAL INFORMATION PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7535618 ↗