TECNIS IOL DFR00V (REF DFR00VU190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 05050474750654), received between Jan 31, 2022 and Feb 26, 2024 — classified as 25 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2024Break; Ejection Problem; Break; Ejection Problem

  IT WAS REPORTED THAT THREE JOHNSON AND JOHNSON INTRAOCULAR LENSES (IOLS) DID NOT WORK RIGHT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO CAPTURE THE FIRST LENS EVENT. SEPARATE REPORTS WILL BE SUBMITTED TO CAPTURE THE SECOND AND THIRD LENS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784675 ↗
• InjuryOct 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER INSERTING THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED BLURRINESS ON PERIPHERAL WITH LACK OF FOCUS. THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JNJ LENS (ALCON VIVITY LENS). THE PATIENT WAS NOT INJURED AND THERE WERE NO COMPLICATIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR PRESCRIBED MEDICATION. THE PATIENT¿S OUTCOME IS VERY CLEAR VISION AND THEY¿RE HAPPY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 17982146 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS SYNERGY SIMPLICITY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT RIGHT EYE DURING SECONDARY SURGERY DUE TO VISION DISTURBANCES AND HALOS. DIRECTIONS FOR USE WERE FOLLOWED. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND VITRECTOMY WAS NOT REQUIRED. THE DFR00V LENS WAS REPLACED WITH DIB00 LENS. PATIENT WAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 17901738 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO MECHANICAL FAILURE. THE MECHANICAL FAILURE WAS DESCRIBED AS PATIENT COMPLAINED OF BLURRED VISION. THE EXPLANTED IOL WAS REPLACED WITH AAB00 +18.50 DIOPTER POWER SIZE IOL. THERE WAS INCISION ENLARGEMENT, BUT THERE WAS NO VITRECTOMY, NO SUTURES, NO PATIENT POST-OP INJURY. IT WAS LEARNED THAT THE REPLACEMENT IOL ADDRESSED THE PATIENT'S VISUAL ISSUES WITH GOOD SURGICAL OUTCOME AND THE PATIENT REPORTS IMPROVED VISION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 17865846 ↗
• InjuryApr 25, 2023Break; Device Difficult to Setup or Prepare; Material Split, Cut or Torn; Break; Device Difficult to Setup or Prepare; Material Split, Cut or Torn

  IT WAS REPORTED THAT A SYNERGY INTRAOCULAR LENS (IOL) IMPLANT NEEDED TO BE REMOVED AND REPLACE WITH ANOTHER ONE DUE TO A ¿TEAR NEAR THE CENTER¿. IT WAS CONFIRMED THAT THE LENS WAS INSERTED, REMOVED AND A BACKUP LENS WAS INSERTED THE SAME DAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16804645 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD HER BILATERAL INTRAOCULAR LENSES (IOLS) EXPLANTED BY ANOTHER SURGEON. PATIENT HAD BEEN EXPERIENCING GLARE AND HALOS, STARBURSTS AROUND LIGHTS AT NIGHT AND SPIKES AND ALL SORTS OF REFRACTION ISSUES AND EYESIGHT HAS DETERIORATED OVER TIME AND COULD NOT SEE 15 FEET IN FRONT OF HER. NIGHT DRIVING FROM GLARE IS BLINDING AND IMPOSSIBLE TO DRIVE AT NIGHT. ALL LIGHTS, HEADLIGHTS, TAILLIGHTS, STREETLIGHTS, HOUSE LIGHTS ALL HAD A COMBINATION OF HALOS, SPIRALS, STARBURSTS, AND FERRIS WHEELS. SOUTHERN EYE CENTER REMOVED BOTH IOLS RECENTLY. PATIENT IS LOOKING TO GET REIMBURSEMENT FROM PHYSICIAN BUT HAS NOT TOLD PHYSICIAN YET. IT WAS LEARNED THAT THE EXPLANTED IOLS WERE REPLACED WITH NON-JOHNSON AND JOHNSON IOLS. CUSTOMER SAID THAT HER VISION IS A LOT BETTER THAN WHEN SHE HAD THE OLD LENSES. CUSTOMER CONFIRMED THAT SHE HAS BOTH EXPLANTED IOLS WITH HER AND WILL GIVE THEM TO HER IMPLANT DOCTOR ONLY IF SHE WILL REIMBURSE HER WITH HER EXPENSES. OTHERWISE, SHE WILL NOT RETURN THE PRODUCTS FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES EVENT FOR RIGHT EYE, A SEPARATE REPORT IS SUBMITTED FOR THE OTHER EYE (LEFT EYE).

  Patient problems: Flashers; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 16766189 ↗
• InjuryFeb 1, 2023Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  IT WAS REPORTED THE DFR00V 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S OPERATIVE EYE. THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF DIOPTER MISS AND REPLACED WITH A DFR00V 19.5 LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 16279468 ↗
• MalfunctionJan 11, 2023Crack; Crack

  IT WAS REPORTED WHILE IMPLANTING PRE-LOADED DFR00V INTRAOCULAR LENS (IOL) THE TIP OF THE INJECTOR SPLIT AND THE LENS STARTED COMING OUT THE SIDE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16142902 ↗
• InjuryDec 15, 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 OPERATIVE EYE IN A SECONDARY SURGICAL PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 15993010 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JNJ INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO THEM EXPERIENCING HALOS AND BLURRY VISION. THEIR PRE-OPERATIVE VISUAL ACUITY WAS 20/60 AND POST-OPERATIVE 20/30. THE INCISION HAD TO BE ENLARGED. THERE WERE NO SUTURES USED, NO VITRECTOMY REQUIRED AND NO DELAY IN PROCEDURE. REPORTEDLY, THE PATIENT IS DOING WELL AFTER THE EXPLANT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 15974338 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO MECHANICAL FAILURE OF THE MULTIFOCAL, RESULTING IN CONSTANT HAZY, BLURRY VISION AT DISTANCE AND NEAR WITH HALOS AROUND ALL LIGHTS CAUSING BLURRED VISION WITH DRIVING, AND WAS REPLACED WITH A Z9002 18.0 DIOPTER IOL. THERE WAS NO PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY HOWEVER, THE INCISION WAS ENLARGED. PATIENT OUTCOME POST LENS EXCHANGE WAS REPORTED AS STABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 15971630 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DFR00V 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF MECHANICAL FAILURE AND REPLACED WITH AN AAB00 21.0 DIOPTER IOL. MECHANICAL FAILURE WAS CLARIFIED AS PATIENT REPORTING GLARE AND BLURRED VISION INTERFERING WITH DRIVING SAFELY AT NIGHT. THERE WAS NO PATIENT INJURY, NO SUTURE(S) AND NO VITRECTOMY HOWEVER, THE INCISION WAS ENLARGED. PATIENT OUTCOME POST LENS EXCHANGE WAS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 15964894 ↗
• InjuryNov 30, 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 THE PATIENT'S OPERATIVE EYE DUE TO A MECHANICAL COMPLICATION-HALOS. THE VISUAL ACUITY (VA) PRE-OPERATIVE: 20/50 AND VA POST-OPERATIVE: 20/20. THE INCISION WAS ENLARGED AND SUTURES AND A VITRECTOMY WERE REQUIRED. THE PATIENT IS DOING WELL POST-OPERATIVELY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 15886770 ↗
• InjuryNov 22, 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 THE PATIENT'S RIGHT EYE DUE TO HALOS. VISUAL ACUITY (VA) PRE-OPERATIVE (OP): 20/40 AND VA POST-OP: 20/20. THERE WAS NO VITRECTOMY OR SUTURES REQUIRED, HOWEVER, THE INCISION WAS ENLARGED. ANOTHER JOHNSON & JOHNSON LENS, MODEL ZCB00 19.0 DIOPTER, WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING WELL AFTER IOL EXCHANGE AS THE HALOS HAVE RESOLVED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo

  MAUDE report 15848333 ↗
• InjuryOct 31, 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 DUE TO MECHANICAL FAILURE. THE ACCOUNT CLARIFIED THAT BY MECHANICAL FAILURE, THEY MEANT THAT HALOS AND SHADOWS AROUND VISION DURING THE DAY AND EVENING MAKING IT DIFFICULT TO DRIVE. IT WAS CONFIRMED THAT THE PATIENT DID NOT HAVE ANY PRE-EXISTING ISSUE WHICH CONTRIBUTED TO THE REPORTED ISSUES. THE INCISION WAS ENLARGED, AND THE LENS WAS TAKEN OUT IN WHOLE. NO OTHER SURGICAL INTERVENTIONS WERE REQUIRED. ANOTHER JOHNSON AND JOHNSON LENS OF A DIFFERENT MODEL AND DIOPTER (AAB00 +19.50) WAS USED AS A REPLACEMENT. THE PATIENT IS STABLE, AND NO INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 15705333 ↗
• InjuryOct 13, 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 IMPLANTED INTO THE PATIENT'S OCULAR DEXTER (RIGHT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED AND REPLACED WITH A DIFFERENT LENS MODEL WITH A LOWER DIOPTER SIZE (LENS MODEL Z9002, 18.0 DIOPTER) DUE TO COMPLAINTS OF PATIENT UNABLE TO ADAPT TO THE MULTIFOCAL DESIGN AND EXPERIENCING CONSTANT FOGGY, HAZY VISION WITH ALL DAILY ACTIVITIES. THERE WAS NO PATIENT INJURY AND NO SUTURE(S); HOWEVER, THE INCISION WAS ENLARGED AND A VITRECTOMY WAS PERFORMED. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS STABLE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 15602019 ↗
• InjuryAug 25, 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 LEFT EYE BECAUSE PATIENT IS BOTHERED BY LOSS OF CONTRAST AND POOR VISUAL ACUITY QUALITY. PL-0.50X30 20/20. PRE-OP VISUAL ACUITY: 20-30 -1. THE PATIENT WAS ADAMENT ABOUT REMOVING THE LENS, VERY POOR VISION FOR DISTANCE. THE INCISION WAS ENLARGED; HOWEVER, NO OTHER SURGICAL INTERVENTIONS WERE REQUIRED. THE EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. POST-EXPLANT POST-OP VISUAL ACUITY: 20/20. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 15299348 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DOCTOR PERFORMED A SYNERGY LENS EXCHANGE OF THE LEFT EYE OF A PATIENT FOR REDUCTION OF SIDE EFFECTS. PATIENT EXPERIENCED PERSISTENT HALOS AND GLARE AROUND POINTS OF LIGHT WHICH LED TO THE EXPLANT. A NON-JOHNSON AND JOHNSON LENS WAS USED AS THE REPLACEMENT. NO PATIENT INJURY OR OTHER INTERVENTIONS REPORTED. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 15161907 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WAS IMPLANTED WITH A SYNERGY INTRAOCULAR LENS (IOL) THREE MONTHS AGO. THE QUALITY OF THE PATIENT'S VISION HAS BEEN POOR SINCE THE SURGERY, AND WORSE THAN PRE-OPERATIVE (OP). SURGEON CAN GET HER TO 20/25 VERY SLOWLY, BUT WORSE THAN PRE-OP AND WORSE THAN LEFT EYE (OS) WITH CATARACT. SURGEON CANNOT FIND ANYTHING WRONG WITH THE EYE, AND PLANS ON DOING A LENS EXCHANGE. CORNEA: PATIENT HAD LASIK, BUT CORNEA WAS CLEAR WITH NORMAL MIRES, AND SPHERICAL. THE IMPLANT IS WELL CENTERED, OPTICAL COHERENCE TOMOGRAPHY (OCT) IS NORMAL MACULA, THE CAPSULE IS MILD OPACITY WHICH IS NOT SIGNIFICANT, AND THE SURGEON DOES NOT WANT TO DO A YTTRIUM ALUMINUM GARNET (YAG) IF THEY ARE GOING TO EXCHANGE THE LENS. THROUGH FOLLOW-UP, IT WAS LEARNED THE IOL WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE. ANOTHER JOHNSON & JOHNSON LENS, MODEL DIB00 19.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort

  MAUDE report 14881806 ↗
• InjuryJun 27, 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 THE PATIENT'S LEFT EYE DUE TO THE PATIENT WAS EXPERIENCING HALOS AND RINGS. THE PATIENT COMPLAINED OF POOR VISION AND HALOS INTERFERING WITH NIGHT DRIVING AND GOLFING. THE INCISION WAS ENLARGED DURING THE EXPLANT. ANOTHER JOHNSON & JOHNSON AAB00 LENS (DIFFERENT MODEL AND 20.0 DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS STATED TO HAVE A GOOD POST-OPERATIVE OUTCOME AND THE PATIENT IS NOTICING IMPROVED VISION. STABLE POST-OPERATIVE FINDINGS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 14838039 ↗
• InjuryJun 15, 2022Adverse 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 PATIENT'S LEFT EYE AFTER EXPERIENCING BLUR, GLARE, AND HALOS, DAY-ONE AFTER SURGERY. THE PATIENT WAS UNABLE TO DRIVE DUE TO THE VISUAL ISSUES. THERE WAS NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION AND NO PATIENT INJURY. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, DIU150, SAME DIOPTER). THE PATIENT IS HAPPY AND DOING MUCH BETTER. THE PATIENT'S ISSUES HAVE RESOLVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 14708168 ↗
• InjuryJun 2, 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 LEFT EYE AS THE PATIENT COMPLAINED OF SEEING DOUBLE AND WAS BOTHERED BY HALOS. A VITRECTOMY WAS DONE AND A NON-JOHNSON AND JOHNSON LENS OF 19.5 DIOPTER WAS USED AS A REPLACEMENT IOL. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Impairment

  MAUDE report 14571701 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING DOUBLE VISION AND GHOSTING WITH AN INTRAOCULAR LENS (IOL) IN BOTH EYES (OU). PATIENT WAS USING OVER-THE-COUNTER (OTC) EYE DROPS AND PRESCRIPTION DROPS AS WELL (STEROID & ANTIBIOTIC DROPS). PATIENT HAD A SECOND PROCEDURE DONE ON (B)(6) 2022 THAT THE PATIENT REFERRED TO AS A ¿JAG LASER¿ PROCEDURE TO REMOVE MEMBRANES FROM HIS EYES, HOWEVER, HE IS STILL EXPERIENCING SEEING DOUBLE-IMAGES. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE STEROID AND ANTIBIOTICS EYE DROPS WERE PRESCRIBED RIGHT AFTER THE SURGERY AS A STANDARD OF CARE. THE PATIENT IS ONLY TAKING OVER-THE-COUNTER (OTC) EYE DROPS TO HELP WITH THE DRY EYES. THE PATIENT REPORTED THE DRY EYES STARTED AFTER HE GOT THE IOL IMPLANTS. THE PATIENT ALSO COMPLAINED OF NOT BEING ABLE TO SEE CLEARLY AT ALL RANGES IN BOTH EYES. PATIENT INDICATED THAT IT IS HARD TO FOCUS CLOSE-UP WHICH AFFECTS HIS WORK, BECAUSE HE IS A CRAFTSMAN AND HIS WORK HAS GONE DOWN AS A RESULT. HE ALSO IS SEEING HALOS AND GLARE AROUND LIGHTS, SEES 10-15 RINGS AROUND LIGHTS SINCE THE IOL IMPLANTS IN BOTH EYES. THE DOUBLE VISION OU GETS WORSE WITH DISTANCE VISION. THE PATIENT STATED THAT THE YTTRIUM ALUMINUM GARNET (YAG) LASER

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

  MAUDE report 14226288 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO NIGHT TIME HALOS AND POOR DISTANCE VISION. ANOTHER COMPETITOR LENS OF SAME DIOPTER WAS USED AS THE REPLACEMENT IOL. THE PATIENT WAS REPORTEDLY WELL POST-OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 14116604 ↗
• InjuryMar 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO WAS IMPLANTED WITH A SYNERGY INTRAOCULAR LENS (IOL) IN THEIR LEFT EYE COMPLAINED OF BLURRY VISION. ON (B)(6) 2021, THE DOCTOR PERFORMED A LASIK ENHANCEMENT ON THIS PATIENT TO BRING THEIR VISION INTO OPTIMAL FOCUS. LATER, THE PATIENT DEVELOPED POSTERIOR CAPSULAR OPACIFICATION (PCO) WHICH REQUIRED YTTRIUM ALUMINUM GARNET (YAG) TREATMENT. THERE WAS NO POST YAG PATIENT INJURY REPORTED. NO INFORMATION ON THE PATIENT OUTCOME WAS PROVIDED AND WAS NOTED THAT STILL NEEDS FINAL FOLLOW-UP. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 13810908 ↗