TECNIS IOL ZXR00 (REF ZXR00U0250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 05050474579194), received between Nov 3, 2016 and Apr 21, 2023 — classified as 27 injuries, 2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ZXR00 INTRAOCULAR LENS WAS EXPLANTED DUE TO MECHANICAL FAILURE. VITRECTOMY WAS DONE, NEW INCISION AND INCISION ENLARGED. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE DIAGNOSIS FOR EXPLANTATION WAS MECHANICAL FAILURE THAT THE PATIENT REPORTED CONSTANT BLURRED VISION AND GLARE WITH ALL DAILY ACTIVITIES. THE ZXR00 LENS WAS REPLACED WITH ZMA00, LENS POWER +24.00/+4D ADD. PATIENT IS STABLE POST OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 16792449 ↗
• InjuryApr 7, 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 FOR UNKNOWN REASON. THE IOL IS NOT RETURNING FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 16702618 ↗
• InjuryMay 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THE PATIENT A PATIENT WAS NOT HAPPY WITH THEIR OUTCOME POST-IMPLANT OF A TORIC INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. THE LENS WAS SUBSEQUENTLY EXPLANTED, NO VITRECTOMY WAS REQUIRED. THE PATIENT WAS REPORTED TO BE FULLY RECOVERED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT WAS UNHAPPY DUE TO POOR QUALITY OF VISION WITH THE MULTIFOCAL IOL. THE PATIENT COMPLAINED OF SEEING RINGS EVERYWHERE DURING THE DAY AND AT NIGHT. THE EXPLANTED LENS WAS REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS (MODEL ZA9003 AND LOWER DIOPTER 23.5). THE EXPLANTED LENS WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 11904418 ↗
• InjuryJan 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT (OS) EYE DUE TO POOR REFRACTIVE OUTCOME - HIGH MYOPIC OUTCOME. THE PATIENT WAS NOT HAPPY WITH HER VISION SINCE DAY 1 POST-OPERATION. THE REPLACEMENT LENS IS A MODEL ZA9003, 23.5 DIOPTER LENS. IT IS NOTED THAT THE PATIENT'S VISION HAS IMPROVED. THE CUSTOMER ALSO INDICATED THAT THE LENS HAS BEEN DISCARDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 11143900 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INTRAOCULAR LENS (IOL) IMPLANT IN THE RIGHT EYE. THE DOCTOR WAS AIMING FOR PLANO, BUT THE PATIENT CAME OUT TO BE A -1.75 SPH 20/20. THEY REPEATED MEASUREMENTS AND RAN DIFFERENT METHODS BUT STILL CANNOT FIGURE OUT WHAT CAUSED THE DRIFT. THE PATIENT CANNOT SEE AT ALL AT A DISTANCE AND NOT SEEING REAL CLEAR AT NEAR. IT WAS LEARNED THAT THE LENS WAS SUBSEQUENTLY EXPLANTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10639564 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THE IOL WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO A MYOPIC MISS. THE IOL WAS REPLACED WITH MODEL ZXR00 21.5 DIOPTER. THE PATIENT HAS A PREVIOUS PRK -1.93 DIOPTER MYOPIC MISS. THE CUSTOMER REPORTED THERE WERE NO COMPLICATIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY, SUTURES OR CAPSULAR TEAR. REPORTEDLY, THE PATIENT IS DOING WELL POSTOP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10480703 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (MODEL ZXR00 25.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE DUE TO DOUBLE VISION AND ANISOMETROPIA ISSUES. THERE WAS A SLIGHT INCISION ENLARGEMENT REQUIRED. A REPLACEMENT LENS (MODEL ZXT150 23.0 DIOPTER) WAS USED. REPORTEDLY, THE PATIENT IS DOING OK; HOWEVER, THE ACCOUNT HAS NOT SEEN THE PATIENT SINCE THE LENS WAS EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9887299 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO GLARE. SUSPECT LENS WAS DISCARDED. IT WAS STATED THAT THERE WAS NO PATIENT INJURY. IT WAS LEARNED THAT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES PERFORMED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9846270 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE ON (B)(6) 2019. AT 1 WEEK POSTOP, VISUAL ACUITY WAS 20/40. THE LENS WAS EXPLANTED ON (B)(6) 2019, DUE TO POOR VISION QUALITY AS A RESULT OF IRREGULAR ASTIGMATISM AND OCULAR SURFACE DISEASE. A MONOFOCAL REPLACEMENT LENS, MODEL ZA9003 25.0 DIOPTER, WAS IMPLANTED. THERE WAS NO MEDICAL INTERVENTION, SUTURES, OR INCISION ENLARGEMENT REQUIRED, AND THE PATIENT IS DOING FINE POST OPERATIVELY. BEST CORRECTED VISUAL ACUITY IS 20/25 AT ONE WEEK POST SURGERY. CUSTOMER ALSO INDICATED THAT THE LENS WAS DISCARDED AT THE FACILITY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8808851 ↗
• InjuryJun 21, 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 +25.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING HYPEROPIC MISS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. REPORTEDLY LENS WITH SAME MODEL BUT A LOWER DIOPTER (+22.0) WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8720999 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A PATIENT IMPLANTED WITH A SYMFONY INTRAOCULAR LENS (IOL) MORE THAN 2.5 YEARS AGO WAS NOT SATISFIED WITH HER VISION SINCE THE ORIGINAL SURGERY. TOPOGRAPHY SHOWS A SOMEWHAT DECENTERED ABLATION WHICH MAY BE A FACTOR AS TO WHY THE PATIENT HAS NOT BEEN SATISFIED WITH HER VISION. THE PATIENT DOES HAVE VISUALLY SIGNIFICANT POSTERIOR CAPSULAR OPACIFICATION (PCO) WITH AN INTACT CAPSULE. IT WAS NOTED THERE WAS NO CLINICALLY RELEVANT OCULAR SURFACE ISSUES AND RETINA IS NORMAL. ADDITIONAL INFORMATION RECEIVED REVEALED THE PATIENT COMPLAINED OF VISION NOT CRISP DISTANCE OR NEAR NOTED AT 1-WEEK POST WHEN INTRAOCULAR PRESSURE (IOP) WAS 34. BETTER AT 2 MONTHS, WORSE AGAIN AT 3 MONTHS. PATIENT STILL UNHAPPY WITH NIGHT DRIVING AND STARBURST. THE PATIENT HAD PRIOR LASIK - GOOD CENTRATION OF LASIK ABLATION ON PRE SYMFONY PLACEMENT, RECENT TOPOGRAPHY PRE-OP FOR EXPLANT USING GALILEI CONSISTENT WITH MILD-MODERATE DECENTERED ABLATION. PRIOR TO KPE (KELMAN PHACOEMULSIFICATION) THE ASTIGMATISM WAS 0.15 D OF ATR (AGAINST-THE-RULE) AT APPROXIMATELY 10 DEGREES. FEMTO SECOND LASER WAS USED AND THERE WERE NO COMPLICATIONS WITH EITHER LASER OR CATARACT/IOL PORTIONS OF THE PROCEDUR

  Patient problems: Corneal Edema; Intraocular Pressure Increased; Visual Disturbances

  MAUDE report 8553328 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY INTRAOCULAR LENS (IOL), MODEL ZXR00, 25.0 DIOPTER, WAS EXPLANTED FROM THE LEFT EYE (OS) AS THE PATIENT WAS UNABLE TO SEE CLEARLY /FOCUS AND DUE TO UNEXPECTED POSTOP REFRACTION WHICH AFFECTED THE PATIENT'S DRIVING. REPORTEDLY, THE OUTCOME SIGNIFICANTLY INTERFERED WITH THE PATIENT'S DAILY LIFE ACTIVITIES. A REPLACEMENT LENS OF THE SAME MODEL, BUT DIFFERENT DIOPTER (24.0) WAS USED. THERE WAS NO INCISION ENLARGEMENT REQUIRED. IT WAS INDICATED THAT THE PATIENT HAS RECOVERED AND NO PATIENT INJURY WAS REPORTED. THE EXPLANTED LENS WAS DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8512921 ↗
• InjuryMar 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A MODEL ZXR00, 25.0 DIOPTER INTRAOCULAR LENS (IOL) IS SCHEDULED FOR EXPLANT, BECAUSE THE PATIENT IS HAVING VISUAL ISSUES, VISION NOT CORRECTED RIGHT. FURTHER INFORMATION WAS PROVIDED, AND IT WAS LEARNT THAT THE CUSTOMER MEASURED AN IOL OF 25 AND THE PATIENT TURNED OUT -3.25 + 0.50 X 55. THE PATIENT WAS 20/150 UNCORRECTED VISUAL ACUITY (UCVA) FROM DAY ONE POST-OP. IT WAS ALSO REPORTED THAT THE VISUAL SYMPTOMS SIGNIFICANTLY INTERFERE WITH THE PATIENT¿S REGULAR ACTIVITIES. THE LENS WAS EXPLANTED AS PLANNED. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED AT EXPLANT. IT WAS NOTED AT DAY ONE POST-OP THERE WAS A LOT OF SWELLING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Swelling

  MAUDE report 8381001 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT REPORTED THAT SHE HAD A SYMFONY MULTIFOCAL INTRAOCULAR LENS (IOL) IMPLANTED ON (B)(6) 2017 AND COMPLAINED OF CONCENTRIC CIRCLES (HALOS) AND STARBURSTS WHICH DISTORTED HER VISION AND AFFECTED HER ABILITY TO SAFELY DRIVE AFTER DARK. THE PATIENT REPORTED HER VISION IS SATISFACTORY NOW THAT THE REPLACEMENT HAS BEEN PERFORMED. ADDITIONAL INFORMATION REVEALED THAT THE IOL WAS EXPLANTED ON (B)(6) 2018 FROM HER LEFT EYE (OS) AND REPLACED WITH A MONOFOCAL NON-JOHNSON AND JOHNSON IOL. THERE WAS NO INCISION ENLARGEMENT, NO INJURIES AND NO ADDITIONAL MEDICAL OR SURGICAL PROCEDURES WERE PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8239849 ↗
• InjuryNov 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXR00 +25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE ON (B)(6) 2018. REPORTEDLY, THE LENS WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO THE PATIENT COMPLAINING OF HORRIBLE HALOS. A ZCB00 +24.5 DIOPTER LENS WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED DOING FINE WITH NO COMPLAINTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8077024 ↗
• InjuryAug 6, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 +25.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE IN SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING MYOPIC SURPRISE. REPORTEDLY SURGEON MISCALCULATED. LENS WITH MODEL ZXR00 +22.5 DIOPTER WAS USED AS REPLACEMENT LENS FOR THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT AFTER THE INITIAL SURGERY PATIENT WAS SEEN IN CLINIC AND HAD BEEN DISSATISFIED WITH DISTANCE VISION. DURING THE EXPLANT PROCEDURE INCISION ENLARGEMENT WAS PERFORMED. PATIENT IS DOING GREAT AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7753770 ↗
• InjuryMay 16, 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, +25.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE IN A SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING DOUBLE VISION AND BLURRY VISION. THE LENS WAS REPLACED WITH MODEL ZXT300, +26.5 DIOPTER. REPORTEDLY THERE WAS NO INCISION ENLARGEMENT, NO PATIENT INJURY AND NO VITRECTOMY. PATIENT WAS FINE AT DISCHARGE AND REPORTEDLY IT WAS LESS THAN 24 HOURS SO PATIENT STILL FELT VISION WAS BRIGHT AND HAD IMPROVED FROM PRE-OP VISION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7521088 ↗
• InjuryJan 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, BECAUSE THE LENS POWER WAS WRONG FOR THE PATIENT. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE REPLACEMENT LENS WAS A MONOFOCAL ZA9003 25.5 DIOPTER LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY, BUT THE PATIENT WAS EXPERIENCING BLURRED VISION AT ALL RANGES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7181063 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, BECAUSE THE PATIENT WAS EXTREMELY UNHAPPY WITH NIGHTTIME DIFFICULTIES, INCLUDING EXTREME HALOS AND GLARE. REPORTEDLY, THE PATIENT FELT DISABLED BY THESE SYMPTOMS. THE DOCTOR ATTEMPTED TO LESSEN THE PATIENT'S SYMPTOMS BY PERFORMING A YTTRIUM-ALUMINUM GARNET (YAG) CAPSULOTOMY, INCLUDING PRESCRIBING NIGHT DRIVING GLASSES, BUT BOTH ATTEMPTS WERE UNSATISFACTORY TO THE PATIENT. THERE WAS NO VITRECTOMY PERFORMED DURING IMPLANTATION OR EXPLANTATION PROCEDURES, BUT THE INCISION SITE WAS ENLARGED FROM 2.2MM TO 2.75MM AT LENS EXPLANT. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7163039 ↗
• InjuryDec 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 25.0 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 TO GOING FROM A MULTIFOCAL TO A NON MULTIFOCAL LENS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR CAPSULE TEAR. THE LENS WAS REPLACED WITH A ZCB00 WITH A LOWER DIOPTER IOL. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING WELL POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDE.

  Patient problems: No Code Available

  MAUDE report 7089530 ↗
• InjuryNov 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE PATIENT COMPLAINED OF WORSE VISION AFTER SURGERY. REPORTEDLY, THE SURGERY WENT WELL WITH NO ISSUES OR COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7039823 ↗
• InjuryNov 6, 2017Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZXR00 25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO A MECHANICAL COMPLICATION AND REFRACTIVE SURPRISE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER (22.5). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7003738 ↗
• InjuryAug 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD THE INTRAOCULAR LENS EXPLANTED. NO REASON FOR THE EXPLANT WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6793454 ↗
• InjuryJul 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A SYMFONY INTRAOCULAR LENS (IOL) IS HAVING A GREAT DEAL OF ISSUES WITH GLARE. AFTER PATIENT'S FOLLOW-UP VISIT, THE PHYSICIAN IS CONSIDERING POSSIBLY STARTING THE PATIENT ON RESTASIS. THROUGH FOLLOW-UP IT WAS LEARNED THAT A ZXR00 25.0 DIOPTER IOL WAS IMPLANTED IN THE PATIENT'S RIGHT EYE. THE PROBLEM OCCURRED AT POST-OP DAY ONE IN BOTH EYES. THE LENS REMAINS IMPLANTED. PATIENT STILL HAS COMPLAINTS OF GLARE AND STARBURSTS; SAYS THEY'RE DIMMER, BUT STILL THERE. THIS REPORT WILL CAPTURE THE LENS IN THE RIGHT EYE AND A SEPARATE REPORT WILL CAPTURE LEFT EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6714659 ↗
• InjuryJul 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A SYMFONY INTRAOCULAR LENS (IOL) IS HAVING A GREAT DEAL OF ISSUES WITH GLARE. AFTER THE PATIENT'S FOLLOW-UP VISIT, THE PHYSICIAN IS CONSIDERING POSSIBLY STARTING THE PATIENT ON RESTASIS. THROUGH FOLLOW-UP IT WAS LEARNED THAT A ZXR00 25.0 DIOPTER IOL WAS IMPLANTED IN THE PATIENT'S LEFT EYE. THE PROBLEM OCCURRED AT POST-OP DAY ONE IN BOTH EYES. THE PHYSICIAN PERFORMED YAG (YTTRIUM ALUMINIUM GARNET) ON THIS EYE. THE LENS REMAINS IMPLANTED. PATIENT STILL HAS COMPLAINTS OF GLARE AND STARBURSTS; SAYS THEY'RE DIMMER, BUT STILL THERE. THIS REPORT WILL CAPTURE THE LENS IN THE LEFT EYE AND A SEPARATE REPORT WILL CAPTURE RIGHT EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6714656 ↗