TECNIS IOL ZXR00 (REF ZXR00U0170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 05050474579033), received between Jan 10, 2017 and May 4, 2022 — classified as 24 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 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 A PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO GLARE, STARBURSTS, AND HALOS. THE EXPLANTED LENS WAS REPLACED WITH ANOTHER JOHNSON AND JOHNSON LENS, MODEL ZA9003 OF 17.0 DIOPTER DURING THE SAME PROCEDURE. ALTHOUGH, IT WAS NOTED THAT THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH PATIENT'S ACTIVITIES OF DAILY LIFE; HOWEVER, THE PATIENT OUTCOME, STATUS WAS INDICATED AS UNKNOWN. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Halo; Visual Disturbances

  MAUDE report 14274840 ↗
• InjuryDec 17, 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 A PATIENT'S LEFT EYE DUE TO POST-OPERATIVE REFRACTIVE SURPRISE. THE PATIENT WAS POST-LASIK. THE REPLACEMENT LENS IS THE SAME MODEL, DIOPTER POWER WAS NOT PROVIDED. IT WAS INDICATED THAT THE SYMPTOM ONSET WAS DAY ONE. THE PATIENT HAS RECOVERED, AND POST-EXCHANGE, UNCORRECTED VISUAL ACUITY (UCVA) WAS REPORTED TO BE 20/20, AND THE PATIENT IS HAPPY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 11025501 ↗
• InjuryAug 12, 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 FROM THE PATIENT'S RIGHT EYE DUE TO INTOLERABLE GLARE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 10398984 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD UNDERGONE CATARACT SURGERY WITH A SYMFONY MULTIFOCAL LENS IMPLANTS IN BOTH EYES WHICH RESULTED IN BILATERAL POSITIVE DYSPHOTOPSIA, GLARE, AND STARBURSTS. INITIALLY, PLANNED EXPLANTS WERE SCHEDULED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT LENSES WERE EXPLANTED IN A SECONDARY SURGICAL PROCEDURE. NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES WERE REQUIRED. A DIFFERENT MODEL WITH A HIGHER DIOPTER (17.5) WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS REPORTED AS DOING WELL AT DISCHARGE. THIS REPORT WILL CAPTURE INFORMATION FOR PATIENT¿S LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR PATIENT¿S RIGHT EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9946223 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD UNDERGONE CATARACT SURGERY WITH SYMFONY MULTIFOCAL LENS IMPLANTS IN BOTH EYES WHICH RESULTED IN BILATERAL POSITIVE DYSPHOTOPSIA, GLARE, AND STARBURSTS. INITIALLY, PLANNED EXPLANTS WERE SCHEDULED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENSES WERE EXPLANTED IN A SECONDARY SURGICAL PROCEDURE. NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES WERE REQUIRED. A DIFFERENT MODEL WITH A HIGHER DIOPTER (17.5) WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS REPORTED AS DOING WELL AT DISCHARGE. THIS REPORT WILL CAPTURE INFORMATION FOR PATIENT¿S RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR PATIENT¿S LEFT EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9946216 ↗
• InjuryFeb 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF HALOS AND GLARE FOLLOWING THE IMPLANT OF A SYMFONY INTRAOCULAR LENS (IOL). THE PATIENT OPTED NOT TO HAVE AN IOL EXCHANGE AS THE PATIENT THOUGHT HE COULD LIVE WITH THE SYMPTOMS. A LASIK PROCEDURE WAS PERFORMED, HOWEVER, AFTERWARDS THE PATIENT IS NOT SURE IF HE CAN LIVE WITH THE SYMPTOMS. ADDITIONAL INFORMATION REPORTED THE PATIENT ALSO COMPLAINED OF BLURRED VISION. THE PHYSICIAN'S OPINION IS THERE IS NOTHING WRONG WITH THE IOL. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 9663187 ↗
• InjuryJun 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE IS HAVING DIFFICULTLY ADAPTING TO HER SYMFONY LENSES IMPLANTED LAST SEPT AND OCTOBER. SHE HAS HALOS/GLARE AND HAS DIFFICULTLY WITH NIGHT DRIVING. SHE CAN'T REALLY SEE THINGS ON THE SIDE OF THE ROAD. SHE IS AN ARTIST AND EVEN THOUGH HER DOCTOR PRESCRIBED ALPHAGAN DROPS, SHE STATES THEY REALLY HAVEN'T HELP TOO MUCH. ONCE SHE ARRIVES AT HER DESTINATION; SHE WORKS UNDER BRIGHT LIGHTS AND THE RX DILATES HER EYES, MAKING IT VERY DIFFICULT FOR HER TO WORK. THIS IS AFFECTING HER DAILY ACTIVITIES. SHE HAS GONE BACK TO HER EYE SURGEON; BUT THE DOCTOR CAN'T HELP HER. DR QUOTED "I HAVE DONE 100,000 OF THESE". THE PATIENT WENT TO ANOTHER DOCTOR IN THE PRACTICE, WHO COULDN'T REALLY HELP AND THEN SHE WENT TO A THIRD DOCTOR OUT OF THE PRACTICE. THAT DOCTOR PRESCRIBED ALPHAGAN. PRIOR TO THE SURGERY, SHE WAS TOLD ALL SHE WOULD NEED IS READERS (OVER THE COUNTER) AND SHE HAS BOUGHT ABOUT 9 PAIRS THAT DON'T REALLY HELP. WHEN SHE WENT TO THE THIRD DOCTOR; HE NOTICED A LITTLE ASTIGMATISM AND ALSO SOME DRY EYE. SHE USES OVER THE COUNTER DROPS. THE EYE SURGEON SHE SAW WAS NEW TO HER AND SHE HAD A LITTLE CATARACT. IT WAS SUGGESTED SHE HAVE LASER DONE BECAUSE NOW THERE

  Patient problems: Halo; No Code Available

  MAUDE report 8746756 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 +17.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING GLARE, STARBURST AND POSITIVE DYSPHOTOPSIA. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND NO VITRECTOMY PERFORMED. REPORTEDLY LENS FROM ANOTHER MANUFACTURER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS HAPPY WITH RINGS AND STARBURST GONE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8601838 ↗
• InjuryApr 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT FOLLOWING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN HER RIGHT EYE, SHE IS EXPERIENCING PROBLEMS WITH LIGHT EFFECTS, ESPECIALLY ON THE RIGHT SIDE AND DIFFICULTY DISTINGUISHING COLOR HUES. ADDITIONAL INFORMATION RECEIVED REVEALED THE PATIENT HAS UNDERGONE A YAG PROCEDURE AND MEDICAL INTERVENTION TO ADDRESS HER SYMPTOMS. THE SYMPTOMS AFFECT THE PATIENTS ABILITY TO PERFORM DAILY ACTIVITIES. SHE TRIES NOT TO DRIVE AT NIGHT DUE TO THE GLARE AND FIREWORKS SHE SEES WITH HER RIGHT EYE. THE SYMPTOMS STARTED ALMOST IMMEDIATELY BUT THERE ARE NO VISUAL ACUITY ISSUES. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8532309 ↗
• InjuryDec 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS COMPLAINING OF DEPTH PERCEPTION AND GLARE AFTER IMPLANTATION OF A MODEL ZXR00 17.0 DIOPTER TECNIS MULTIFOCAL IOL (INTRAOCULAR LENS). AS A RESULT, THE IOL WAS EXPLANTED AND REPLACED WITH A MODEL ZCB00 20.0 DIOPTER LENS. PATIENT IS DOING WELL POST EXCHANGE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8197925 ↗
• InjuryOct 18, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +17.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE BECAUSE OF PATIENT EXPERIENCING BLURRY VISION, NOT HAPPY WITH THE VISION, VISION COMPLAINTS NOT CLEAR, AND THE LENS WAS NOT CENTERED. THERE WAS INCISION ENLARGEMENT PERFORMED DURING THIS PROCEDURE. REPORTEDLY, A MONOFOCAL INTRAOCULAR LENS WAS USED AS THE REPLACEMENT IOL FOR THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7982511 ↗
• InjuryOct 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 17.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. POST-OPERATIVELY, THE PATIENT COMPLAINED OF BLURRED VISION, SENSITIVITY TO LIGHT DURING SUNNY AND CLOUDY DAYLIGHT HOURS, AND STARBURSTS DURING THE NIGHT. THEREFORE, THE PATIENT WAS REFERRED TO A SECOND DOCTOR FOR A SECOND OPINION WHO HAS SCHEDULED AN EXPLANT TO BE PERFORMED ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 7942333 ↗
• InjurySep 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO A NEGATIVE DYSPHOTOPSIA. THE REPLACEMENT LENS WAS A ZCB00 17.0 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 RIGHT EYE.

  Patient problems: No Code Available

  MAUDE report 7857117 ↗
• InjuryJul 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT HAD BILATERAL SYMFONY INTRAOCULAR LENS (IOL) IMPLANTATION. (RIGHT EYE: ZXR00 +17.0 DIOPTER ON (B)(6) 2017 - LEFT EYE: ZXR00 +18.0 DIOPTER ON (B)(6) 2018). ONE-MONTH AFTER THE IMPLANTATION OF THE IOL INTO THE LEFT EYE, THE PATIENT HAD INFLAMMATION AFTER WEANING OFF HER DROPS. SHE WAS THEN STARTED ON ANOTHER PREDNISOLONE WEAN. SINCE THEN, SHE HAS HAD A MILD 1-2+ CELL RECURRENT UVEITIS, AND SHE WAS ON A SLOW (EVERY 2 WEEKS) DUREZOL WEAN. SHE ALSO DEVELOPED UVEITIS IN THE RIGHT EYE AFTER DOING A YAG (YTTRIUM ALUMINIUM GARNET) CAPSULOTOMY IN (B)(6) 2018 AND SHE STARTED SLOW DUREZOL WEAN ALSO IN THE RIGHT EYE. THE SURGEON COMMENTED THAT THERE WAS NOTHING SPECIAL ABOUT HER POSTERIOR CAPSULE OPACIFICATION. IT DIDN'T APPEAR LIKE A CHRONIC ENDOPHTHALMITIS, AND THE LEFT POSTERIOR CAPSULE WAS CLEAR. SHE HAS NO HISTORY OF UVEITIS PRIOR TO PHACO, AND HER UVEITIS LABS AND CHEST X-RAY ARE NORMAL. THE PATIENT COMPLAINS OF HAZY VISION, PAIN AND GLARE. WITHOUT THE DUREZOL, SHE CANNOT OPEN HER EYES DUE TO THE PHOTOPHOBIA. HER VISION IS GREAT WHEN THE UVEITIS IS CALM. THIS REPORT IS TO RECORD THE LENS IMPLANTED IN THE RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR

  Patient problems: No Code Available; Uveitis

  MAUDE report 7697603 ↗
• InjuryMar 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +17.0 DIOPTER) WAS IMPLANTED IN PATIENT'S OPERATIVE EYE ON (B)(6) 2017. REPORTEDLY IT WAS LATER SCHEDULED TO BE EXPLANTED ON (B)(6) 2018 IN A SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING GLARE. TARGET REF -0.12, SANS CORRECTION VISUAL ACUITY (SCVA) 1 DAY POSTOP WAS 20/40 +2 CHIEF COMPLAINT (CC) SHADOW IN LOWER HALF OF VISION, SCVA 6 DAY POSTOP 20/20 J3 NO COMPLAINTS, SCVA 2 MONTHS POSTOP 20/25 J4 CC TERRIBLE GLARE BOTH DAY AND NIGHT MANIFEST REFRACTION (MR) PL-0.50×160 20/20, SCVA 3 MONTHS POSTOP 20/20-2 J3 CC GLARE, UNABLE TO DRIVE AT NIGHT, MR-0.75-0.25×172 20/20, SCVA 3-AND-A-HALF-MONTH POST OP 20/25-1 J3 CC GLARE IS UNBEARABLE, DAY AND NIGHT. MR -0.25-0.50×165 20/20. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7367414 ↗
• InjuryNov 27, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXR00 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, BECAUSE OF A REFRACTIVE ERROR. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER OF 19.0. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING GOOD POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7062231 ↗
• InjuryOct 23, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZXR00 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED DUE TO A MALFUNCTION. THE LENS WAS REPLACED WITH MODEL ZCB00, BUT THE DIOPTER WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6970660 ↗
• InjuryOct 13, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXR00 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2016. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO THE PATIENT EXPERIENCING HAZY VISION AND HYPEROPIA. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER OF 18.0. REPORTEDLY, THE PATIENT IS DOING OKAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6950369 ↗
• InjurySep 25, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXR00 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED ON (B)(6) 2017 DUE TO A POST-OPERATIVE SPHERICAL EQUIVALENT (SE) OUTCOME OF -.75, WHICH REPORTEDLY CAUSE THE PATIENT TO EXPERIENCE HALOS. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY. THE PATIENT WAS UNAFFECTED. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER OF 16.0. FURTHER INFORMATION WAS PROVIDED IN FOLLOW UP. IT WAS NOTED THAT THE SURGEON MISSED TARGET, INCORRECT POWER SELECTED WHICH ALSO RESULTED IN UNEXPECTED POST-OP REFRACTION. THE SYMPTOMS INTERFERED WITH THE PATIENT'S DAILY ACTIVITIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6889449 ↗
• MalfunctionSep 7, 2017Crack; Crack

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S EYE AND IT LOOKED LIKE IT WAS CRACKED. REPORTEDLY, THE LENS WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6847549 ↗
• InjuryAug 10, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXR00 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S LEFT EYE DUE TO SUBLUXATION OF THE IOL. THERE WAS NO VITRECTOMY AND NO INCISION ENLARGEMENT REQUIRED. ADDITIONALLY, THERE WAS NO PATIENT CONSEQUENCE. THE LENS WAS REPLACED WITH A DIFFERENT MODEL AND A LOWER DIOPTER SIZE LENS. DURING THE LAST FOLLOW UP PATIENT WAS J1+ 20/20 -3. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6786956 ↗
• InjuryJun 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 TECNIS SYMFONY INTRAOCULAR LENS (IOL) WAS EXPLANTED AS PATIENT COMPLAINED OF VISUAL DISTORTION AND WAS NOT HAPPY WITH THE LENS. THE SYMFONY LENS WAS REPLACED WITH A ZCB00, 17.5 DIOPTER. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6682058 ↗
• InjuryMay 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAN A ZXR00 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY PROCEDURE FROM THE LEFT EYE OF A MALE PATIENT. THE LENS WAS REPLACED WITH A MODEL Z9002 OF THE SAME DIOPTER (17.0). NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 6546684 ↗
• InjuryApr 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL SYMFONY INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE OF A MALE PATIENT. REPORTEDLY, THE LENS WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF POOR OUTCOME OF J7, VISUAL ACUITY 20/63. THE EXPLANTED SYMFONY LENS WAS DISCARDED BY THE CUSTOMER, AND IT WAS REPLACED WITH A MULTIFOCAL ZMB00, DIOPTER UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 6483786 ↗
• InjuryJan 10, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A FEMALE PATIENT HAD A LATMF (LEFT EYE TECNIS MULTIFOCAL LENS) FIRST EYE. SHE WAS VERY HAPPY WITH HER VISION BUT WANTED A BIT MORE DISTANCE VISION. THE PHYSICIAN DECIDED TO IMPLANT A SYMFONY IN THE SECOND EYE. THE POST-OP TARGET WAS PLANO BUT THE OUTCOME ENDED UP BEING -1.50. THE PHYSICIAN NOTED THAT HE USED THE CORRECT A-CONSTANT. THE SURGERY RESULTED IN AN UNEXPECTED MYOPIC OUTCOME. THE PATIENT WAS NOT HAPPY WITH THE RESULTS AND THE PHYSICIAN IS PLANNING ON EXPLANTING THE LENS AND REPLACING IT WITH A DIFFERENT POWER. THROUGH FOLLOW UP IT WAS LEARNED THAT THE SYMFONY LENS IMPLANTED IN THE SECOND EYE WAS REPORTEDLY A +20.0 DIOPTER. THIS LENS WAS EXPLANTED AND REPLACED WITH A REPORTEDLY +17.0 DIOPTER LENS. AFTER THE EXCHANGE THE PATIENT ENDED UP WITH +1.50. WITH THIS RESULT THE PHYSICIAN IS NOW CONSIDERING EXPLANTING THE 17.0 DIOPTER LENS AS HE MAY HAVE MADE TOO MUCH OF AN ADJUSTMENT. FURTHER FOLLOW UP CONFIRMED THAT THIS 17.0 DIOPTER LENS WAS EXPLANTED. THIS REPORT WILL CAPTURE THE SYMFONY +17.0 DIOPTER LENS AND A SEPARATE REPORT WILL BE FILED FOR THE +20.0 DIOPTER LENS.

  Patient problems: No Code Available

  MAUDE report 6239793 ↗