TECNIS IOL ZXR00 (REF ZXR00U0160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 05050474579019), received between Feb 7, 2017 and Jun 6, 2023 — classified as 23 injuries, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED BILATERAL INTRAOCULAR LENSES (IOLS). BOTH IOLS WERE EXPLANTED DUE TO GLARE, HALOS, DIFFICULTY NIGHT DRIVING. PATIENT DID NOT FEEL SAFE, OR BEING ANYWHERE THERE WERE LIGHTS. IT WAS STATED THAT THE VISUAL SYMPTOMS SIGNIFICANTLY INTERFERED WITH DAILY ACTIVITY. FURTHER REPORT STATED UNABLE TO DRIVE AT NIGHT DUE TO STARBURST. PATIENT DENIES ANY PAIN, DISCOMFORT, NEW FLASHES, OR FLOATERS FOR BOTH EYES. BUT PATIENT FEELS VISION WORSENED OVER THE LAST FEW MONTHS. IT WAS NOTED THAT THE CONTACT PERSON STATED THAT PATIENT'S VISUAL ISSUES OCCURRED POST-IMPLANT RIGHT AWAY HOWEVER WAS DIAGNOSED ON (B)(6) 2022. NON-JOHNSON AND JOHNSON LENSES WERE USED AS REPLACEMENT (15.5 DIOPTER IN RIGHT EYE, 15.0 DIOPTER IN LEFT EYE). THERE WAS NO VITRECTOMY OR SUTURES DONE. PATIENT WAS GREAT POST-OP, NO HALO OR GLARE SEEING 20/20 UNCORRECTED IN THE DISTANCE AND J5 UNCORRECTED. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE RIGHT EYE (OD). A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE (OS).

  Patient problems: Blurred Vision; Flashers; Halo; Visual Disturbances

  MAUDE report 17067929 ↗
• InjuryOct 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE DUE TO BEING DISLOCATED (SUBLUXED LENS). THE REPLACEMENT LENS WAS OF THE SAME MODEL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Visual Disturbances

  MAUDE report 12686511 ↗
• InjuryJun 25, 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 A PATIENT'S OPERATIVE EYE DUE TO POWER MISS. A REPLACEMENT LENS OF THE SAME MODEL WAS USED. THE EXPLANTED LENS WAS DISCARDED AT THE CUSTOMER SITE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 12071900 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. IOL WAS EXPLANTED DUE TO +2 HYPEROPIC RESULTS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 11469145 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) COULD NOT ADAPT TO THE GLARE RIGHT AFTER IT WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. IT WAS STATED THAT THE PATIENT ALSO HAD LOSS OF 2 OR MORE LINES OF BSCVA (BEST SPECTACLE CORRECTED VISUAL ACUITY). THE SUSPECT IOL WAS REPLACED WITH A DIFFERENT MODEL, DIFFERENT DIOPTER POWER IOL WITH EXCELLENT POST-OP RESULTS. THERE WAS NO COMPLICATIONS, NO PATIENT POST-OP INJURIES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 10393683 ↗
• InjuryApr 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXR00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S OCULAR SINISTER (LEFT EYE) DUE TO COMPLAINTS OF DYSPHOTOPSIA. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9930654 ↗
• InjuryJun 10, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AS THE LENS MALFUNCTIONED. REPORTEDLY, THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. ANOTHER LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING WELL. THE CUSTOMER WAS UNABLE TO PROVIDE ANY MORE INFORMATION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8684476 ↗
• InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 16.0 INTRAOCULAR LENS WAS IMPLANTED INTO THE PATIENT LEFT EYE ON (B)(6) 2018. THE PATIENT COMPLAINED OF SEVERE GLARE AND SPIDER WEBS FROM BOTH EYES. AN IOL EXCHANGE WAS PERFORMED ON (B)(6) 2019. THE PATIENT IS DOING VERY WELL AFTER IS IOL EXCHANGE AND NOTES IMPROVEMENT IN HIS COMPLAINTS. THE COMPLAINT PRODUCT WAS DISCARDED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8333365 ↗
• InjuryDec 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 16.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT COMPLAINED THAT SHE WAS PROMISED TO BE ABLE TO READ WITHOUT GLASSES, HOWEVER, THE PATIENT IS HAVING TO USE 1.25 READING GLASSES. POST-OPERATIVELY AT A FOLLOW UP VISIT ON (B)(6) 2017, THE PATIENT'S VISUAL ACUITY IN THE RIGHT EYE WAS 20/20-2 WITH AN INTRAOCULAR PRESSURE OF 19. AT A FOLLOW UP VISIT ON (B)(6) 2018, THE PATIENT WAS DIAGNOSED WITH MILD EPITHELIAL BASEMENT MEMBRANE DYSTROPHY (EBMD) AND PRESCRIBED MURO 128, 5% EYE DROPS (1 DROP IN EACH EYE FOUR TIMES PER DAY). ALSO, THE PATIENT'S VISUAL ACUITY IN THE RIGHT EYE WAS 20/20, THE AUTO REFRACTION WAS 0.50 X 0.50 X 80, AND THE MANIFEST REFRACTION WAS 0.25 SPHERE WITH VISUAL ACUITY 20/20. THE PATIENT'S NEAR VISION TEST RESULTS WERE J3. AT A FOLLOW UP VISIT ON (B)(6) 2018, THE PATIENT'S VISUAL ACUITY IN THE RIGHT EYE WAS 20/25 AND THE MANIFEST REFRACTION WAS -0.50 SPHERE, ADD 1.50 WITH VISUAL ACUITY 20/20. ALSO, THE PATIENT WAS TOLD IT WAS OKAY TO USE OVER THE COUNTER GLASSES +1.00. AT A FOLLOW UP VISIT ON (B)(6) 2018, THE PATIENT'S VISUAL ACUITY IN THE RIGHT EYE WAS -0.50 SPHERE WITH VISUAL ACU

  Patient problems: No Code Available

  MAUDE report 8172219 ↗
• InjuryNov 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXR00 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) OF A FEMALE PATIENT ON (B)(6) 2018. REPORTEDLY, THE PATIENT COMPLAINED THAT THE VISION WAS POOR, ESPECIALLY AT NIGHT. THE UNCORRECTED DISTANCE VISUAL ACUITY IN THE RIGHT WAS NOT GOOD AND SHE DID NOT SEE WELL IN DIM LIGHT; THE INTERMEDIATE VISION WAS JUST OKAY. AN EXPLANT WAS SCHEDULED FOR THE RIGHT EYE ON (B)(6) 2018. VISUAL ACUITY (VA) PRE-OP: 20/50, J2 WITH CORRECTION; 20/400 GLARE TEST; 1 DAY POST-OP: UC (UNCORRECTED) DISTANCE: 20/40-2, UC INTERMEDIATE: J7; 6 DAY POST-OP: UC DISTANCE : 20/30, UC INTERMEDIATE: J10; 13 DAY POST-OP: UC DISTANCE: 20/40, UC INTERMEDIATE : JS; 25 DAY POST-OP: UC DISTANCE: 20/40, UC INTERMEDIATE: J4; 2 MONTH POST-OP: UC DISTANCE: 20/60+1, UC INTERMEDIATE: J2; 6 MONTH POST-OP: UC DISTANCE: 20/60, UC INTERMEDIATE : J3. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8036892 ↗
• InjuryOct 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS COMPLAINING OF SEVERE NIGHT TIME SPIDER WEB POST BILATERAL IMPLANTS OF MODEL ZXR00 TECNIS MULTIFOCAL IOL (INTRAOCULAR LENSES). THE PHYSICIAN HAS BEEN MANAGING THE OCULAR SURFACE. IT WAS NOTED THAT PATIENT'S SYMPTOM WAS FIRST NOTICED ON (B)(6) 2017 DURING HER FINAL VISIT FOR CATARACT SURGERY. ALSO NOTED IS THE PATIENT STATED THAT SHE CANNOT DRIVE AT NIGHT. AS A RESULT, YAG (YTTRIUM ALUMINUM GARNET) LASER WAS PERFORMED ON HER LEFT EYE (OS) ON (B)(6) 2018; AND SHE WAS PRESCRIBED WITH GLASSES AND WITH CRIZAL, BUT PATIENT STATED THAT IT DID NOT HELP HER WITH DRIVING. THERE WAS NO PATIENT INJURY HOWEVER. THE PRODUCT WILL NOT BE RETURNED AS IT REMAINS IMPLANTED. PRE-OP UNCORRECTED OS 20/70, PRE-OP CORRECTED OS 20/40, POST-OP UNCORRECTED OU (BOTH EYES) 20/20. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT PERTAINS TO LEFT EYE (OS).

  Patient problems: Visual Disturbances

  MAUDE report 7993286 ↗
• InjurySep 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO A NEGATIVE DYSPHOTOPSIA. THE REPLACEMENT LENS WAS A ZCB00 15.5 DIOPTER LENS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. REPORTEDLY, THE PATIENT IS DOING GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT HAS BILATERAL IMPLANTS. THIS REPORT REPRESENTS THE LEFT EYE.

  Patient problems: No Code Available

  MAUDE report 7857046 ↗
• InjuryJul 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXR00 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE ON (B)(6) 2018. IMMEDIATELY FOLLOWING THE SURGERY THE PATIENT COMPLAINED OF BLURRED VISION. REPORTEDLY, THE LENS WAS EXPLANTED ON (B)(6) 2018 AND REPLACED WITH A ZCB00 +16.0 DIOPTER LENS. THERE WERE NO INCISION ENLARGEMENT, NO PATIENT HARM AND NO VITRECTOMY. THE PATIENT WAS REPORTED BEING ALERT AND ORIENTED WHEN DISCHARGED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE PATIENT'S VISION IMPROVED AFTER THE EXPLANT AND THE PATIENT IS NOW HAPPY WITH THE VISION IN THE RIGHT EYE. THE EXPLANTED LENS WAS DISCARDED BY THE ACCOUNT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7717480 ↗
• InjuryJul 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH TWO TECNIS SYMFONY INTRAOCULAR LENSES (IOL) AND EXPERIENCED PROFOUND STARBURSTS AND HALOS ALMOST IMMEDIATELY AFTER SURGERY. THE PATIENT INDICATED THAT HE CONTINUES TO HAVE SEVERE PROBLEMS WITH NIGHT DRIVING AND THAT HE SEES CONCENTRIC CIRCLES AROUND TRAFFIC LIGHTS RADIATING OUTWARD ABOUT FOUR OR FIVE TIMES THE DIAMETER OF THE LIGHT. HE INDICATED THAT HE SEES LARGE HALOS AROUND STREET LIGHTS, TRAFFIC LIGHTS, THE MOON, IN THE THEATER AND ANY LIGHT IN THE DARK. THE PATIENT ALSO MENTIONED THAT HE SEES VERY DISTRACTING AND LARGE STARBURSTS FROM ONCOMING HEADLIGHTS, SO LARGE THAT THEY SOMETIMES BLOCK OUT MOST OF HIS LANE. THE PATIENT REPORTED THAT HE WAS INVOLVED IN A TRAFFIC ACCIDENT WHERE HE HIT ANOTHER CAR. THE SURGEON PERFORMED A YAG LASER CAPSULOTOMY ON THE LEFT EYE SHORTLY AFTER SURGERY, AS THE PATIENT HAD DEVELOPED A SECONDARY CATARACT/ PCO (POSTERIOR CAPSULE OPACIFICATION). HOWEVER, THE CUSTOMER MENTIONED THAT THE YAG LASER CAPSULOTOMY DID NOT CHANGE ANYTHING. THE PATIENT HAS TRIED YELLOW ANTI-GLARE NIGHT DRIVING GLASSES, BUT THEY HAVE NOT BEEN NOT HELPFUL. THE DOCTOR SUGGESTED A YAG ON THE RIGHT EYE ALTHOUGH HE DID NOT SEE ANY

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 7708698 ↗
• InjuryJun 11, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE ON (B)(6) 2018 AND EXPLANTED ON (B)(6) 2018 DUE TO A MECHANICAL FAILURE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO PATIENT INJURY, NO SUTURE(S), NO VITRECTOMY, THE INCISION WAS ENLARGED, AND THE DOCTOR USED THE SAME INCISION TO REMOVE THE LENS IN ONE PIECE. THROUGH FOLLOW UP, THE CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION STATING THE REPORTED MECHANICAL FAILURE SYMPTOMS WERE INITIALLY REPORTED BY THE PATIENT AND FIRST OBSERVED ON (B)(6) 2018, BLURRY VISION WITH ALL ACTIVITIES ESPECIALLY WHEN DRIVING. THE PATIENT WAS INSTRUCTED TO USE ARTIFICIAL TEARS ON A SET SCHEDULE TO SEE IF VISUAL SYMPTOMS WERE RELATED TO DRYNESS. FURTHER EVALUATION WAS PERFORMED ON 11-APR-2018, THE PATIENT REPORTED NO RESOLUTION OF VISUAL SYMPTOMS WITH THE ARTIFICIAL TEAR USE. THE MECHANICAL FAILURE SYMPTOMS OF CONTINUED BLURRY VISION AND GHOSTING OF IMAGES WITH SHADOWS AROUND IMAGES, ESPECIALLY WITH DRIVING, WERE NOT RESOLVED WITH SPECTACLE CORRECTION. THE EXPLANTED LENS WAS REPLACED WITH AN MODEL AAB00 16.5 DIOPTER LENS. PATIENT OUTCOME POST-LENS EXCHANGE WAS GOOD AS REPORTED BY THE PATIENT, AND REPORTED

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

  MAUDE report 7585587 ↗
• InjuryMar 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXR00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION, INC.

  Patient problems: No Code Available

  MAUDE report 7308772 ↗
• InjuryFeb 8, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXR00 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO A REFRACTIVE ERROR. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER OF 14.5. THERE WAS NO INCISION ENLARGEMENT OR SUTURES USED. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7258512 ↗
• InjuryJan 5, 2018Invalid Sensing; Invalid Sensing

  IT WAS REPORTED THAT A ZXR00 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE LEFT EYE (OS) OF THE PATIENT ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE PATIENT COMPLAINING OF EXTREME GLARE, AS WELL AS BLURRED VISION AT BOTH NEAR AND DISTANCE FOCAL LENGTHS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. THE LENS WAS REPLACED WITH A NON-AMO LENS WITH 15.5 DIOPTER. REPORTEDLY, THE PATIENT IS DOING WELL AND HAPPY WITH THE NEW LENS. PATIENT IS REPORTING GOOD DISTANCE VA (VISUAL ACUITY) AND NO COMPLAINTS OF GLARE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7170480 ↗
• InjuryNov 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. REPORTEDLY, THE PATIENT COMPLAINED OF SEVERE GLARE AND VISION LOSS. 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: No Code Available; Visual Impairment

  MAUDE report 7004791 ↗
• InjuryOct 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A ZXR00 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. THERE IS A PLANNED EXPLANT ON (B)(6) 2017 BECAUSE THE PATIENT WAS UNHAPPY WITH THE LENS. REPORTEDLY, THE LENS WILL BE REPLACED WITH A ZLB00 16.5 DIOPTER IOL. PRE-OPERATIVELY, ON (B)(6) 2017, THE PATIENT'S VISUAL ACUITY WAS 20/100, PIN HOLE (PH) VISUAL ACUITY WAS 20/40+, AND REFRACTION WAS -1.25 X +0.25 X 159. POST-OPERATIVELY, DAY ONE, (B)(6) 2016, THE PATIENT WAS J10 AND HAD A LITTLE BIT OF EDEMA. IN ADDITION, VISUAL ACUITY WAS 20/50- WITH NO IMPROVEMENT USING PIN HOLES. ON (B)(6) 2017, AT THE PATIENT ONE WEEK POST-OPERATIVE VISIT, THE PATIENT COMPLAINED OF UNABLE TO READ UP CLOSE, AT DISTANCE, PRINT IS ALMOST DOUBLE AND SHADOWY. FURTHERMORE, THE PATIENT'S UNCORRECTED VISUAL ACUITY (UCVA) WAS 20/30 AND BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/20, WITH A REFRACTION OF +0.25 X +0.75 X 040. LATER, ADDITIONAL INFORMATION WAS PROVIDED. IT WAS CONFIRMED THE LENS WAS EXPLANTED ON (B)(6) 2017 WITHOUT COMPLICATION, NO VITRECTOMY OR SUTURES WERE REQUIRED AND THERE WAS NO PATIENT INJURY POST-OP. THE REPLACEMENT LENS WAS A ZLB00 16.5 DIOPTER IOL. NO ADDITIONAL INFOR

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

  MAUDE report 6992336 ↗
• InjuryJul 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY, MODEL ZXR00 (16.0 DIOPTER) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE (OD) DUE TO MECHANICAL COMPLICATION DEFINED AS INTOLERANCE, WHERE THE PATIENT WAS UNABLE TO ADAPT TO THE LENS. THE LENS WAS REPLACED WITH ANOTHER LENS, MODEL ZCBOO (16.0 DIOPTER). ADDITIONALLY IT WAS INDICATED THAT THERE WAS NOTHING WRONG WITH THE LENS. THE PATIENT COULD NOT ADAPT TO THE LENS AND HAS AN EPIRETINAL MEMBRANE WITH A MACULAR PUCKER FOLLOWING CATARACT SURGERY THAT COULD NOT BE SEEN BEFORE CATARACT SURGERY. IT WAS CONFIRMED THAT NO INCISION ENLARGEMENT OR SUTURE WAS REQUIRED AND NO VITRECTOMY WAS PERFORMED. THERE WAS NO PATIENT POST-OP INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6723482 ↗
• MalfunctionMay 5, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT PRIOR TO LOADING OF AN INTRAOCULAR LENS (IOL) INTO THE CARTRIDGE, A SCRATCH WAS NOTICED ON THE LENS THROUGH A MICROSCOPE. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6549723 ↗
• InjuryFeb 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXR00 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT NOT BEING HAPPY WITH HIS VISION. THE PATIENT WAS EXPERIENCING BLURRED VISION. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. THERE WAS NO PATIENT POST-OP INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6359019 ↗
• InjuryFeb 7, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO UNEXPECTED POST-OP REFRACTION. THE EXPLANTED LENS WAS A 16.0 AND THE REPLACEMENT WAS A LARGER, 19.5 DIOPTER LENS OF A DIFFERENT MODEL. THE NEW LENS/POWER GAVE THE PATIENT A MUCH BETTER RESULT. THERE WAS NO POST OP PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6309654 ↗