TECNIS IOL ZLB00 (REF ZLB00U0195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 05050474560666), received between Sep 1, 2016 and Jan 19, 2024 — classified as 21 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 25 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2024Break; Break

  IT WAS REPORTED THE ZLB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). PATIENT REPORTS COMPLAINTS OF NOT MUCH IMPROVEMENT AND VISION MAY BE WORSE THAN WHAT HE CAME IN WITH. THERE IS NOT THE CLARITY AS THERE IS IN THE OCULAR SINISTER (LEFT EYE) AND HE EQUATES IT TO LOOKING THROUGH A FILTERED LENS. HE ALSO REPORTS THERE IS A SECTION THAT IS BLURRY OR OUT OF FOCUS THAT SEEMS TO BE THE BOTTOM HALF OF MY SIGHT WHEN TRYING TO READ SOMETHING; LIKE JUST OPENING YOUR EYES IN THE MORNING EXCEPT IT'S 24/7. A YTTRIUM ALUMINUM GARNET (YAG) PROCEDURE WAS PERFORMED. ACCORDING TO A RETINA SPECIALIST, THERE IS NOTHING ABOUT THE PATIENT'S EYE'S "HEALTH" THAT WOULD CONTRIBUTE TO THE PATIENT VISUAL ISSUES. HOWEVER, A SMALL CREASE WAS NOTED BUT THE RETINA SPECIALIST DID NOT THINK IT CONTRIBUTED TO THE REPORTED COMPLAINTS. THE RETINA SPECIALIST REFERRED THE PATIENT BACK TO THE CATARACT SURGEON. PATIENT STATED IF BOTH EYES WERE LIKE THIS AT NIGHT HE WOULD NOT BE ABLE TO DRIVE. PATIENT IS ANNOYED TO HAVE FILTERED BLURRY VISION FROM ONE EYE AND BE TOLD HIS EYE IS HEALTHY. SALES REP REPORTED COMPLAINTS CLOUDY VISION, BLURRY VISION, LIKE SOMETHING IS IN FRONT OF IT

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 18548472 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INDICATED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S RIGHT EYE DUE TO HAZY VISION. A NON-JOHNSON AND JOHNSON LENS OF THE SAME DIOPTER WAS USED AS THE REPLACEMENT. THERE WERE NO OTHER SURGICAL INTERVENTIONS REQUIRED AND NO INJURY SUCH AS CAPSULE TEAR REPORTED. THE PATIENT OUTCOME WAS GOOD. SUSPECT IOL WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 16319923 ↗
• InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED THAT SHE CANNOT SEE AT NIGHT OR DRIVE AT NIGHT; HAS DOUBLE VISION, AND MUST SQUINT HER EYES TO SEE. SHE INDICATED SHE SPOKE WITH HER DOCTOR AND THE DOCTOR TOLD HER, HE DID NOT KNOW WHY SHE WAS NOT ABLE TO SEE. SHE ALSO INDICATED SHE WENT TO A RETINA SPECIALIST AND WAS TOLD SHE HAD NOTHING WRONG WITH HER RETINAS. SHE MENTIONED SHE HAD YAG SURGERY 1 MONTH AGO FOR POSSIBLE SECONDARY CATARACT AND IT DID NOT HELP HER VISION. SHE WAS PRESCRIBED SEVERAL EYE DROPS AND IT IS NOT HELPING HER VISION. SHE ALSO SAID SHE IS EXPERIENCING DRY EYE AND STARTED AFTER THE CATARACT SURGERY. SHE IS VERY UPSET THAT SHE HAS SEVERE GLARE. HER VISION IS WORST THAN BEFORE CATARACT SURGERY. SHE CANNOT SEE EVEN WITH GLASSES.

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

  MAUDE report 12178567 ↗
• MalfunctionApr 7, 2021Inaccurate Delivery; Difficult to Advance; Inaccurate Delivery; Difficult to Advance

  IT WAS REPORTED THAT A MODEL ZLB00 INTRAOCULAR LENS(IOL) WAS PARTIALLY INSERTED INTO THE PATIENT'S LEFT EYE, BUT DUE TO PREMATURE LENS ADVANCEMENT THE LENS HAD TO BE REMOVED AND WAS REPLACED WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY, INCISION ENLARGEMENT, UNPLANNED SUTURE OR VITRECTOMY. ADDITIONAL DETAILS RECEIVED CONFIRMS THAT UNCONTROLLED DELIVERY OF LENS INTO THE EYE TOOK PLACE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11625995 ↗
• InjuryAug 20, 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 DUE TO PATIENT BEING HYPEROPIC. THE REPLACEMENT IS A DIFFERENT MODEL, ZXT150, AND HIGHER DIOPTER 20.5. THERE WAS NO ADVERSE REPORT, NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10429516 ↗
• InjuryMar 5, 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) 19.5 DIOPTER WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE. PRE VISUAL ACUITY WAS 20/70+, POST VISUAL ACUITY IS 20/30. THE PATIENT WAS NOT HAPPY, AND WAS EXPERIENCING FUZZY, MILKY VISION. THE PATIENT ALSO EXPERIENCED BLURRY VISION BOTH DISTANCE AND NEAR. THE IOL WAS EXPLANTED AND REPLACED WITH A NON J&J LENS. THERE WAS NO CAPSULE TEAR, VITRECTOMY OR SUTURES REQUIRED, BUT THE INCISION WAS ENLARGED. THE PATIENT IS DOING WELL POST EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 9791244 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A MODEL ZLB00 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2019. THE ZLB00 LENS WAS LATER EXPLANTED DUE TO THE WRONG POWER LENS WAS IMPLANTED. THE REPLACEMENT WAS ANOTHER ZLB00, BUT WITH HIGHER DIOPTER, 22.0. PRIOR REFRACTION WAS NOTED TO BE 19.5. THERE WAS NO INCISION ENLARGEMENT, AND NO VITRECTOMY HOWEVER, SUTURE(S) WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9406600 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A MODEL ZLB00 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE ON (B)(6) 2019. THE ZLB00 LENS WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH HIS VISION SINCE LENS PLACEMENT, AND READING DISTANCE WAS AN ISSUE. THE ZLB00 LENS WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9339697 ↗
• InjuryOct 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT INTOLERANT WITH AN INTRAOCULAR LENS (IOL). THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON & JOHNSON LENS. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. REPORTEDLY, THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9244207 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZLB00 19.5 DIOPTER LENS WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE. THERE WAS NO VITRECTOMY OR INCISION ENLARGEMENT REQUIRED. THE PATIENT WAS UNABLE TO FOCUS AND WAS DISSATISFIED WITH THEIR NEAR VISION. THE PATIENT IS A DENTAL HYGIENIST. AFTER SEVERAL MONTHS, THE PATIENT DESCRIBED THEIR VISION AS FOG AND SLIGHT DOUBLE VISION. ADDITIONALLY, THEY EXPERIENCED DRY EYES WHICH THEIR DOCTOR TREATED WITHOUT SUCCESS. THE EXPLANTED LENS WAS REPLACED WITH MODEL PCBOO 19.0 DIOPTER. REPORTEDLY, THE PATIENT OUTCOME IS SATISFACTORY. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 9194537 ↗
• InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A MODEL ZLB00 19.5 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. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8963627 ↗
• InjuryMar 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT LENS MODEL, ZLB00 MULTIFOCAL IOL (INTRAOCULAR LENS) HAD DISLOCATED IN THE PATIENT'S RIGHT EYE (OD) AFTER IMPLANTATION. THE DOCTOR FURTHER COMMENTED THAT CYLINDER IS OFF (ASTIGMATISM) ALONG WITH A REFRACTIVE ERROR. THE LENS WAS EXPLANTED AND REPLACED WITH +19.5 DIOPTER LENS MODEL, ZXT150. NO INCISION ENLARGEMENT AND PATIENT RECOVERED AFTER THE REPLACEMENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8446075 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS MODEL, ZLB00 MULTIFOCAL IOL (INTRAOCULAR LENS) WAS EXPLANTED FROM PATIENT'S LEFT EYE (OS) DUE TO DISSATISFACTION. IT WAS ALSO NOTED THAT THERE WAS A INCISION ENLARGEMENT, BUT THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8428988 ↗
• InjuryMar 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS MODEL, ZLB00 MULTIFOCAL IOL (INTRAOCULAR LENS) WAS EXPLANTED FROM PATIENT'S EYE. THE REASON OF EXPLANT IS UNKNOWN, NOT PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8410826 ↗
• MalfunctionMay 2, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER THE LENS WAS INSERTED INTO THE PATIENT'S RIGHT EYE, TWO LARGE SCRATCHES WERE OBSERVED ACROSS THE OPTIC. THE LENS WAS THEN REMOVED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY AND NO SURGICAL OR MEDICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7482157 ↗
• InjuryApr 28, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZLB00, +19.5 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING VISUAL DISTURBANCE AND UNEXPECTED POST OP REFRACTION. IT WAS ALSO REPORTED THAT PATIENT WAS UNABLE TO FOCUS, AND VISION INTERFERED WITH DAILY ACTIVITIES. REPORTEDLY, TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZLB00, +20.5 DIOPTER) WAS USED AS REPLACEMENT LENS FOR THE PATIENT. THERE WAS NO INCISION ENLARGEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7471362 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE PATIENT REPORTED HIS VISION WAS GREAT FOLLOWING THE IMPLANTATION PROCEDURE EVEN THOUGH HE DEVELOPED A MINOR INFECTION WHICH WAS TREATED BY MEDICATION. HOWEVER, THE PATIENT EXPERIENCED VISUAL DIFFICULTIES AFTER A YTTRIUM-ALUMINUM GARNET (YAG) WAS PERFORMED IN (B)(6) 2017. THE PATIENT COMPLAINED OF NOT BEING ABLE TO READ UP CLOSE, DISTANCE VISION WAS BLURRY, SEEING HALOS AT NIGHT, DIZZINESS, AND HEADACHES. REPORTEDLY, THE DOCTOR EXPLAINED TO THE PATIENT THESE COMPLAINTS WERE DUE TO DRY EYES, WHICH THE PATIENT HAD TREATED FOR WITH PLUGS PRIOR TO CATARACT SURGERY. THE PATIENT STILL HAS DRY EYES. ALSO, WHEN THE PATIENT ASKED WHY THE YAG PROCEDURE WAS PERFORMED, THE DOCTOR'S REASON WAS BECAUSE IT WAS ROUTINE FOR THEIR OFFICE TO PERFORM THIS PROCEDURE AT A PATIENT'S ONE MONTH POST-OPERATIVE VISIT. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: Blurred Vision; Unspecified Infection; Visual Impairment

  MAUDE report 7162997 ↗
• InjuryJan 5, 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 MALE PATIENT'S LEFT EYE. THE ORIGINAL IMPLANT SURGERY WAS UNCOMPLICATED. HOWEVER THE PATIENT EXPERIENCED MARKED HALOS AND GHOSTS / VISUAL DISTURBANCE POST IMPLANT. THE SURGERY OUTCOME WAS INDICATED AS SIGNIFICANTLY INTERFERES WITH ACTIVITIES OF DAILY LIFE. THERE WAS NO INCISION ENLARGEMENT REQUIRED AT EXPLANT. THE PATIENT IS NOTED AS RECOVERED POST IOL EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 6224422 ↗
• InjuryNov 26, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, ZLB00, SERIAL NUMBER (B)(4) WAS IMPLANTED IN PATIENT'S RIGHT EYE ON (B)(6) 2016 AND ZKB00, SERIAL NUMBER (B)(4) WAS IMPLANTED IN PATIENT'S LEFT EYE ON (B)(6) 2016. IT WAS REPORTED THAT A PATIENT HAD +2.75 DIOPTER (D) IMPLANTED IN HIS EYES. THE PATIENT EXPERIENCED SEVERE HALOS AT NIGHT WHILE DRIVING. REPORTEDLY, PATIENT CONSIDERS REMOVAL OF THE LENSES IF THERE IS NO SOLUTION. AS PER THE PATIENT, DOCTOR HAS RECOMMENDED TO GIVE IT TIME TO ADJUST. THE PATIENT IS HAPPY WITH HIS READING AND HE CAN DRIVE BUT HE IS CAUTIOUS WITH DISTANCE BECAUSE OF THE HALOS. PATIENT EXPECTED THAT DOING THE LEFT EYE MIGHT HELP IMPROVE HIS VISION BUT HE STILL HAS THE SEVERE HALOS. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS BEING FILED FOR THE RIGHT EYE IMPLANT ONLY AS THE DOCTOR HAS RECOMMENDED TO GIVE MORE TIME FOR IMPLANTS TO ADJUST.

  Patient problems: Halo

  MAUDE report 6128085 ↗
• InjuryNov 14, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE (OD) OF A FEMALE PATIENT DUE TO A WRONG POWER LENS WAS IMPLANTED. THE PATIENT'S SYMPTOMS WERE HALOS AND GLARE, VISUAL DISTURBANCE, AND POOR VISUAL QUALITY. THE PATIENT WAS PRE-OP SEQ -0.25 AND POST-OP SEQ +0.75. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 6100749 ↗
• InjuryNov 11, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT BILATERAL LENS IMPLANTS AND IS CURRENTLY EXPERIENCING UNEXPECTED POST OP REFRACTION AND VISUAL DISTURBANCE WITH GLAUCOMA. THE SYMPTOMS HAVE BEEN NOTED TO BE INTERFERING WITH THE ACTIVITIES OF DAILY LIFE FOR THE PATIENT. IT WAS REPORTED THAT THE DOCTOR IS THINKING OF REPLACING BOTH OF THESE MULTIFOCAL LENSES WITH MONOFOCAL LENSES. THE DOCTOR REFERRED THE PATIENT TO A SPECIALIST FOR CONSULTATION AND ASSISTANCE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT REPRESENTS THE LENS IMPLANT IN THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6095074 ↗
• MalfunctionOct 20, 2016Crack; Crack

  IT WAS REPORTED THAT DURING IMPLANTATION, AN INTRAOCULAR LENS (IOL) WAS OBSERVED CRACKED. PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6046206 ↗
• InjurySep 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO UNEXPECTED POST-OP REFRACTION. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES WERE REQUIRED. THE REPLACEMENT LENS WAS ANOTHER ZLB00 OF A HIGHER (20.5). THERE WAS NO POST-OP PATIENT INJURY.

  Patient problems: No Code Available

  MAUDE report 5978980 ↗
• MalfunctionSep 6, 2016Difficult or Delayed Positioning; Scratched Material; Difficult or Delayed Positioning; Scratched Material

  IT WAS REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THERE WERE SOME DIFFICULTIES INJECTING THE LENS (INTO THE EYE) AND THE LENS WAS SCRATCHED. NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNED THAT THE LENS WAS CUT AND REMOVED (FROM THE EYE) AND A NEW LENS WAS IMPLANTED. NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5931316 ↗
• InjurySep 1, 2016Adverse 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 A MALE PATIENT DUE A HYPEROPIC RESULT AND PATIENT BEING UNHAPPY WITH QUALITY OF VISION AT DISTANCE. THE LENS WAS REPLACED WITH A MODEL PCB00 LENS 20.5 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. THE PATIENT IS REPORTED AS OKAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 5920033 ↗